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Anti-cancer agents
A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
Phase 1 & 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called mosunetuzumab combined with standard chemotherapy and another drug called polatuzumab vedotin. Polatuzumab vedotin is approved for treating certain types of lymphoma that have come back or didn't respond to previous treatments, as well as those who haven't been treated before. The treatment works by helping the immune system find and destroy cancer cells and delivering a poison directly to them.
Eligible Conditions
- Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Phase Ib: Mosunetuzumab (M)-CHOP Dose FindingExperimental Treatment7 Interventions
Participants will receive M-CHOP up to the phase II recommended dose (RP2D).
Group II: Phase Ib: M-CHP-Pola Dose-FindingExperimental Treatment6 Interventions
Participants will receive M-CHP-Pola up to the RP2D.
Group III: Phase II: M-CHP-Pola 1L DLBCLExperimental Treatment6 Interventions
Participants with 1L DLBCL will receive M-CHP-Pola at a dose determined in the dose finding stage.
Group IV: Phase II: M-CHOP Previously Untreated (1L) DLBCL Safety CohortExperimental Treatment6 Interventions
Participants with 1L DLBCL will receive mosunetuzumab at the RP2D in combination with CHOP.
Group V: Phase II: M-CHOP 1L DLBCLExperimental Treatment6 Interventions
Participants with 1L DLBCL will receive M-CHOP at a dose determined in the dose finding stage.
Group VI: Phase II: Rituxumab (R)-CHP-Pola 1L DLBCLActive Control5 Interventions
Participants with 1L DLBCL will receive R-CHP-Pola at a dose determined in the dose finding stage.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Doxorubicin
2012
Completed Phase 3
~8030
Prednisone
2014
Completed Phase 4
~2500
Vincristine
2003
Completed Phase 4
~2970
Tocilizumab
2012
Completed Phase 4
~1840
Cyclophosphamide
2010
Completed Phase 4
~2310
Mosunetuzumab
2019
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,459 Previous Clinical Trials
1,096,927 Total Patients Enrolled
119 Trials studying Lymphoma
25,614 Patients Enrolled for Lymphoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,228 Previous Clinical Trials
895,873 Total Patients Enrolled
96 Trials studying Lymphoma
23,850 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious heart or lung condition.You have moderate or severe peripheral neuropathy.Your IPI score is between 2 and 5.You have had an allogeneic stem cell transplant in the past.You have a history of a disease where your body's immune system attacks itself.You have received treatment before for B-cell non-Hodgkin's lymphoma.You have a serious history of liver disease.You have received an organ transplant in the past.You have B-cell non-Hodgkin lymphoma that has come back or hasn't responded to previous treatments.You have received treatment with a drug that targets CD20 before.You have received treatment with mosunetuzumab in the past.You have not received chemotherapy, immunotherapy, or biologic therapy for at least four weeks before starting the clinical trial.You have had or currently have a disease that affects your brain and nervous system, such as stroke, epilepsy, or neurodegenerative disease.
Research Study Groups:
This trial has the following groups:- Group 1: Phase II: Rituxumab (R)-CHP-Pola 1L DLBCL
- Group 2: Phase Ib: M-CHP-Pola Dose-Finding
- Group 3: Phase II: M-CHOP 1L DLBCL
- Group 4: Phase Ib: Mosunetuzumab (M)-CHOP Dose Finding
- Group 5: Phase II: M-CHOP Previously Untreated (1L) DLBCL Safety Cohort
- Group 6: Phase II: M-CHP-Pola 1L DLBCL
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.