Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03135262
Recruitment Status : Recruiting
First Posted : May 1, 2017
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This Phase Ib/II, open-label, multicenter, non-randomized, dose-escalation study will evaluate the safety, efficacy, and pharmacokinetics of obinutuzumab in combination with idasanutlin and venetoclax in participants with R/R FL and obinutuzumab or rituximab in combination with idasanutlin and venetoclax in participants with R/R DLBCL. The study will include an initial dose-escalation phase followed by an expansion phase. The dose-escalation phase is designed to determine the recommended phase II doses (RP2Ds) and regimen for idasanutlin and venetoclax in combination with obinutuzumab for FL participants and in combination with rituximab for DLBCL participants.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Lymphoma, Large B-Cell, Diffuse Drug: Idasanutlin Drug: Obinutuzumab Drug: Venetoclax Drug: Rituximab Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Patients With Relapsed or Refractory Follicular Lymphoma and Obinutuzumab or Rituximab in Combination With Idasanutlin and Venetoclax in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Actual Study Start Date : June 15, 2017
Estimated Primary Completion Date : October 27, 2022
Estimated Study Completion Date : October 27, 2022


Arm Intervention/treatment
Experimental: Dose-Escalation Cohort: FL
Induction Treatment: Participants will receive either Regimen A or Regimen B. Regimen A: Participants will receive either obinutuzumab on Days 1, 8, 15 of Cycle 1 and then on Day 1 of Cycles 2 to 6; idasanutlin and venetoclax on Days 1 to 5 of Cycles 1 to 6 or obinutuzumab on Days 1, 8, 15 on Cycle 1 and then on Day 1 of Cycles 2 to 6; idasanutlin on Days 1 to 5 and venetoclax on Days 1 to 10 of Cycles 1 to 6. Regimen B (in bridging cohort): Participants will receive obinutuzumab alone in Cycle 1 and obinutuzumab with idasanutlin and venetoclax (both at maximum tolerated dose [MTD] established from Regimen A) in Cycles 2 to 6. Post-Induction Treatment (Maintenance Treatment): Participants will receive obinutuzumab every 2 months for 24 months; idasanutlin and venetoclax for 6 months.
Drug: Idasanutlin
Induction Treatment: Idasanutlin tablets will be administered orally once daily at escalated doses (starting dose 100 milligrams [mg], maximum 600 mg). Post-Induction Treatment: The dose and regimen will be determined by the Sponsor after review of all relevant data. The dose for maintenance/consolidation will not exceed the dose the participant received during induction.

Drug: Obinutuzumab
Participants will receive a fixed dose of obinutuzumab, 1000 mg by intravenous (IV) infusion on Days 1, 8 and 15 of Cycle 1 and on Day 1 of each subsequent cycle (Cycles 2 to 6) (each cycle = 28 days) during induction treatment, and on Day 1 of every other month during maintenance treatment (eligible participants with FL only) or during consolidation treatment (eligible participants with DLBCL only).

Drug: Venetoclax
Induction Treatment: Venetoclax tablets will be administered orally once daily at escalated doses (starting dose 200 mg, maximum 800 mg). Post-Induction Treatment: The dose and regimen will be determined by the Sponsor after review of all relevant data. The dose for maintenance/consolidation will not exceed the dose the participant received during induction.

Experimental: Dose-Escalation Cohort: DLBCL
Induction Treatment: Participants will receive either obinutuzumab on Days 1, 8, 15 of Cycle 1 and then on Day 1 of Cycles 2 to 6; idasanutlin and venetoclax on Days 1 to 5 of Cycles 1 to 6 or obinutuzumab on Days 1, 8, 15 on Cycle 1 and then on Day 1 of Cycles 2 to 6; idasanutlin on Days 1 to 5 and venetoclax on Days 1 to 10 of Cycles 1 to 6. In bridging cohort, participants will receive rituximab on Day 1 of Cycles 1 to 6 and idasanutlin and venetoclax (both at MTD) in Cycles 1 to 6. Post-Induction Treatment (Consolidation Treatment): Participants will receive obinutuzumab or rituximab (according to study treatment received in the induction) every 2 months for 6 months; idasanutlin and venetoclax for 6 months.
Drug: Idasanutlin
Induction Treatment: Idasanutlin tablets will be administered orally once daily at escalated doses (starting dose 100 milligrams [mg], maximum 600 mg). Post-Induction Treatment: The dose and regimen will be determined by the Sponsor after review of all relevant data. The dose for maintenance/consolidation will not exceed the dose the participant received during induction.

