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A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02257567
First received: October 2, 2014
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with standard doses of bendamustine (B) and rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18 weeks for participants with DLBCL and 24 weeks for participants with FL.

Condition Intervention Phase
Lymphoma
Drug: Bendamustine
Drug: Obinutuzumab
Drug: Polatuzumab vedotin
Drug: Rituximab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A PHASE IB/II STUDY EVALUATING THE SAFETY, TOLERABILITY AND ANTI-TUMOR ACTIVITY OF POLATUZUMAB VEDOTIN (DCDS4501A) IN COMBINATION WITH RITUXIMAB (R) OR OBINUTUZUMAB (G) PLUS BENDAMUSTINE (B) IN RELAPSED OR REFRACTORY FOLLICULAR OR DIFFUSE LARGE B-CELL LYMPHOMA

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Phase I: Percentage of Participants with Adverse Events [ Time Frame: From Baseline until up to 90 days after last dose (up to 36 weeks overall) ]
  • Phase II: Percentage of Participants with Complete Response (CR) According to Modified Lugano Criteria as Measured by Positron Emission Tomography (PET) Scan and Determined by Independent Review Committee (IRC) [ Time Frame: 6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 or 28 days) or last dose of study drug (up to 28 weeks overall) ]

Secondary Outcome Measures:
  • Pharmacokinetics: Cmax of Polatuzumab, Bendamustine, and Obinutuzumab in Arms E and F (mg/mL) [ Time Frame: Pre-dose (0 to 4 h) on Day 1 of Cycles 1, 2, 4 and Day 2 of Cycle 1; at EOI on Day 2 of Cycle 1 and Day 1 of Cycles 1, 4; post-dose (1, 2, 3, 4 h) Day 2 of Cycle 1; after last dose (24 weeks); randomly during post-treatment period (up to 2 years overall) ]
  • Pharmacokinetics: Cmax of Bendamustine and Rituximab in Arms B and D (mg/mL) [ Time Frame: Pre-dose (0 to 4 h) on Day 1 of Cycles 1, 2, 4 and Day 2 of Cycle 1; at EOI on Days 1, 2 of Cycle 1; post-dose (1, 2, 3, 4 h) on Day 2 of Cycle 1 (up to 3 months overall) ]
  • Percentage of Participants with CR or PR According to Modified Lugano Criteria as Measured by CT Scan and Determined by IRC and Investigator [ Time Frame: 6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 or 28 days) or last dose of study drug (up to 28 weeks overall) ]
  • Percentage of Participants by Best Objective Response (BOR) According to Modified Lugano Criteria as Measured by PET Scan or CT Scan and Determined by the Investigator [ Time Frame: Baseline, Cycle 3 Day 15, and 6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 or 28 days); then every 3 months for 2 years; thereafter every 6 months until progression or withdrawal (up to about 4.5 years overall) ]
  • Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) [ Time Frame: Every week during treatment (up to 24 weeks) and for the first 2 months after treatment, thereafter every month for 10 months or until withdrawal (up to 18 months overall) ]
  • Pharmacokinetics: Area Under Concentration-Time Curve (AUC) of Polatuzumab, Bendamustine, and Rituximab in Cohort 1A (h*mg/mL) [ Time Frame: Pre-dose (0 to 4 h) and end of infusion (EOI) on Day 2 of Cycle 1 and Day 1 of Cycles 2, 4; on Days 8, 15 of Cycle 1; randomly during post-treatment period (up to 2 years overall) ]
  • Pharmacokinetics: AUC of Polatuzumab, Bendamustine, and Obinutuzumab in Cohort 1B (h*mg/mL) [ Time Frame: Pre-dose (0 to 4 h) on Day 1 of Cycle 1, 2, 4 and Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; at EOI on Day 2 of Cycle 1 and Day 1 of Cycles 2, 4; randomly during post-treatment period (up to 2 years overall) ]
  • Pharmacokinetics: AUC of Polatuzumab, Bendamustine, and Rituximab in Arms A and C (h*mg/mL) [ Time Frame: Pre-dose (0 to 4 h) on Day 1 of Cycles 1, 2, 4; at EOI on Day 2 of Cycle 1 and Day 1 of Cycles 1, 4; post-dose (1, 2, 3, 4 h) on Day 2 of Cycle 1; after last dose (24 weeks); randomly during post-treatment period (up to 2 years overall) ]
