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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04680052
Registration number
NCT04680052
Ethics application status
Date submitted
17/12/2020
Date registered
22/12/2020
Date last updated
8/07/2025
Titles & IDs
Public title
A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.
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Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma
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Secondary ID [1]
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2020-004407-13
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Secondary ID [2]
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INCMOR 0208-301
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Universal Trial Number (UTN)
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Trial acronym
InMIND
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma
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Marginal Zone Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - tafasitamab
Treatment: Drugs - rituximab
Treatment: Drugs - lenalidomide
Treatment: Drugs - placebo
Experimental: Arm A : tafasitamab + rituximab + lenalidomide - Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)
Placebo comparator: Arm B : placebo+rituximab+lenalidomide - Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)
Treatment: Drugs: tafasitamab
tafasitamab will be administered IV for 12 cycles
Treatment: Drugs: rituximab
Rituximab will be administered IV on cycles 1 - 5
Treatment: Drugs: lenalidomide
Lenalidomide will be administered PO for 12 cycles
Treatment: Drugs: placebo
placebo will be administered IV for 12 cycles
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First
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Assessment method [1]
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0
PD, positron emission tomography (PET): score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, computed tomography (CT): abnormal individual node/lesion with longest diameter (LDi ) \>1.5 centimeters (cm) and increase by =50% from the product of the perpendicular diameters (PPD) nadir and increase in LDi or shortest diameter (SDi) from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.
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Timepoint [1]
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0
up to approximately 34 months
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Primary outcome [2]
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0
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
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Assessment method [2]
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PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by =50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
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Timepoint [2]
0
0
up to 2 years
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Secondary outcome [1]
0
0
Overall Population: PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
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Assessment method [1]
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PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by =50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.
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Timepoint [1]
0
0
up to approximately 34 months
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Secondary outcome [2]
0
0
Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
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Assessment method [2]
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0
PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by =50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
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Timepoint [2]
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0
up to 2 years
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Secondary outcome [3]
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FDG-avid FL Population: Positron Emission Tomography-Complete Response (PET-CR) Rate by Investigator Assessment, Using the Lugano 2014 Criteria
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Assessment method [3]
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CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake = mediastinum; 3 = uptake \> mediastinum but = liver; 4 = uptake moderately \> liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma.
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Timepoint [3]
0
0
up to approximately 34 months
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Secondary outcome [4]
0
0
FL Population: Overall Survival
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Assessment method [4]
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Overall survival was defined as the time from randomization until death from any cause.
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Timepoint [4]
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0
up to approximately 34 months
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Secondary outcome [5]
0
0
FL Population: Kaplan-Meier Estimates of Overall Survival
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Assessment method [5]
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Overall survival was defined as the time from randomization until death from any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
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Timepoint [5]
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up to 2 years
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Secondary outcome [6]
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FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria
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Assessment method [6]
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CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake = mediastinum; 3 = uptake \> mediastinum but = liver; 4 = uptake moderately \> liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma. The Overall FDG-avid Set included all randomized participants with a PET scan at Baseline with a resulting Deauville score of 4 or 5.
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Timepoint [6]
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0
up to approximately 34 months
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Secondary outcome [7]
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FL Population: Minimal Residual Disease (MRD)-Negativity Rate (at Threshold of 10^-5) at End of Treatment
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Assessment method [7]
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The MRD-negativity rate was defined as the percentage of participants who achieved a negative MRD result in peripheral blood at the End of Treatment. The threshold used for the analysis was 10\^-5 cells. MRD status was only analyzed with a threshold of =10\^-5 cells for MRD negativity.
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Timepoint [7]
0
0
up to approximately 34 months
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Secondary outcome [8]
0
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Overall Population: MRD-negativity Rate (at Threshold of 10-5) at End of Treatment
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Assessment method [8]
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0
The MRD-negativity rate was defined as the percentage of participants who achieved a negative MRD result in peripheral blood at the End of Treatment. The threshold used for the analysis was 10\^-5 cells. MRD status was only analyzed with a threshold of =10\^-5 cells for MRD negativity. The Overall MRD Blood-Evaluable Set included all participants in the Full Analysis Set who received at least 1 dose of study treatment with identifiable clonality in blood samples at Cycle 1 Day 1.