Drug: Obinutuzumab
Participants will receive a fixed dose of obinutuzumab, 1000 mg by intravenous (IV) infusion on Days 1, 8 and 15 of Cycle 1 and on Day 1 of each subsequent cycle (Cycles 2 to 6) (each cycle = 28 days) during induction treatment, and on Day 1 of every other month during maintenance treatment (eligible participants with FL only) or during consolidation treatment (eligible participants with DLBCL only).

Drug: Venetoclax
Induction Treatment: Venetoclax tablets will be administered orally once daily at escalated doses (starting dose 200 mg, maximum 800 mg). Post-Induction Treatment: The dose and regimen will be determined by the Sponsor after review of all relevant data. The dose for maintenance/consolidation will not exceed the dose the participant received during induction.

Drug: Rituximab
Rituximab will be administered by IV infusion at a dose of 375 milligrams per square meter (mg/m^2) on Day 1 of Cycles 1−6 during induction treatment and on Day 1 of every other month during consolidation treatment.

Experimental: Expansion Cohort: FL
Induction Treatment: Participants will receive idasanutlin and venetoclax at the RP2D of the selected regimen (Regimen A or B) identified during the dose-escalation phase in combination with obinutuzumab. Regimen A: Participants will receive either obinutuzumab on Days 1, 8, 15 of Cycle 1 and then on Day 1 of Cycles 2 to 6; idasanutlin and venetoclax on Days 1 to 5 of Cycles 1 to 6 or obinutuzumab on Days 1, 8, 15 on Cycle 1 and then on Day 1 of Cycles 2 to 6; idasanutlin on Days 1 to 5 and venetoclax on Days 1 to 10 of Cycles 1 to 6. Regimen B (in bridging cohort): Participants will receive obinutuzumab alone in Cycle 1 and obinutuzumab with idasanutlin and venetoclax in Cycles 2 to 6. Post-Induction Treatment (Maintenance Treatment): Participants will receive obinutuzumab every 2 months for 24 months; idasanutlin and venetoclax for 6 months.
Drug: Idasanutlin
Induction Treatment: Idasanutlin tablets will be administered orally once daily at escalated doses (starting dose 100 milligrams [mg], maximum 600 mg). Post-Induction Treatment: The dose and regimen will be determined by the Sponsor after review of all relevant data. The dose for maintenance/consolidation will not exceed the dose the participant received during induction.

Drug: Obinutuzumab
Participants will receive a fixed dose of obinutuzumab, 1000 mg by intravenous (IV) infusion on Days 1, 8 and 15 of Cycle 1 and on Day 1 of each subsequent cycle (Cycles 2 to 6) (each cycle = 28 days) during induction treatment, and on Day 1 of every other month during maintenance treatment (eligible participants with FL only) or during consolidation treatment (eligible participants with DLBCL only).

Drug: Venetoclax
Induction Treatment: Venetoclax tablets will be administered orally once daily at escalated doses (starting dose 200 mg, maximum 800 mg). Post-Induction Treatment: The dose and regimen will be determined by the Sponsor after review of all relevant data. The dose for maintenance/consolidation will not exceed the dose the participant received during induction.

Experimental: Expansion Cohort: DLBCL
Induction Treatment: Participants will receive rituximab on Day 1 of Cycles 1 to 6; idasanutlin and venetoclax (both at RP2D) on Days 1 to 5 of Cycles 1 to 6 or rituximab on Day 1 of Cycles 1 to 6; idasanutlin on Days 1 to 5 and venetoclax on Days 1 to 10 of Cycles 1 to 6. Post-Induction Treatment (Consolidation Treatment): Participants will receive rituximab every 2 months for 6 months; idasanutlin and venetoclax for 6 months.
Drug: Idasanutlin
Induction Treatment: Idasanutlin tablets will be administered orally once daily at escalated doses (starting dose 100 milligrams [mg], maximum 600 mg). Post-Induction Treatment: The dose and regimen will be determined by the Sponsor after review of all relevant data. The dose for maintenance/consolidation will not exceed the dose the participant received during induction.

Drug: Venetoclax
Induction Treatment: Venetoclax tablets will be administered orally once daily at escalated doses (starting dose 200 mg, maximum 800 mg). Post-Induction Treatment: The dose and regimen will be determined by the Sponsor after review of all relevant data. The dose for maintenance/consolidation will not exceed the dose the participant received during induction.