  • Pharmacokinetics: AUC of Bendamustine and Rituximab in Arms B and D (h*mg/mL) [ Time Frame: Pre-dose (0 to 4 h) on Day 1 of Cycles 1, 2, 4 and Day 2 of Cycle 1; at EOI on Days 1, 2 of Cycle 1; post-dose (1, 2, 3, 4 h) on Day 2 of Cycle 1 (up to 3 months overall) ]
  • Pharmacokinetics: AUC of Polatuzumab, Bendamustine, and Obinutuzumab in Arms E and F (h*mg/mL) [ Time Frame: Pre-dose (0 to 4 h) on Day 1 of Cycles 1, 2, 4 and Day 2 of Cycle 1; at EOI on Day 2 of Cycle 1 and Day 1 of Cycles 1, 4; post-dose (1, 2, 3, 4 h) Day 2 of Cycle 1; after last dose (24 weeks); randomly during post-treatment period (up to 2 years overall) ]
  • Pharmacokinetics: Maximum Concentration (Cmax) of Polatuzumab, Bendamustine, and Rituximab in Cohort 1A (mg/mL) [ Time Frame: Pre-dose (0 to 4 h) and EOI on Day 2 of Cycle 1 and Day 1 of Cycles 2, 4; on Days 8, 15 of Cycle 1; randomly during post-treatment period (up to 2 years overall) ]
  • Pharmacokinetics: Cmax of Polatuzumab, Bendamustine, and Obinutuzumab in Cohort 1B (mg/mL) [ Time Frame: Pre-dose (0 to 4 h) on Day 1 of Cycle 1, 2, 4 and Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; at EOI on Day 2 of Cycle 1 and Day 1 of Cycles 2, 4; randomly during post-treatment period (up to 2 years overall) ]
  • Pharmacokinetics: Cmax of Polatuzumab, Bendamustine, and Rituximab in Arms A and C (mg/mL) [ Time Frame: Pre-dose (0 to 4 h) on Day 1 of Cycles 1, 2, 4; at EOI on Day 2 of Cycle 1 and Day 1 of Cycles 1, 4; post-dose (1, 2, 3, 4 h) on Day 2 of Cycle 1; after last dose (24 weeks); randomly during post-treatment period (up to 2 years overall) ]
  • Phase II: Percentage of Participants with Adverse Events [ Time Frame: From Baseline until up to 90 days after last dose (up to 36 weeks overall) ]
  • Phase I: Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Polatuzumab in Cohort 1A [ Time Frame: Pre-dose (0 to 4 hours [h]) on Day 2 of Cycle 1; pre-dose (0 to 4 h) on Day 1 of Cycles 2 and 4; randomly during post-treatment period (up to 2 years overall) ]
  • Phase I: Percentage of Participants with ATAs to Polatuzumab and Obinutuzumab in Cohort 1B [ Time Frame: Pre-dose (0 to 4 h) on Day 1 of Cycles 1, 2, 4; pre-dose (0 to 4 h) on Day 2 of Cycle 1; randomly during post-treatment period (up to 2 years overall) ]
  • Phase II: Percentage of Participants with ATAs to Polatuzumab in Arms A and C [ Time Frame: Pre-dose (0 to 4 h) on Day 1 of Cycles 2, 4; pre-dose (0 to 4 h) on Day 2 of Cycle 1; up to 30 days after last dose (approximately 28 weeks); randomly during post-treatment period (up to 2 years overall) ]
  • Phase II: Percentage of Participants with ATAs to Polatuzumab and Obinutuzumab in Arms E and F [ Time Frame: Pre-dose (0 to 4 h) on Day 1 of Cycles 1, 2, 4; pre-dose (0 to 4 h) on Day 2 of Cycle 1; up to 30 days after last dose (approximately 28 weeks); randomly during post-treatment period (up to 2 years overall) ]
  • Percentage of Participants with CR According to Modified Lugano Criteria as Measured by PET Scan and Determined by the Investigator [ Time Frame: 6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 or 28 days) or last dose of study drug (up to 28 weeks overall) ]
  • Percentage of Participants with CR According to Modified Lugano Criteria as Measured by CT Scan and Determined by IRC and Investigator [ Time Frame: 6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 or 28 days) or last dose of study drug (up to 28 weeks overall) ]
  • Percentage of Participants with CR or Partial Response (PR) According to Modified Lugano Criteria as Measured by PET Scan and Determined by IRC and Investigator [ Time Frame: 6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 or 28 days) or last dose of study drug (up to 28 weeks overall) ]

