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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01974440




Registration number
NCT01974440
Ethics application status
Date submitted
28/10/2013
Date registered
1/11/2013
Date last updated
9/08/2024

Titles & IDs
Public title
A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL)
Secondary ID [1] 0 0
PCI-32765FLR3001
Secondary ID [2] 0 0
CR102786
Universal Trial Number (UTN)
Trial acronym
SELENE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bendamustine
Treatment: Drugs - Rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisone
Treatment: Drugs - PCI-32765 (Ibrutinib)
Treatment: Drugs - Placebo

Placebo comparator: Treatment Arm A - Treatment Arm A = background immune-chemotherapy (bendamustine and rituximab \[BR\] or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone \[R-CHOP\]) for 6 cycles + placebo.

Experimental: Treatment Arm B - Treatment Arm B = background immune-chemotherapy (BR or R-CHOP) for 6 cycles + PCI-32765 (Ibrutinib).


Treatment: Drugs: Bendamustine
90 milligram per meter square (mg/m\^2) administered intravenously on Days 1 to 2 of Cycles 1 to 6.

Treatment: Drugs: Rituximab
375 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6.

Treatment: Drugs: Cyclophosphamide
750 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6.

Treatment: Drugs: Doxorubicin
50 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6.

Treatment: Drugs: Vincristine
1.4 mg/m\^2 (maximum total 2 mg) administered intravenously on Day 1 of Cycles 1 to 6.

Treatment: Drugs: Prednisone
100 mg administered orally on Days 1 to 5 of Cycles 1 to 6.

Treatment: Drugs: PCI-32765 (Ibrutinib)
560 mg (4\*140 mg) capsules administered orally once daily, continuously starting on Cycle 1, Day 1.

Treatment: Drugs: Placebo
Placebo (4 capsules) matched to ibrutinib administered orally once daily, continuously starting on Cycle 1, Day 1.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Analysis: Progression Free Survival (PFS): Stratified Analysis
Timepoint [1] 0 0
Up to 8 years
Primary outcome [2] 0 0
Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL)
Timepoint [2] 0 0
Up to 8 years
Secondary outcome [1] 0 0
Primary Analysis: Overall Survival (OS): Stratified Analysis
Timepoint [1] 0 0
Up to 8 years
Secondary outcome [2] 0 0
Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL
Timepoint [2] 0 0
Up to 8 years
Secondary outcome [3] 0 0
Primary Analysis: Complete Response Rate (CRR): Stratified Analysis
Timepoint [3] 0 0
Up to 8 years
Secondary outcome [4] 0 0
Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL
Timepoint [4] 0 0
Up to 8 years
Secondary outcome [5] 0 0
Primary Analysis: Overall Response Rate (ORR): Stratified Analysis
Timepoint [5] 0 0
Up to 8 years
Secondary outcome [6] 0 0
Supplementary Analysis: Overall Response Rate: Unstratified Analysis - Participants With MZL
Timepoint [6] 0 0
Up to 8 years
Secondary outcome [7] 0 0
Primary Analysis: Duration of Response (DOR): Stratified Analysis
Timepoint [7] 0 0
Up to 8 years
Secondary outcome [8] 0 0
Supplementary Analysis: Duration of Response: Unstratified Analysis - Participants With MZL
Timepoint [8] 0 0
Up to 8 years
Secondary outcome [9] 0 0
Primary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire
Timepoint [9] 0 0
Up to 8 years
Secondary outcome [10] 0 0
Supplementary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire: Participants With MZL
Timepoint [10] 0 0
Up to 8 years
Secondary outcome [11] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [11] 0 0
Placebo + Chemoimmunotherapy (CIT) arm: From Day 1 up to 30 days after date of last dose of study medication (up to 8 years); Ibrutinib + CIT arm: From Day 1 up to 30 days after date of last dose of study medication (up to 8 years 8 months)
Secondary outcome [12] 0 0
Number of Participants With TEAEs: Participants With MZL
Timepoint [12] 0 0
Placebo + Chemoimmunotherapy (CIT) arm: From Day 1 up to 30 days after date of last dose of study medication (up to 8 years); Ibrutinib + CIT arm: From Day 1 up to 30 days after date of last dose of study medication (up to 8 years 8 months)

Eligibility
Key inclusion criteria
* Histologically confirmed diagnosis of B-cell indolent Non-Hodgkin lymphoma with histological subtype limited to follicular lymphoma or marginal zone lymphoma, at initial diagnosis and without evidence of pathological transformation or clinical signs suggesting transformation
* At least 1 prior treatment with a CD20 antibody combination chemo-immunotherapy regimen
* Disease that has relapsed or was refractory after prior chemo-immunotherapy
* At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma 2007
* Eastern Cooperative Oncology Group performance status grade 0 or 1
* Laboratory values within protocol-defined parameters
* Agrees to protocol-defined use of effective contraception
* Men must agree not to donate sperm during and after the study for 6 months after the last dose of bendamustine, 12 months after the last dose of rituximab, or 3 months after the last dose of study medication, whichever is later
* Women of childbearing potential must have a negative serum or urine pregnancy test at Screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment according to protocol-defined criteria
* Unable to receive background chemotherapy based on prior treatment history and cardiac function
* Known central nervous system lymphoma
* Diagnosed or treated for malignancy other than indolent Non-Hodgkin lymphoma
* History of stroke or intracranial hemorrhage within 6 months prior to randomization
* Requires anticoagulation with warfarin or equivalent Vitamin K antagonists
* Requires treatment with strong CYP3A inhibitors
* Clinically significant cardiovascular disease
* Known history of human immunodeficiency virus or active hepatitis C virus (HCV; ribonucleic acid [RNA] polymerase chain reaction [PCR]-positive) or active hepatitis B virus (HBV; DNA PCR-positive) infection or any uncontrolled active systemic infection requiring intravenous antibiotics
* Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
* Women who are pregnant or breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/06/2023
Sample size
Target
Accrual to date
Final
403
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Fitzroy
Recruitment hospital [3] 0 0
- Heidelberg
Recruitment hospital [4] 0 0
- South Brisbane
Recruitment hospital [5] 0 0
- Wahroonga
Recruitment hospital [6] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Heidelberg
Recruitment postcode(s) [4] 0 0
- South Brisbane
Recruitment postcode(s) [5] 0 0
- Wahroonga
Recruitment postcode(s) [6] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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California
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Florida
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Illinois
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Indiana
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Kansas
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Kentucky
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United States of America
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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New Jersey
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New York
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North Carolina
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Oregon
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Pennsylvania
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South Dakota
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Texas
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Cordoba
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Argentina
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La Capital
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Argentina
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Mendoza
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Argentina
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Santa Fe
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Belgium
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Anderlecht
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Namur
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Belgium
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Wilrijk
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Brazil
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Porto Alegre
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Brazil
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Rio De Janeiro
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Brazil
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Salvador
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Brazil
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Sao Paulo
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Brazil
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São Paulo
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China
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Beijing
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China
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Chengdu
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China
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China
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Hangzhou
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China
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Harbin
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China
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Nanjing
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China
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Shanghai
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China
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Tianjin
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France
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Nice Cedex 2
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France
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Paris
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France
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Pessac
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France
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Pierre Benite
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France
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Rennes
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Germany
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Berlin
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Gießen
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Germany
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Göttingen
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Germany
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Ludwigshafen, Rp
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Magdeburg
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Germany
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Mainz
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Munchen
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Israel
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Hadera
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Haifa
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Jerusalem
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Nahariya
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Netanya
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Petah Tikva
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Ramat Gan
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Chuo Ku
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Hiroshima shi
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Kobe
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Nagoya-shi
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Osaka Sayama shi
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Japan
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Sapporo-shi
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Sendai shi
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Suita-shi
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Tokyo
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Seoul
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Poland
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Bayamon
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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Nizny Novgorod
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Russian Federation
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Petrozavodsk
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Russian Federation
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Pyatigorsk
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Russian Federation
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Rostov-On-Don
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Russian Federation
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St. Petersburg
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Russian Federation
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Syktyvkar
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Russian Federation
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Volgograd
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Pozuelo de Alarcon
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Spain
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Salamanca
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Sweden
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Göteborg
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Sweden
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Linköping
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Sweden
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Luleå
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Sweden
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Uppsala
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kayseri
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Ukraine
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Cherkasy
Country [109] 0 0
Ukraine
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Ivano-Frankivsk
Country [110] 0 0
Ukraine
State/province [110] 0 0
Khmelnitskiy
Country [111] 0 0
Ukraine
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Kiev
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Ukraine
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Lviv
Country [113] 0 0
Ukraine
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Uzhgorod
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Glasgow
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United Kingdom
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London
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Plymouth
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United Kingdom
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Portsmouth
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United Kingdom
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Sutton
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pharmacyclics LLC.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult participants with previously treated indolent Non-Hodgkin lymphoma.
Trial website
https://clinicaltrials.gov/study/NCT01974440
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01974440