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Timepoint [8]
0
0
up to approximately 34 months
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Secondary outcome [9]
0
0
FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment
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Assessment method [9]
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0
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake = mediastinum), or 3 (uptake \> mediastinum but = liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to =1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) =50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
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Timepoint [9]
0
0
up to approximately 34 months
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Secondary outcome [10]
0
0
Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment
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Assessment method [10]
0
0
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake = mediastinum), or 3 (uptake \> mediastinum but = liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to =1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) =50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
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Timepoint [10]
0
0
up to approximately 34 months
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Secondary outcome [11]
0
0
FL Population: Duration of Response (DOR; the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
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Assessment method [11]
0
0
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake = mediastinum), or 3 (uptake \> mediastinum but = liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to =1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) =50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
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Timepoint [11]
0
0
up to approximately 34 months
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Secondary outcome [12]
0
0
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
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Assessment method [12]
0
0
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake = mediastinum), or 3 (uptake \> mediastinum but = liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to =1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) =50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
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Timepoint [12]
0
0
up to 2 years
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Secondary outcome [13]
0
0
Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
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Assessment method [13]
0
0
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake = mediastinum), or 3 (uptake \> mediastinum but = liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to =1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) =50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
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Timepoint [13]
0
0
up to approximately 34 months
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Secondary outcome [14]
0
0
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
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Assessment method [14]
0
0
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake = mediastinum), or 3 (uptake \> mediastinum but = liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to =1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) =50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
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Timepoint [14]
0
0
up to 2 years
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Secondary outcome [15]
0
0
Overall Population: Overall Survival
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Assessment method [15]
0
0
Overall survival was defined as the time from randomization until death from any cause.
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Timepoint [15]
0
0
up to approximately 34 months
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Secondary outcome [16]
0
0
Overall Population: Kaplan-Meier Estimates of Overall Survival
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Assessment method [16]
0
0
Overall survival was defined as the time from randomization until death from any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
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Timepoint [16]
0
0
up to 2 years
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Secondary outcome [17]
0
0
FL Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
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Assessment method [17]
0
0
PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by =50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.
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Timepoint [17]
0
0
up to approximately 34 months
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Secondary outcome [18]
0
0
FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
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Assessment method [18]
0
0
PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by =50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
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Timepoint [18]
0
0
up to 2 years
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Secondary outcome [19]
0
0
Overall Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
Query!
Assessment method [19]
0
0
PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by =50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.
Query!
Timepoint [19]
0
0
up to approximately 34 months
Query!
Secondary outcome [20]
0
0
Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
Query!
Assessment method [20]
0
0
PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by =50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Query!
Timepoint [20]
0
0
up to 2 years
Query!
Secondary outcome [21]
0
0
FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review
Query!
Assessment method [21]
0
0
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake = mediastinum), or 3 (uptake \> mediastinum but = liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to =1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) =50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Query!
Timepoint [21]
0
0
up to approximately 34 months
Query!
Secondary outcome [22]
0
0
Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review
Query!
Assessment method [22]
0
0
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake = mediastinum), or 3 (uptake \> mediastinum but = liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to =1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) =50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Query!
Timepoint [22]
0
0
up to approximately 34 months
Query!
Secondary outcome [23]
0
0
FL Population: DOR the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
Query!
Assessment method [23]
0
0
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake = mediastinum), or 3 (uptake \> mediastinum but = liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to =1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) =50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Query!
Timepoint [23]
0
0
up to approximately 34 months
Query!
Secondary outcome [24]
0
0
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
Query!
Assessment method [24]
0
0
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake = mediastinum), or 3 (uptake \> mediastinum but = liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to =1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) =50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Query!
Timepoint [24]
0
0
up to 2 years
Query!
Secondary outcome [25]
0
0
Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
Query!
Assessment method [25]
0
0
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake = mediastinum), or 3 (uptake \> mediastinum but = liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to =1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) =50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Query!
Timepoint [25]
0
0
up to approximately 34 months
Query!
Secondary outcome [26]
0
0
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
Query!
Assessment method [26]
0
0
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake = mediastinum), or 3 (uptake \> mediastinum but = liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to =1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) =50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Query!
Timepoint [26]
0
0
up to 2 years
Query!
Secondary outcome [27]
0
0
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Query!
Assessment method [27]
0
0
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) version 3 is a 30-item scale composed of both multi-item scales and single-item measures. These include 5 functional scales (physical functioning, role, cognitive functioning, emotional functioning, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status scale, and 6 single items (constipation, diarrhea, sleep, dyspnea, appetite, financial). All scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Therefore, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Query!
