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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06526793
Registration number
NCT06526793
Ethics application status
Date submitted
3/07/2024
Date registered
30/07/2024
Date last updated
27/04/2025
Titles & IDs
Public title
AZD0486 as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL
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Scientific title
A Modular Phase 2, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of AZD0486 in Participants With Relapsed or Refractory (R/R) B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B)
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Secondary ID [1]
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2023-505789-27-00
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Secondary ID [2]
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D7404C00001
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Universal Trial Number (UTN)
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Trial acronym
SOUNDTRACK-B
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
B-cell Non-Hodgkin Lymphoma
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0
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Follicular Lymphoma (FL)
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Diffuse Large B-Cell Lymphoma (DLBCL)
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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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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 - AZD0486
Experimental: Module 1: AZD0486 Monotherapy in Participants with Relapsed or Refractory Follicular Lymphoma - In Module 1, the efficacy and safety of AZD0486 at the RP2D will be evaluated in R/R FL. AZD0486 will be administered as intravenous infusion.
Experimental: Module 2: AZD0486 Monotherapy in Participants with Relapsed or Refractory DLBCL - In Module 2, the efficacy and safety of AZD0486 at the RP2D will be evaluated in R/R DLBCL. AZD0486 will be administered as intravenous infusion.
Treatment: Drugs: AZD0486
Investigational Product administered via intravenous infusion.
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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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Overall response rate (ORR)
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Assessment method [1]
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Overall response rate (ORR), defined as the proportion of participants achieving either a PR or CR based on Lugano 2014 response criteria for non-Hodgkin Lymphoma, as determined by central review
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Timepoint [1]
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Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 12 months.
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Secondary outcome [1]
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Duration of response (DoR)
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Assessment method [1]
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Defined as the time from the date of first documented response until date of documented progression by Lugano 2014 response criteria as determined by central review or death due to any cause.
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Timepoint [1]
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To be assessed up to approximately 5 years.
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Secondary outcome [2]
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Complete response (CR) rate
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Assessment method [2]
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Complete response (CR) based on Lugano 2014 Response criteria for non-Hodgkin lymphoma, as determined by central review.
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Timepoint [2]
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To be assessed up through study completion, up to approximately 5 years
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Secondary outcome [3]
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Complete response (CR) rate
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Assessment method [3]
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Complete response (CR) based on Lugano 2014 Response criteria of non-Hodgkin lymphoma, as determined by investigator assessment.
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Timepoint [3]
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To be assessed up through study completion, up to approximately 5 years
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Secondary outcome [4]
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Overall response rate (ORR)
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Assessment method [4]
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Overall response rate (ORR), defined as the proportion of participants achieving either a PR or CR based on Lugano 2014 Response criteria of non-Hodgkin lymphoma, as determined by investigator assessment.
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Timepoint [4]
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Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 12 months.
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Secondary outcome [5]
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Duration of CR (DoCR)
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Assessment method [5]
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Defined as the time from achievement of CR to relapse or death due any cause, as assessed by central review
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Timepoint [5]
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To be assessed up to approximately 5 years.
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Secondary outcome [6]
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Time to response (TTR)
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Assessment method [6]
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Defined as the time from first dose until first documented objective response, as assessed by central review.
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Timepoint [6]
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From the first dose until the first objective response, up to approximately 5 years.
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Secondary outcome [7]
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Event-free survival (EFS)
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Assessment method [7]
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Defined as the time from first dose until disease progression, relapse, or initiation of subsequent systemic anti-lymphoma treatment, or death due to any cause, as assessed by central review.
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Timepoint [7]
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To be assessed up to approximately 5 years
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Secondary outcome [8]
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Progression-free survival (PFS)
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Assessment method [8]
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Defined as the time from the date of first dose until documented disease progression based on Lugano 2014 Response Criteria, or death due to any cause.
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Timepoint [8]
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To be assessed up to approximately 5 years.
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Secondary outcome [9]
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Time to next anti-lymphoma (TTNT)
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Assessment method [9]
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Defined as time from first dose until the start of subsequent anti-lymphoma therapy.
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Timepoint [9]
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To be assessed up to approximately 5 years.
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Secondary outcome [10]
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Overall survival (OS)
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Assessment method [10]
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Defined as the time from first dose until the date of death due to any cause.
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Timepoint [10]
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To be assessed up to approximately 5 years.
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Secondary outcome [11]
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Minimal residual disease (MRD)
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Assessment method [11]
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MRD-negative CR rate, defined as the proportion of participants who achieved MRD-negativity in plasma by NGS while in CR per the Lugano Response criteria for non-Hogkin lymphoma as determined by central review.