Drug: Rituximab
Rituximab will be administered by IV infusion at a dose of 375 milligrams per square meter (mg/m^2) on Day 1 of Cycles 1−6 during induction treatment and on Day 1 of every other month during consolidation treatment.




Primary Outcome Measures :
  1. RP2D of Idasanutlin When Given in Combination With Obinutuzumab or Rituximab [ Time Frame: Cycle 1 Day 1 up to Cycle 2 Day 28 (each cycle = 28 days) ]
  2. RP2D of Venetoclax When Given in Combination With Obinutuzumab or Rituximab [ Time Frame: Cycle 1 Day 1 up to Cycle 2 Day 28 (each cycle = 28 days) ]
  3. Percentage of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 Day 1 up to Cycle 2 Day 28 (each cycle = 28 days) ]
  4. Percentage of Participants With Adverse Events (AEs) [ Time Frame: From Baseline up to approximately 48 months ]
  5. Percentage of Participants With Complete Response (CR), Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography-Computed Tomography (PET-CT) Scans Using Modified Lugano 2014 Criteria [ Time Frame: At end of Induction (EOI) (within 6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]) ]

Secondary Outcome Measures :
  1. Percentage of Participants With CR, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria [ Time Frame: At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] ]
  2. Percentage of Participants With CR, Determined by the IRC on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria [ Time Frame: At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] ]
  3. Percentage of Participants With CR, Determined by the Investigator on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria [ Time Frame: At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] ]
  4. Percentage of Participants With Objective Response, Determined by the IRC on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria [ Time Frame: At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] ]
  5. Percentage of Participants With Objective Response, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria [ Time Frame: At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] ]
  6. Percentage of Participants With Objective Response, Determined by the IRC on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria [ Time Frame: At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] ]
  7. Percentage of Participants With Objective Response at EOI, Determined by the Investigator on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria [ Time Frame: At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] ]
  8. Percentage of Participants With Objective Response During the Study, Determined by the Investigator on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria [ Time Frame: From Day 1 of Cycle 1 (cycle length = 28 days) up to approximately 48 months ]
  9. Observed Serum Concentration of Obinutuzumab in Participants With FL [ Time Frame: From Day 1 of Cycle 1 (cycle length = 28 days) up to approximately 48 months (detailed timeframe is mentioned in outcome measure description) ]

    Induction: Pre-dose (any time prior to dose on same day) and 30 minutes (min) post-dose on Day 1 of Cycle 1; Pre-dose (within 5 hours [hrs] prior to dose) and 30 min post-dose on Day 1 of Cycles 2, 4 and 6; Post-induction: Pre-dose (within 5 hrs prior to dose) on Day 1 of Months 1, 7, 13, 19; treatment discontinuation visit (up to 2 years); 120 days after last dose; and 1 to 2 years after last dose (up to approximately 48 months).

    Obinutuzumab infusion will be administered at a rate from 0.5 milligrams per kilogram per hour (mg/kg/hour) (maximum 50 milligrams per hour [mg/hour]) to a maximum rate of 400 mg/hour.


  10. Observed Serum Concentration of Obinutuzumab in Participants With DLBCL [ Time Frame: Induction: Pre-dose (any time prior to dose on same day) and 30 min post-dose on Day 1 of Cycle 1; Pre-dose (within 5 hrs prior to dose) and 30 min post-dose on Day 1 of Cycles 2, 4 and 6 (each cycle = 28 days) ]
    Obinutuzumab infusion will be administered at a rate from 0.5 mg/kg/hour (maximum 50 mg/hour) to a maximum rate of 400 mg/hour.

  11. Observed Serum Concentration of Rituximab in Participants With FL [ Time Frame: Induction: Pre-dose (any time prior to dose on same day) on Day 1 of Cycle 1; Pre-dose (within 5 hrs prior to dose) on Day 1 of Cycles 2, 4, 6; 30 min post-dose on Day 1 of Cycles 1 and 6 (each cycle = 28 days) ]
    Rituximab infusion will be administered at a rate from 0.5 mg/kg/hour (maximum 50 mg/hour) to a maximum rate of 400 mg/hour.

