Follicular LymphomaPhase 2NCT02187861
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)
A Phase 2 study testing Venetoclax, Bendamustine and Rituximab in people with Follicular Lymphoma, run by Hoffmann-La Roche at 71 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Venetoclax, Bendamustine and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 71 sitesin 8 countries
- Study dates
- 1 Dec 2014to 16 Mar 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
71 sites in 8 countries.
71 sites in 8 countries
United States17 sites
Nothwest Georgia Oncology Centers P.C
Austell, Georgia, 30106
Sidney Kimmel Comp Cancer Ctr
Baltimore, Maryland, 21231-1000
University of Virginia
Charlottesville, Virginia, 22903
Northwestern University
Chicago, Illinois, 60611
University of Illinois at Chicago College of Medicine
Chicago, Illinois, 60612-7302
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Primary Healthcare Associates SC - Harvey
Harvey, Illinois, 60426
UCLA School of Medicine; Hematology/Oncology
Los Angeles, California, 90095
Southern Cancer Center, PC
Mobile, Alabama, 36608
West Virginia Uni Med. Center - Robert Byrd Health Science
Morgantown, West Virginia, 26506
University of Pennsylvania; School of Medicine
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
VCU Massey Cancer Center
Richmond, Virginia, 23298-003
James P. Wilmot Cancer Center
Rochester, New York, 14642
Arizona Cancer Center
Tucson, Arizona, 85719
University of Kansas; Medical Center & Medical pavilion
Westwood, Kansas, 66205
Australia10 sites
Royal Prince Alfred Hospital; Medical Oncology
Camperdown, New South Wales, 2050
Monash Medical Centre
Clayton, Victoria, 3168
Townsville General Hospital
Douglas, Queensland, 4184
Royal Hobart Hospital
Hobart, Tasmania, 7000
St George Hospital
Kogarah, New South Wales, New South Wales, 2217
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Westmead Hospital; Haematology
Sydney, New South Wales, 2145
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Queen Elizabeth Hospital; Haematology
Woodville South, South Australia, 5011
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Germany10 sites
Klinikum Chemnitz gGmbH; Klinik f. Innere Medizin III
Chemnitz, 09116
Universitätsklinikum Köln; Klinik I für Innere Medizin
Cologne, 50937
Städtisches Klinikum Dessau
Dessau, 06847
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, 01307
Universitätsklinik Essen; Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Essen, 45122
Universitätsklinikum Jena; Klinik für Innere Medizin II
Jena, 07747
Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Hämatologie/Onkologie
Lübeck, 23562
Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik
Mainz, 55131
Universitätsklinikum Ulm; Apotheke
Ulm, 89075
Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie
Würzburg, 97080
Italy9 sites
Asst Papa Giovanni XXIII
Bergamo, Lombardy, 24100
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, 40138
Az. Osp. Di Careggi; Divisione Di Ematologia
Florence, Tuscany, 50135
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, 47014
Ospedale Niguarda Milano
Milan, Lombardy, 20162
Irccs Policlinico San Matteo; Divisione Di Ematologia
Pavia, Lombardy, 27100
Ospedale di Ravenna
Ravenna, Emilia-Romagna, 48100
Ospedale Infermi di Rimini
Rimini, Emilia-Romagna, 47900
Azienda Ospedale San Giovanni
Turin, Piedmont, 10126
United Kingdom8 sites
Blackpool Victoria Hospital
Blackpool, FY3 8NR
St James University Hospital
Leeds, LS9 7TF
Leicester Royal Infirmary; Dept. of Medical Oncology
Leicester, LE1 5WW
University College London, Department of Haematology
London, NW1 2PG
Royal Marsden Nhs Trust; Consultant Cancer Physician
London, SW3 6JJ
Christie Hospital; Breast Cancer Research Office
Manchester, M20 4QL
Churchill Hospital; Oxford Cancer and Haematology Centre
Oxford, OX3 7LJ
Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
Canada7 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
British Columbia Cancer Agency
Kelowna, British Columbia, V1Y 5L3
Hopital Maisonneuve- Rosemont; Oncology
Montreal, Quebec, H1T 2M4
Chum Hopital Notre Dame; Centre D'Oncologie
Montreal, Quebec, H2L 4M1
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Saskatoon Cancer Centre; Uni of Saskatoon Campus
Saskatoon, Saskatchewan, S7N 4H4
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, M5G 2M9
France7 sites
Institut de Cancerologie de l'Ouest
Angers, 49933
CHU Clermont Ferrand - Hôpital d'Estaing
Clermont-Ferrand, 63003
Hopital Henri Mondor
Créteil, 94010
CHU de Dijon - Hopital le Bocage
Dijon, 21000
Centre Jean Bernard
Le Mans, 72015
CHU Montpellier
Montpellier, 34295
Centre Hospitalier Lyon Sud; Hematolgie
Pierre-Bénite, 69495
Belgium3 sites
ZNA Stuivenberg
Antwerp, 2060
AZ Sint Jan
Bruges, 8000
Cliniques Universitaires St-Luc
Brussels, 1200
About this study
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
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.
- Conditions
- Follicular Lymphoma
- Being tested
- Venetoclax, Bendamustine, Rituximab
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Also called GDC-0199, ABT-199
Venetoclax will be administered as per the schedule specified under arm description.
BendamustineDrug
Also called Levact
Bendamustine will be administered as per the schedule specified under arm description.