Estimated Enrollment: 224
Study Start Date: October 2014
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (Phase II Randomization): Polatuzumab+BR in FL
Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with FL.
Drug: Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: Treanda; Ribomustin; Levact
Drug: Polatuzumab vedotin
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: DCDS4501A
Drug: Rituximab
Rituximab standard dose, 375 mg/m^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: Rituxan; MabThera
Active Comparator: Arm B (Phase II Randomization): BR in FL
Bendamustine and rituximab will be administered alone (that is, without polatuzumab vedotin) as a control arm in participants with FL.
Drug: Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: Treanda; Ribomustin; Levact
Drug: Rituximab
Rituximab standard dose, 375 mg/m^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: Rituxan; MabThera
Experimental: Arm C (Phase II Randomization): Polatuzumab+BR in DLBCL
Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with DLBCL.
Drug: Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: Treanda; Ribomustin; Levact
Drug: Polatuzumab vedotin
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: DCDS4501A
Drug: Rituximab
Rituximab standard dose, 375 mg/m^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: Rituxan; MabThera
Active Comparator: Arm D (Phase II Randomization): BR in DLBCL
Bendamustine and rituximab will be administered alone (that is, without polatuzumab vedotin) as a control arm in participants with DLBCL.
Drug: Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: Treanda; Ribomustin; Levact
Drug: Rituximab
Rituximab standard dose, 375 mg/m^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: Rituxan; MabThera
Experimental: Arm E (Phase II Expansion): Polatuzumab+BG in FL
Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with FL.
Drug: Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: Treanda; Ribomustin; Levact
Drug: Obinutuzumab
Obinutuzumab 1000 milligrams (mg) IV on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: GA101; Gazyva; Gazyvaro
Drug: Polatuzumab vedotin
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: DCDS4501A
Experimental: Arm F (Phase II Expansion): Polatuzumab+BG in DLBCL
Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with DLBCL.
Drug: Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: Treanda; Ribomustin; Levact
Drug: Obinutuzumab
Obinutuzumab 1000 milligrams (mg) IV on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: GA101; Gazyva; Gazyvaro
Drug: Polatuzumab vedotin
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: DCDS4501A
Experimental: Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in DLBCL
Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with DLBCL for up to 6 cycles.
Drug: Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: Treanda; Ribomustin; Levact
Drug: Polatuzumab vedotin
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: DCDS4501A
Drug: Rituximab
Rituximab standard dose, 375 mg/m^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: Rituxan; MabThera
Experimental: Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in FL
Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with FL for up to 6 cycles.
Drug: Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: Treanda; Ribomustin; Levact
Drug: Polatuzumab vedotin
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: DCDS4501A
Drug: Rituximab
Rituximab standard dose, 375 mg/m^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: Rituxan; MabThera
Experimental: Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in DLBCL
Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with DLBCL for up to 6 cycles.
Drug: Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: Treanda; Ribomustin; Levact
Drug: Obinutuzumab
Obinutuzumab 1000 milligrams (mg) IV on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: GA101; Gazyva; Gazyvaro
Drug: Polatuzumab vedotin
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: DCDS4501A
Experimental: Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in FL
Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with FL for up to 6 cycles.
Drug: Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: Treanda; Ribomustin; Levact
Drug: Obinutuzumab
Obinutuzumab 1000 milligrams (mg) IV on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: GA101; Gazyva; Gazyvaro
Drug: Polatuzumab vedotin
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Other Name: DCDS4501A

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed relapsed or refractory FL (Grades 1, 2, or 3a) or relapsed or refractory DLBCL
  • If the participant has received prior bendamustine, response duration must have been greater than (>) 1 year (for participants who have relapse disease after a prior regimen)
  • At least one bi-dimensionally measurable lesion on imaging scan defined as >1.5 centimeters (cm) in its longest dimension
  • Confirmed availability of archival or freshly collected tumor tissue
  • Life expectancy of at least 24 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Adequate hematological function unless inadequate function is due to underlying disease

Exclusion Criteria:

  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (MAbs, or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
  • Contraindication to bendamustine, rituximab, or obinutuzumab
  • Prior use of any MAb, radioimmunoconjugate, or antibody-drug conjugate (ADC) within 4 weeks or 5 half-lives before Cycle 1 Day 1
  • Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1 Day 1
  • Ongoing corticosteroid use >30 mg per day prednisone or equivalent, for purposes other than lymphoma symptom control
  • Completion of autologous stem cell transplant (SCT) within 100 days prior to Cycle 1 Day 1
  • Prior allogeneic SCT
  • Eligibility for autologous SCT
  • Grade 3b FL
  • History of transformation of indolent disease to DLBCL
  • Primary or secondary CNS lymphoma
  • Current Grade >1 peripheral neuropathy
  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 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 IV antibiotics or hospitalization within 4 weeks prior to Cycle 1 Day 1
  • Suspected or latent tuberculosis
  • Positive test results for chronic hepatitis B virus (HBV) infection or for hepatitis C virus (HCV) antibody
  • Known history of human immunodeficiency virus (HIV) seropositive status or known infection with human T-cell leukemia virus 1 (HTLV-1) virus
  • Women who are pregnant or lactating or who intend to become pregnant within a year of the last dose of study treatment in the rituximab cohort or within 18 months of last dose in the obinutuzumab cohort
  • Evidence of laboratory abnormalities in standard renal, hepatic, or coagulation function tests
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02257567

Contacts
Contact: Reference Study ID Number: GO29365 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

  Show 76 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02257567     History of Changes
Other Study ID Numbers: GO29365
2014-001361-28 ( EudraCT Number )
Study First Received: October 2, 2014
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Lymphoma
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
Obinutuzumab
Rituximab
Bendamustine Hydrochloride
Antibodies, Monoclonal
Immunoconjugates
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on March 28, 2017