Timepoint [27]
0
0
up to approximately 34 months
Query!
Secondary outcome [28]
0
0
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Query!
Assessment method [28]
0
0
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) version 3 is a 30-item scale composed of both multi-item scales and single-item measures. These include 5 functional scales (physical functioning, role, cognitive functioning, emotional functioning, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status scale, and 6 single items (constipation, diarrhea, sleep, dyspnea, appetite, financial). All scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Therefore, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Query!
Timepoint [28]
0
0
up to approximately 34 months
Query!
Secondary outcome [29]
0
0
FL Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment
Query!
Assessment method [29]
0
0
The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.
Query!
Timepoint [29]
0
0
up to approximately 34 months
Query!
Secondary outcome [30]
0
0
Overall Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment
Query!
Assessment method [30]
0
0
The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.
Query!
Timepoint [30]
0
0
up to approximately 34 months
Query!
Secondary outcome [31]
0
0
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Query!
Assessment method [31]
0
0
The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.
Query!
Timepoint [31]
0
0
up to approximately 34 months
Query!
Secondary outcome [32]
0
0
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Query!
Assessment method [32]
0
0
The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.
Query!
Timepoint [32]
0
0
up to approximately 34 months
Query!
Secondary outcome [33]
0
0
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
Query!
Assessment method [33]
0
0
The FACT-Lymphoma (v4) is composed of 42 items with a 5-point Likert-type scale and 5 subscales. Physical well-being (PWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Social/family well-being (SWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Emotional well-being (EWB) subscale: 6 items measured on 0- to 4-point scale; total score = 0-24. Functional well-being (FWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Lymphoma (LymS) subscale includes 15 items; total score = 0-60. Three total scores can be derived by adding the subscales: FACT-Lymphoma Trial Outcome Index (TOI): (PWB score) + (FWB score) + (LymS score); total score = 0-116. FACT-G total score: (PWB score) + (SWB score) + (EWB score) + (FWB score); total score = 0-108. FACT-Lymphoma total score: (PWB score) + (SWB score) + (EWB score) + (FWB score) + (LymS score); total score = 0-168. The higher the score, the better the quality of life.
Query!
Timepoint [33]
0
0
up to approximately 34 months
Query!
Secondary outcome [34]
0
0
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
Query!
Assessment method [34]
0
0
The FACT-Lymphoma (v4) is composed of 42 items with a 5-point Likert-type scale and 5 subscales. Physical well-being (PWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Social/family well-being (SWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Emotional well-being (EWB) subscale: 6 items measured on 0- to 4-point scale; total score = 0-24. Functional well-being (FWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Lymphoma (LymS) subscale includes 15 items; total score = 0-60. Three total scores can be derived by adding the subscales: FACT-Lymphoma Trial Outcome Index (TOI): (PWB score) + (FWB score) + (LymS score); total score = 0-116. FACT-G total score: (PWB score) + (SWB score) + (EWB score) + (FWB score); total score = 0-108. FACT-Lymphoma total score: (PWB score) + (SWB score) + (EWB score) + (FWB score) + (LymS score); total score = 0-168. The higher the score, the better the quality of life.
Query!
Timepoint [34]
0
0
up to approximately 34 months
Query!
Eligibility
Key inclusion criteria
* Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
* Willingness to avoid pregnancy or fathering children
* In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin)
* Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy
* Documented relapsed, refractory, or PD after treatment with systemic therapy
* ECOG performance status of 0 to 2
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Women who are pregnant or breastfeeding.
* Any histology other than FL and MZL or clinical evidence of transformed lymphoma
* Prior non-hematologic malignancy
* Congestive heart failure
* HCV positivity, chronic HBV infection or history of HIV infection
* Active systemic infection
* CNS lymphoma involvement
* Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1
* Prior use of lenalidomide in combination with rituximab
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
15/04/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
9/08/2028
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
654
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
St George Hospital - Kogarah
Query!
Recruitment hospital [2]
0
0
Liverpool Hospital - Sydney
Query!
Recruitment hospital [3]
0
0
Wollongong Hospital - Illawarra Regional Hospital - Wollongong
Query!
Recruitment hospital [4]
0
0
Gold Coast Hospital - Southport
Query!