RituximabDrug
Also called MabThera, Rituxan
Rituximab will be administered as per the schedule specified under arm description.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) | Experimental | 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. Receives: Drug: Venetoclax; Drug: Bendamustine; Drug: Rituximab |
| Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) | Experimental | 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. Receives: Drug: Venetoclax; Drug: Rituximab |
| Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Experimental | 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. Receives: Drug: Venetoclax; Drug: Bendamustine; Drug: Rituximab |
| Chemotherapy-Containing Cohort: Arm C (BR) | Active comparator | 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. Receives: Drug: Bendamustine; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: 6-8 weeks after Cycle 6 Day 1 (PRA) (Cycle length = 28 days)
Secondary outcomes (23)
Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at PRA
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.
Measured: 4-10 weeks after Cycle 6 Day 1 (Cycle length = 28 days)
Percentage of Participants With CMR According to IRC as Per Lugano Classification, Using PET Scan at Year 1
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.
Measured: 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at Year 1
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.
Measured: 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
Percentage of Participants With Complete Response (CR) According to IRC as Per Lugano Classification, Using Computed Tomography (CT) Scan
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.
Measured: 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
Percentage of Participants With CR According to Investigator as Per Lugano Classification, Using CT Scan
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.
Measured: 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
Percentage of Participants With Objective Response (OR) According to IRC as Per Lugano Classification, Using PET Scan
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.
Measured: 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET Scan
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.
Measured: 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
Percentage of Participants With OR According to IRC as Per Lugano Classification, Using CT Scan
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.
Measured: 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using CT Scan
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.
Measured: 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET or CT Scan
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).
Measured: Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)
Duration of Response (DOR) According to Investigator as Per Lugano Classification, Using PET or CT Scan
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.
Measured: From CMR or PMR until disease progression or death due to any cause (assessed up to approximately 2.5 years)
Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan) or Death
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.
Measured: Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)
Progression-Free Survival (PFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan
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.
Measured: Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)
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
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.
Measured: Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years)
Event-Free Survival (EFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan
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.
Measured: Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years)
Percentage of Participants Who Died Due to Any Cause
Measured: Baseline until death due to any cause (assessed up to approximately 2.5 years
Overall Survival (OS)
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.
Measured: Baseline until death due to any cause (assessed up to approximately 2.5 years)
Apparent Clearance (CL) of Venetoclax
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: 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)
Apparent Volume of Distribution (Vd) of Venetoclax
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.
Measured: 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)
Time to Maximum Plasma Concentration (Tmax) of Venetoclax
Measured: 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)
Maximum Plasma Concentration (Cmax) of Venetoclax
Measured: 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-Time Curve From Time 0 to Last Observed Concentration (AUClast) of Venetoclax
Area under the plasma concentration versus time curve from zero to the last measured concentration (AUClast).
Measured: 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-Time Curve From Time 0 to 8 Hours Post Dose (AUC0-8h) of Venetoclax
Area under the plasma concentration versus time curve from time 0 (pre-dose) to 8 hours post dose (AUC0-8h).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study start1 Dec 2014
- Primary completion27 Sep 2016
- Study completion16 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187861
- Sponsor's protocol ID
- BO29337
- Other IDs
- 2014-000576-26, 2014
- Status last verified
- Jun 2019
- First submitted
- 9 Jul 2014
- Last updated
- 5 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Zinzani PL, Flinn IW, Yuen SLS, Topp MS, Rusconi C, Fleury I, Le Du K, Arthur C, Pro B, Gritti G, Crump M, Petrich A, Samineni D, Sinha A, Punnoose EA, Szafer-Glusman E, Spielewoy N, Mobasher M, Humphrey K, Kornacker M, Hiddemann W. Venetoclax-rituximab with or without bendamustine vs bendamustine-rituximab in relapsed/refractory follicular lymphoma. Blood. 2020 Dec 3;136(23):2628-2637. doi: 10.1182/blood.2020005588.
PubMed 32785666
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02187861
- Acronym / sponsor ID
- BO29337
- Conditions
- Follicular Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 27 Sep 2016 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Posted 13 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) | Experimental | Drug: Venetoclax, Drug: Bendamustine, Drug: RituximabParticipants 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. |
| Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) | Experimental | Drug: Venetoclax, Drug: RituximabParticipants 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. |
| Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Experimental | Drug: Venetoclax, Drug: Bendamustine, Drug: RituximabParticipants 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. |
| Chemotherapy-Containing Cohort: Arm C (BR) | Active comparator | Drug: Bendamustine, Drug: RituximabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenetoclaxAlso: GDC-0199, ABT-199Venetoclax will be administered as per the schedule specified under arm description. | Drug | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR), Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) |
| BendamustineAlso: LevactBendamustine will be administered as per the schedule specified under arm description. | Drug | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR), Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) |
| RituximabAlso: MabThera, RituxanRituximab will be administered as per the schedule specified under arm description. | Drug | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR), Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR), Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) |
Primary outcome
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.
23 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
Overall Survival (OS)
Time frame: Baseline until death due to any cause (assessed up to approximately 2.5 years)
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)
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)
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)
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)
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-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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32785666Zinzani PL, Flinn IW, Yuen SLS, Topp MS, Rusconi C, Fleury I, Le Du K, Arthur C, Pro B, Gritti G, Crump M, Petrich A, Samineni D, Sinha A, Punnoose EA, Szafer-Glusman E, Spielewoy N, Mobasher M, Humphrey K, Kornacker M, Hiddemann W. Venetoclax-rituximab with or without bendamustine vs bendamustine-rituximab in relapsed/refractory follicular lymphoma. Blood. 2020 Dec 3;136(23):2628-2637. doi: 10.1182/blood.2020005588.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
71 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venetoclax, Bendamustine and Rituximab in people with Follicular Lymphoma, run by Hoffmann-La Roche at 71 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Australia, Germany, Italy, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02187861, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.