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A Study Evaluating the Safety and Efficacy of Venetoclax (GDC-0199) Plus Bendamustine + Rituximab (BR) in Comparison With BR or Venetoclax Plus Rituximab in Participants With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma (fNHL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02187861
Recruitment Status : Completed
First Posted : July 11, 2014
Results First Posted : October 13, 2017
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This open-label, international, multicenter study will investigate the safety and efficacy of venetoclax (GDC-0199) in combination with bendamustine plus rituximab (venetoclax + BR) compared with BR alone in participants with relapsed and refractory fNHL, comparing two chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an exploratory analysis of the safety and efficacy of venetoclax in combination with rituximab (venetoclax + rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be decided at the discretion of the Investigator, unless one of the cohorts is not open to enrollment; in which case, participants may be enrolled only to the open cohort. The first 6 participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will comprise the Safety Run-In group for Treatment Arm B, dosing venetoclax at 600 milligrams (mg) in combination with BR. Once a dose has been chosen from the Safety Run-In Period, randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C) will begin.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Drug: Venetoclax Drug: Bendamustine Drug: Rituximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label Study Evaluating the Safety and Efficacy of GDC-0199 (ABT-199) Plus Bendamustine Plus Rituximab (BR) in Comparison With BR Alone or GDC-0199 Plus Rituximab (R) in Patients With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma
Actual Study Start Date : December 1, 2014
Actual Primary Completion Date : September 27, 2016
Actual Study Completion Date : March 16, 2018


Arm Intervention/treatment
Experimental: Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)
Participants will receive venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in will continue until first 9 participants complete the safety observation window of 28 days. Participants will continue receiving the same treatment as decided for Arm B.
Drug: Venetoclax
Venetoclax will be administered as per the schedule specified under arm description.
Other Names:
  • GDC-0199
  • ABT-199

Drug: Bendamustine
Bendamustine will be administered as per the schedule specified under arm description.
Other Name: Levact

Drug: Rituximab
Rituximab will be administered as per the schedule specified under arm description.
Other Names:
  • MabThera
  • Rituxan

Experimental: Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)
Participants will receive venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle will be of 28 days.
Drug: Venetoclax
Venetoclax will be administered as per the schedule specified under arm description.
Other Names:
  • GDC-0199
  • ABT-199

Drug: Rituximab
Rituximab will be administered as per the schedule specified under arm description.
Other Names:
  • MabThera
  • Rituxan

Experimental: Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)
Participants will receive venetoclax at doses decided from safety run-in orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Drug: Venetoclax
Venetoclax will be administered as per the schedule specified under arm description.
Other Names:
  • GDC-0199
  • ABT-199

Drug: Bendamustine
Bendamustine will be administered as per the schedule specified under arm description.
Other Name: Levact

Drug: Rituximab
Rituximab will be administered as per the schedule specified under arm description.
Other Names:
  • MabThera
  • Rituxan

Active Comparator: Chemotherapy-Containing Cohort: Arm C (BR)
Participants will receive rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Drug: Bendamustine
Bendamustine will be administered as per the schedule specified under arm description.
Other Name: Levact

Drug: Rituximab
Rituximab will be administered as per the schedule specified under arm description.
Other Names:
  • MabThera
  • Rituxan




Primary Outcome Measures :
  1. Percentage of Participants With Complete Metabolic Response (CMR) According to Independent Review Committee (IRC) as Per Lugano Classification, Using Positron Emission Tomography (PET) Scan at Primary Response Assessment (PRA) [ Time Frame: 6-8 weeks after Cycle 6 Day 1 (PRA) (Cycle length = 28 days) ]
    CMR: a score 1 (no uptake above background), 2 (uptake less than or equal to [<=] mediastinum), or 3 (uptake less than [<] mediastinum but <=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites with no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method.


Secondary Outcome Measures :
  1. Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at PRA [ Time Frame: 4-10 weeks after Cycle 6 Day 1 (Cycle length = 28 days) ]
    CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.

  2. Percentage of Participants With CMR According to IRC as Per Lugano Classification, Using PET Scan at Year 1 [ Time Frame: 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) ]
    CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (uptake <mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.

  3. Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at Year 1 [ Time Frame: 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) ]
    CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.

  4. Percentage of Participants With Complete Response (CR) According to IRC as Per Lugano Classification, Using Computed Tomography (CT) Scan [ Time Frame: 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) ]
    CR: defined as reduction of longest transverse diameter of lesion (LDi) of target nodes/nodal masses to <=1.5 centimeters (cm), and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.

  5. Percentage of Participants With CR According to Investigator as Per Lugano Classification, Using CT Scan [ Time Frame: 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) ]
    CR: defined as reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.

  6. Percentage of Participants With Objective Response (OR) According to IRC as Per Lugano Classification, Using PET Scan [ Time Frame: 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) ]
    OR was defined as CMR or Partial Metabolic Response (PMR). CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.

  7. Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET Scan [ Time Frame: 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) ]
    OR was defined as CMR or PMR. CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.