Recruitment hospital [5]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [6]
0
0
Flinders Medical Centre - Bedford Park
Query!
Recruitment hospital [7]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment hospital [8]
0
0
Northern Hospital - Melbourne
Query!
Recruitment hospital [9]
0
0
Western Health - St. Albans
Query!
Recruitment hospital [10]
0
0
Perth Blood Institute - West Perth
Query!
Recruitment hospital [11]
0
0
Eastern Health - Box Hill
Query!
Recruitment hospital [12]
0
0
Royal Hobart Hospital - Hobart
Query!
Recruitment postcode(s) [1]
0
0
02217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
02170 - Sydney
Query!
Recruitment postcode(s) [3]
0
0
02500 - Wollongong
Query!
Recruitment postcode(s) [4]
0
0
04215 - Southport
Query!
Recruitment postcode(s) [5]
0
0
05000 - Adelaide
Query!
Recruitment postcode(s) [6]
0
0
05042 - Bedford Park
Query!
Recruitment postcode(s) [7]
0
0
03004 - Melbourne
Query!
Recruitment postcode(s) [8]
0
0
03076 - Melbourne
Query!
Recruitment postcode(s) [9]
0
0
03021 - St. Albans
Query!
Recruitment postcode(s) [10]
0
0
06005 - West Perth
Query!
Recruitment postcode(s) [11]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [12]
0
0
07000 - Hobart
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Connecticut
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Hawaii
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Iowa
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kentucky
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Louisiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Michigan
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Minnesota
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Mississippi
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New York
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
North Carolina
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Oklahoma
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
South Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
South Dakota
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Texas
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Utah
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Virginia
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Washington
Query!
Country [22]
0
0
Austria
Query!
State/province [22]
0
0
Graz
Query!
Country [23]
0
0
Austria
Query!
State/province [23]
0
0
Innsbruck
Query!
Country [24]
0
0
Austria
Query!
State/province [24]
0
0
Linz
Query!
Country [25]
0
0
Austria
Query!
State/province [25]
0
0
Wien
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Antwerpen
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Brugge
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Brussels
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Edegem
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Gent
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Leuven
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Liège
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Roeselare
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Yvoir
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Alberta
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
British Columbia
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Nova Scotia
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Ontario
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Quebec
Query!
Country [40]
0
0
Czechia
Query!
State/province [40]
0
0
Brno
Query!
Country [41]
0
0
Czechia
Query!
State/province [41]
0
0
Hradec Kralove
Query!
Country [42]
0
0
Czechia
Query!
State/province [42]
0
0
Ostrava
Query!
Country [43]
0
0
Czechia
Query!
State/province [43]
0
0
Prague
Query!
Country [44]
0
0
Czechia
Query!
State/province [44]
0
0
Praha
Query!
Country [45]
0
0
Denmark
Query!
State/province [45]
0
0
Aalborg
Query!
Country [46]
0
0
Denmark
Query!
State/province [46]
0
0
Aarhus
Query!
Country [47]
0
0
Denmark
Query!
State/province [47]
0
0
Odense
Query!
Country [48]
0
0
Denmark
Query!
State/province [48]
0
0
Roskilde
Query!
Country [49]
0
0
Finland
Query!
State/province [49]
0
0
Kuopio
Query!
Country [50]
0
0
Finland
Query!
State/province [50]
0
0
Oulu
Query!
Country [51]
0
0
Finland
Query!
State/province [51]
0
0
Tampere
Query!
Country [52]
0
0
Finland
Query!
State/province [52]
0
0
Turku
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Amiens
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Angers
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Bordeaux
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Dijon
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Le Chesnay
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Nantes
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Paris
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Pontoise
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Pringy
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Tours
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Amberg
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Berlin
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Essen
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
GIEßEN
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Greifswald
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Landshut
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Mainz
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Mannheim
Query!
Country [71]
0
0
Germany
Query!
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Israel
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Terrassa
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Valencia
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Taipei
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Ankara
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Istanbul
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Kharkiv
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Ukraine
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Kyiv
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Birmingham
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Bristol
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Leicester
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London
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Sutton
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Incyte Corporation
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Address
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Ethics approval
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Summary
Brief summary
This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.
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Trial website
https://clinicaltrials.gov/study/NCT04680052
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Public notes
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Contacts
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Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/52/NCT04680052/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/52/NCT04680052/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04680052
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