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Monoclonal Antibodies

Dose-Escalation Cohort: FL for Non-Hodgkin's 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 every 6 months until disease progression, the start of new anti-lymphoma treatment, or the end of the study, whichever occurs first (approximately 77 months)
Awards & highlights

Study Summary

This study is evaluating whether a combination of drugs can be used to treat people with relapsed or refractory follicular lymphoma.

Eligible Conditions
  • Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to every 6 months until disease progression, the start of new anti-lymphoma treatment, or the end of the study, whichever occurs first (approximately 77 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to every 6 months until disease progression, the start of new anti-lymphoma treatment, or the end of the study, whichever occurs first (approximately 77 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DLBCL Cohorts: Percentage of Participants With AEs and SAEs
FL Cohorts: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants With Dose-Limiting Toxicities (DLTs)
+3 more
Secondary outcome measures
Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Polatuzumab Vedotin
Number of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Observed Plasma Concentration of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (MMAE) (acMMAE)
+13 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Expansion Cohort: FLExperimental Treatment3 Interventions
Participants with relapsed or refractory FL will receive 18 weeks of induction treatment with polatuzumab vedotin and venetoclax at the RP2D identified during the dose-escalation phase, in addition to obinutuzumab. Those who achieve CR, PR, or SD at the EOI will be eligible to receive a 24-month maintenance regimen consisting of 8 months of venetoclax and 24 months of obinutuzumab.
Group II: Expansion Cohort: DLBCLExperimental Treatment3 Interventions
Participants with relapsed or refractory DLBCL will receive 18 weeks of induction treatment. Venetoclax will be administered at the RP2D identified during the dose-escalation phase, in addition to polatuzumab vedotin and rituximab. Those who achieve CR or PR at the EOI will be eligible to receive an 8-month consolidation regimen consisting of venetoclax and rituximab.
Group III: Dose-Escalation Cohort: FLExperimental Treatment3 Interventions
Participants with relapsed or refractory FL will receive 18 weeks of induction treatment with polatuzumab vedotin and venetoclax at escalating doses to identify the recommended Phase 2 dose (RP2D) for polatuzumab vedotin and venetoclax when combined with a fixed dose of obinutuzumab. Those who achieve CR, PR, or SD at the EOI will be eligible to receive a 24-month maintenance regimen consisting of 8 months of venetoclax and 24 months of obinutuzumab.
Group IV: Dose-Escalation Cohort: DLBCLExperimental Treatment3 Interventions
Participants with relapsed or refractory DLBCL will receive 18 weeks of induction treatment. Venetoclax will be administered at escalating doses to identify the RP2D of venetoclax when combined with fixed doses of polatuzumab vedotin and rituximab. Those who achieve CR or PR at the EOI will be eligible to receive an 8-month consolidation regimen consisting of venetoclax and rituximab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2015
Completed Phase 3
~3250
Rituximab
1999
Completed Phase 4
~1880
Venetoclax
2019
Completed Phase 3
~1990
Polatuzumab Vedotin
2019
Completed Phase 2
~820

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,921 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,369 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)
2016. "A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02611323.
~15 spots leftby Apr 2025
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