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Timepoint [11]
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To be assessed up through study completion, up to approximately 5 years
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Secondary outcome [12]
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Change from baseline in EORTC IL233 scales
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Assessment method [12]
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To evaluate patient-reported tolerability of AZD0486, including severity of key treatment-related symptoms and overall side-effect burden EORCT IL233 scales - European Organisation for Research and Treatment of Cancer Il233 scales- this questionnaire is assessing Patient-reported Severity of Treatment-and Disease-related Symptoms, it is a 15-item questionnaire, and each item is rated on a 4-point scale ranging from 1 (not at all) to 4 (very much).
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Timepoint [12]
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To be assessed up through study completion, up to approximately 5 years
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Secondary outcome [13]
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Change from baseline in IL232 QL2 score
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Assessment method [13]
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To evaluate patient-reported impact of disease general quality of life and functioning, while on AZD0486. EORTC IL232 - European Organisation for Research and Treatment of Cancer IL232- this questionnaire is assessing Patient-reported Severity of Treatment-and Disease-related Function and Quality of Life. This is a 15-item questionnaire, and item 1-13 are rated on a 4-point scale ranging from 1 (not at all) to 4 (very much), item 14-15 are rated on a 7-point scale ranging from 1 (very poor) to 7 (excellent).
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Timepoint [13]
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To be assessed up through study completion, up to approximately 5 years
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Secondary outcome [14]
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Change from baseline in FACT-LymS scales
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Assessment method [14]
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To evaluate patient-reported severity of key disease-related symptoms, as well as the impact of disease on lymphoma-specific concerns, while on AZD0486 Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) FACT-LymS - Lymphoma-specific Subscale from the FACT-Lym Questionnaire is a 15-item questionnaire, and each item is rated on a 5-point scale ranging from 0 (not at all) to 4 (very much).
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Timepoint [14]
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To be assessed up through study completion, up to approximately 5 years
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Secondary outcome [15]
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Change from baseline in PGI-T scale
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Assessment method [15]
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To evaluate patient-reported tolerability of AZD0486, overall side-effect burden. PGI-T scale - Patient Global Impression of Treatment Tolerability is a 1 item questionnaire rated on a 7-point scale ranging from "not at all" to "very much"
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Timepoint [15]
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To be assessed up through study completion, up to approximately 5 years
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Eligibility
Key inclusion criteria
1. Key
* Aged 18 to 80 years old
* Histologically confirmed relapsed refractory FL (Module 1) and DLBCL (Module 2) after at least 2 prior lines of therapy
* ECOG performance status 0 to 2
* Locally confirmed CD-19 expression in lymphoma cells after progression from last CD 19 directed therapy
* FDG-avid disease with at least one bi-dimensionally measurable nodal lesion (defined as > 1.5 cm in its longest dimension), or extranodal lesion (defined as > 1.0 cm in its longest dimension)
* Adequate hematological function: ANC = 1000/mm3, platelets
* 75,000/mm3, hemoglobin = 9 g/dL. Transfusion and/or growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screening
* Adequate liver function: total bilirubin <1.5x ULN, AST/ALT = 3xULN Note: Patients with documented history of Gilbert's Syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible)
* Adequate renal function: creatinine clearance (CrCl) of = 45 mL/min
The above is a summary, other inclusion criteria details may apply.
2. Key
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Minimum age
18
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation
* Active CNS involvement by B-NHL
* Leukemic presentation of B-NHL
* History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
* Prior therapy with T-cell engager (TCE) within 8 weeks, CAR T- cell therapy or autologous Hematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, or prior allogeneic HSCT within 24 weeks of first dose of AZD0486
* Requires chronic immunosuppressive therapy
* Unresolved non hematological AEs = Grade 2 from prior therapies; history of = Grade 3 CRS or neurotoxicity from prior CAR-T or TCE therapy
* History of major cardiac abnormalities.
* If female, participant must not be pregnant or breastfeeding.
The above is a summary, other exclusion criteria details may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/11/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
14/06/2029
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Actual
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Sample size
Target
240
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Heidelberg
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Recruitment hospital [2]
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Research Site - Kogarah
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Recruitment hospital [3]
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Research Site - Macquarie University
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Recruitment hospital [4]
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Research Site - Nedlands
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment postcode(s) [2]
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NSW 2217 - Kogarah
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Recruitment postcode(s) [3]
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2109 - Macquarie University
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
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California
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Florida
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Guangzhou
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Nanchang
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Nanjing
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Nantong
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Tianjin
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Zhengzhou
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Aalborg
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France
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Pierre Bénite
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France
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Rouen Cedex 1
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Berlin
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Germany
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Chemnitz
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Italy
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Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of AZD0486 monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for DLBCL.
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Trial website
https://clinicaltrials.gov/study/NCT06526793
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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AstraZeneca Clinical Study Information Center
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Address
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Country
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Phone
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1-877-240-9479
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06526793
Download to PDF