  12. Observed Serum Concentration of Rituximab in Participants With DLBCL [ Time Frame: From Day 1 of Cycle 1 (cycle length = 28 days) up to approximately 48 months (detailed timeframe is mentioned in outcome measure description) ]

    Induction: Pre-dose (any time prior to dose on same day) and 30 min post-dose on Day 1 of Cycle 1; Pre-dose (within 5 hrs prior to dose) on Day 1 of Cycles 2, 4; Pre-dose (within 5 hrs prior to dose) and 30 min post-dose on Day 1 of Cycle 6; Post-induction: treatment discontinuation visit (up to 6 months); 120 days after last dose; and 1 to 2 years after last dose (up to approximately 48 months).

    Rituximab infusion will be administered at a rate from 0.5 mg/kg/hour (maximum 50 mg/hour) to a maximum rate of 400 mg/hour.


  13. Observed Plasma Concentration of Idasanutlin in Participants With FL [ Time Frame: From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description) ]
    Regimen A: Induction: Pre-dose (any time prior to dose on same day) and 6 hrs post-dose on Day 1 of Cycle 1; Pre-dose (within 1 hr prior to dose), and 2, 4, 6 hrs post-dose on Day 5 of Cycle 1; Pre-dose (within 1 hr prior to dose) and 6 hrs post-dose on Days 1 and 5 of Cycles 2 and 4 Regimen B: Induction: Pre-dose (any time prior to dose on same day) on Day 1 of Cycle 1; Pre-dose (any time prior to dose on same day) and 6 hrs post-dose on Day 1 of Cycle 2; Pre-dose (within 1 hr prior to dose), and 2, 4, 6 hrs post-dose on Day 5 of Cycle 2; Pre-dose (within 1 hr prior to dose) and 6 hrs post-dose on Days 1 and 5 of Cycle 4

  14. Observed Plasma Concentration of Idasanutlin in Participants With DLBCL [ Time Frame: From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description) ]
    Induction: Pre-dose (any time prior to dose on same day), 6 hrs post-dose on Day 1 of Cycle 1; Pre-dose (within 1 hr prior to dose), 2, 4, 6 hrs post-dose on Day 5 of Cycle 1; Pre-dose (within 1 hr prior to dose), 6 hrs post-dose on Days 1, 5 of Cycles 2, 4 (each cycle = 28 days)

  15. Observed Plasma Concentration of Venetoclax in Participants With FL [ Time Frame: From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description) ]
    Regimen A: Induction: Pre-dose (any time prior to dose on same day) and 6 hrs post-dose on Day 1 of Cycle 1; Pre-dose (within 1 hr prior to dose), and 2, 4, 6 hrs post-dose on Day 5 of Cycle 1; Pre-dose (within 1 hr prior to dose) and 6 hrs post-dose on Days 1 and 5 of Cycles 2 and 4 Regimen B: Induction: Pre-dose (any time prior to dose on same day) on Day 1 of Cycle 1; Pre-dose (any time prior to dose on same day) and 6 hrs post-dose on Day 1 of Cycle 2; Pre-dose (within 1 hr prior to dose), and 2, 4, 6 hrs post-dose on Day 5 of Cycle 2; Pre-dose (within 1 hr prior to dose) and 6 hrs post-dose on Days 1 and 5 of Cycle 4

  16. Observed Plasma Concentration of Venetoclax in Participants With DLBCL [ Time Frame: From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description) ]
    Induction: Pre-dose (any time prior to dose on same day), 6 hrs post-dose on Day 1 of Cycle 1; Pre-dose (within 1 hr prior to dose), 2, 4, 6 hrs post-dose on Day 5 of Cycle 1; Pre-dose (within 1 hr prior to dose), 6 hrs post-dose on Days 1, 5 of Cycles 2, 4 (each cycle = 28 days)



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.


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

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • B-cell lymphoma classified as either of the following: R/R FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-cluster of differentiation 20 (CD20) monoclonal antibody; R/R DLBCL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody in participants who are not eligible for second line combination chemotherapy and autologous stem-cell transplantation, have failed second line combination chemotherapy, or experienced disease progression following autologous stem-cell transplantation
  • Histologically documented CD20-positive lymphoma
  • Fluorodeoxyglucose (FDG)-avid lymphoma (that is [i.e.], PET-positive lymphoma)
  • At least one bi-dimensionally measurable lesion (greater than [>] 1.5 centimeters [cm] in its largest dimension by CT scan or magnetic resonance imaging [MRI])
  • Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of FL or DLBCL