  8. Percentage of Participants With OR According to IRC as Per Lugano Classification, Using CT Scan [ Time Frame: 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) ]
    OR was defined as CR or Partial Response (PR). CR: reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: greater than or equal to (>=) 50 percent (%) decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least >50% beyond normal; and no new lesions. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.

  9. Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using CT Scan [ Time Frame: 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) ]
    OR was defined as CR or PR. CR: reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: >=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least >50% beyond normal; and no new lesions. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.

  10. Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET or CT Scan [ Time Frame: Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years) ]
    OR was defined as CMR/CR or PMR/PR. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing).

  11. Duration of Response (DOR) According to Investigator as Per Lugano Classification, Using PET or CT Scan [ Time Frame: From CMR or PMR until disease progression or death due to any cause (assessed up to approximately 2.5 years) ]
    DOR was defined as time from CMR/CR or PMR/PR until progressive disease (PD) or death due to any cause. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing). DOR was calculated using Kaplan-Meier method.

  12. Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan) or Death [ Time Frame: Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years) ]
    PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.

  13. Progression-Free Survival (PFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan [ Time Frame: Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years) ]
    PFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) until the date of disease progression, or death due to any cause. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. PFS was calculated using Kaplan-Meier method.

  14. Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan), Death, or Start of a New Anti-lymphoma Therapy [ Time Frame: Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years) ]
    PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.

  15. Event-Free Survival (EFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan [ Time Frame: Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years) ]
    EFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to the date of disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. EFS was calculated using Kaplan-Meier method.

  16. Percentage of Participants Who Died Due to Any Cause [ Time Frame: Baseline until death due to any cause (assessed up to approximately 2.5 years ]
  17. Overall Survival (OS) [ Time Frame: Baseline until death due to any cause (assessed up to approximately 2.5 years) ]
    OS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to death due to any cause. For participants who are alive, OS was censored at the last contact. OS was calculated using Kaplan-Meier method.

  18. Apparent Clearance (CL) of Venetoclax [ Time Frame: Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) ]
    CL is a quantitative measure of the rate at which a drug substance is removed from the body.

  19. Apparent Volume of Distribution (Vd) of Venetoclax [ Time Frame: Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) ]
    Vd was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.

  20. Time to Maximum Plasma Concentration (Tmax) of Venetoclax [ Time Frame: Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) ]
  21. Maximum Plasma Concentration (Cmax) of Venetoclax [ Time Frame: Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) ]
  22. Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Concentration (AUClast) of Venetoclax [ Time Frame: Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) ]
    Area under the plasma concentration versus time curve from zero to the last measured concentration (AUClast).

  23. Area Under the Plasma Concentration-Time Curve From Time 0 to 8 Hours Post Dose (AUC0-8h) of Venetoclax [ Time Frame: Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) ]
    Area under the plasma concentration versus time curve from time 0 (pre-dose) to 8 hours post dose (AUC0-8h).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have histologically confirmed follicular lymphoma (FL) of Grade 1, 2, or 3a
  • Participants must have received at least one prior therapy for FL
  • For participants potentially receiving chemotherapy: if the participant has received prior bendamustine, response duration must have been greater than (>) 1 year
  • At least one bi-dimensionally measurable lesion on imaging scan defined as >1.5 centimeters (cm) in its longest dimension
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Adequate hematologic function
  • For female participants of childbearing potential and male participants with female partners of childbearing potential, agreement to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception throughout the course of study treatment and for at least 30 days after the last dose of venetoclax and 12 months after the last dose of rituximab, whichever is longer
  • Confirmed availability of archival or freshly biopsied tumor tissue meeting protocol-defined specifications prior to study enrollment

Exclusion Criteria:

  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
  • Contraindication to potential treatment agents
  • Ongoing corticosteroid use >30 milligrams per day (mg/day) of prednisone or equivalent. Participants receiving corticosteroid treatment with less than equal to (</=) 30 mg/day of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks duration prior to randomization (Cycle 1 Day 1)
  • Primary central nervous system (CNS) lymphoma
  • Vaccination with live vaccines within 28 days prior to treatment
  • Chemotherapy or other investigational therapy within five half-lives of a biologic agent with a minimum of 28 days prior to the start of Cycle 1
  • History of other malignancy that could affect compliance with the protocol or interpretation of results
  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the participant
  • Significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, congestive heart failure, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day 1
  • Requires the use of warfarin
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Presence of positive test results for hepatitis B surface antigen or hepatitis C virus (HCV) antibody
  • Participants who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation
  • Participants with occult or prior hepatitis B virus (HBV) infection may be included if HBV deoxyribonucleic acid (DNA) is undetectable at screening. These participants must be willing to undergo monthly HBV DNA test until at least 12 months after the last treatment cycle
  • Known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus 1 (HTLV-1)
  • Pregnant or lactating
  • Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1), other than for diagnosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02187861


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Locations
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United States, Alabama
Southern Cancer Center, PC
Mobile, Alabama, United States, 36608
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85719
United States, California
UCLA School of Medicine; Hematology/Oncology
Los Angeles, California, United States, 90095
United States, Georgia
Nothwest Georgia Oncology Centers P.C
Austell, Georgia, United States, 30106
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University of Illinois at Chicago College of Medicine
Chicago, Illinois, United States, 60612-7302
Primary Healthcare Associates SC - Harvey
Harvey, Illinois, United States, 60426
United States, Kansas
University of Kansas; Medical Center & Medical pavilion
Westwood, Kansas, United States, 66205
United States, Maryland
Sidney Kimmel Comp Cancer Ctr
Baltimore, Maryland, United States, 21231-1000
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
United States, Pennsylvania
University of Pennsylvania; School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
VCU Massey Cancer Center
Richmond, Virginia, United States, 23298-003
United States, West Virginia
West Virginia Uni Med. Center - Robert Byrd Health Science
Morgantown, West Virginia, United States, 26506
Australia, New South Wales
Royal Prince Alfred Hospital; Medical Oncology
Camperdown, New South Wales, Australia, 2050
St George Hospital
Kogarah, New South Wales, New South Wales, Australia, 2217
Royal North Shore Hospital
St. Leonards, New South Wales, Australia, 2065
Westmead Hospital; Haematology
Sydney, New South Wales, Australia, 2145
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Townsville General Hospital
Douglas, Queensland, Australia, 4184
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Queen Elizabeth Hospital; Haematology
Woodville South, South Australia, Australia, 5011
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Belgium
ZNA Stuivenberg
Antwerpen, Belgium, 2060
AZ Sint Jan
Brugge, Belgium, 8000
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, Ontario
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Maisonneuve- Rosemont; Oncology
Montreal, Quebec, Canada, H1T 2M4
Chum Hopital Notre Dame; Centre D'Oncologie
Montreal, Quebec, Canada, H2L 4M1
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Canada, Saskatchewan
Saskatoon Cancer Centre; Uni of Saskatoon Campus
Saskatoon, Saskatchewan, Canada, S7N 4H4
France
Institut de Cancerologie de l'Ouest
Angers, France, 49933
CHU Clermont Ferrand - Hôpital d'Estaing
Clermont Ferrand cedex 1, France, 63003
Hopital Henri Mondor
Creteil, France, 94010
CHU de Dijon - Hopital le Bocage
Dijon, France, 21000
Centre Jean Bernard
Le Mans, France, 72015
CHU Montpellier
Montpellier, France, 34295
Centre Hospitalier Lyon Sud; Hematolgie
Pierre Benite, France, 69495
Germany
Klinikum Chemnitz gGmbH; Klinik f. Innere Medizin III
Chemnitz, Germany, 09116
Städtisches Klinikum Dessau
Dessau-Roßlau, Germany, 06847
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, Germany, 01307
Universitätsklinik Essen; Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Essen, Germany, 45122
Universitätsklinikum Jena; Klinik für Innere Medizin II
Jena, Germany, 07747
Universitätsklinikum Köln; Klinik I für Innere Medizin
Koeln, Germany, 50937
Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Hämatologie/Onkologie
Lübeck, Germany, 23562
Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik
Mainz, Germany, 55131
Universitätsklinikum Ulm; Apotheke
Ulm, Germany, 89075
Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie
Würzburg, Germany, 97080
Italy
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, Italy, 40138
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, Italy, 47014
Ospedale di Ravenna
Ravenna, Emilia-Romagna, Italy, 48100
Ospedale Infermi di Rimini
Rimini, Emilia-Romagna, Italy, 47900
Asst Papa Giovanni XXIII
Bergamo, Lombardia, Italy, 24100
Ospedale Niguarda Milano
Milano, Lombardia, Italy, 20162
Irccs Policlinico San Matteo; Divisione Di Ematologia
Pavia, Lombardia, Italy, 27100
Azienda Ospedale San Giovanni
Torino, Piemonte, Italy, 10126
Az. Osp. Di Careggi; Divisione Di Ematologia
Firenze, Toscana, Italy, 50135
United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom, FY3 8NR
St James University Hospital
Leeds, United Kingdom, LS9 7TF
Leicester Royal Infirmary; Dept. of Medical Oncology
Leicester, United Kingdom, LE1 5WW
University College London, Department of Haematology
London, United Kingdom, NW1 2PG
Royal Marsden Nhs Trust; Consultant Cancer Physician
London, United Kingdom, SW3 6JJ
Christie Hospital; Breast Cancer Research Office
Manchester, United Kingdom, M20 4QL
Churchill Hospital; Oxford Cancer and Haematology Centre
Oxford, United Kingdom, OX3 7LJ
Royal Marsden NHS Foundation Trust
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Hoffmann-La Roche
AbbVie
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02187861     History of Changes
Other Study ID Numbers: BO29337
2014-000576-26 ( EudraCT Number )
First Posted: July 11, 2014    Key Record Dates
Results First Posted: October 13, 2017
Last Update Posted: June 5, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Venetoclax
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Bendamustine Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action