Exclusion Criteria:

  • Known CD20-negative status at relapse or progression
  • Prior allogeneic stem-cell transplantation (SCT)
  • Completion of autologous SCT within 100 days prior to Day 1 of Cycle 1
  • Prior standard or investigational anti-cancer therapy as specified: Radioimmunoconjugate within 12 weeks prior to Day 1 of Cycle 1; Monoclonal antibody or antibody-drug conjugate within 4 weeks prior to Day 1 of Cycle 1; Radiotherapy, chemotherapy, hormonal therapy, or targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
  • Clinically significant toxicity (other than alopecia) from prior therapy that has not resolved to Grade less than or equal to (</=) 2 (according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0) prior to Day 1 of Cycle 1
  • Grade 3b FL
  • History of transformation of indolent disease to DLBCL (expansion-phase only)
  • Central nervous system lymphoma or leptomeningeal infiltration
  • Treatment with systemic corticosteroids >20 mg/day, prednisone or equivalent
  • Clinical conditions requiring treatment with oral or parenteral anticoagulants or antiplatelet agents unless treatment can be discontinued 7 days (or 5 half-lives) prior to initiation of study treatment (except used as flushes for indwelling catheters)
  • History of severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies
  • Known hypersensitivity or allergy to murine products or any component of the obinutuzumab, rituximab, idasanutlin, or venetoclax formulation
  • Current or history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection: positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or HCV antibody at screening
  • History of progressive multifocal leukoencephalopathy (PML)
  • History of other malignancy that could affect compliance with the protocol or interpretation of results
  • Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results
  • Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by study treatment, such as severe hereditary coagulation disorders or insulin-dependent diabetes mellitus that is not optimally controlled with medical management (example, presence of ketoacidosis)
  • Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1, or anticipation of a major surgical procedure during the study
  • Inadequate hematologic function (unless due to underlying lymphoma), defined as follows: Hemoglobin less than (<) 9 grams per decilitre (g/dL), absolute neutrophil count (ANC) <1.5*10^9 cells per liter (cells/L), platelet count <75*10^9 cells/L
  • Any of the following abnormal laboratory values (unless due to underlying lymphoma): International normalized ratio (INR) or prothrombin time (PT) >1.5*upper limit of normal (ULN) in the absence of therapeutic anticoagulation; partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) >1.5*ULN in the absence of a lupus anticoagulant
  • Life expectancy <3 months

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): NCT03135262


Contacts
Layout table for location contacts
Contact: Reference Study ID Number: BH39147 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
Layout table for location information
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045-2517
United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
United States, Kentucky
Norton Cancer Institute - Dutchmans Recruiting
Louisville, Kentucky, United States, 40207
United States, New York
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
United States, Pennsylvania
Allegheny General Hospital Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15212
Guthrie Clinic Recruiting
Sayre, Pennsylvania, United States, 18840
United States, Virginia
Virginia Commonwealth University - Massey Cancer Center Withdrawn
Richmond, Virginia, United States, 23298
United States, Washington
Swedish Cancer Inst. Completed
Seattle, Washington, United States, 98104
Australia, New South Wales
Prince of Wales Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Australia, Western Australia
Linear Clinical Research Limited Recruiting
Nedlands, Western Australia, Australia, 6009
Germany
Klinikum Augsburg Recruiting
Augsburg, Germany, 86156
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden Recruiting
Dresden, Germany, 01307
SLK-Kliniken Heilbronn GmbH Recruiting
Heilbronn, Germany, 74078
Klinikum Kassel; Klinik für Onkologie und Hämatologie Recruiting
Kassel, Germany, 34125
Universitätsklinikum Köln Recruiting
Köln, Germany, 50937
Klinikum rechts der Isar der TU München Recruiting
München, Germany, 81675
Universitätsklinikum Würzburg; Studienzentrale Hämatologie/Onkologie Recruiting
Würzburg, Germany, 97080
Korea, Republic of
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 41931
National Cancer Center Recruiting
Gyeonggi-do, Korea, Republic of, 10408
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center - Oncology Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 6351
New Zealand
Christchurch Hospital Recruiting
Christchurch, New Zealand, 8011
Auckland Clinical Studies Limited Recruiting
Grafton, New Zealand, 1010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03135262     History of Changes
Other Study ID Numbers: BH39147
2016-002480-34 ( EudraCT Number )
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Venetoclax
Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Obinutuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents