Mosunetuzumab for Lymphoma, Follicular, Grade 3b

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MO
Lymphoma, Follicular, Grade 3b+8 More
Mosunetuzumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a two-arm, open-label, phase Ib single-site study with expansion cohorts testing the addition of mosunetuzumab to intensive platinum-based salvage chemotherapy in patients with relapsed/refractory aggressive B cell lymphoma intending to pursue consolidative autoSCT. The hypothesis of this study is that mosunetuzumab can be safely combined with platinum-based salvage chemotherapy in this patient population, and that this approach may outperform chemoimmunotherapy approaches that instead incorporate rituximab retreatment. The enrolling physician's choice of the chemotherapy backbone will determine a patient's assigned study arm (Arm A = DHAX, Arm B = ICE). The two arms will accrue patients to phase Ib and expansion cohorts as well as be analyzed independently.

Eligible Conditions

  • Lymphoma, Follicular, Grade 3b
  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • High Grade B-cell Lymphoma (HGBCL)
  • Transformed B-Cell Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lymphoma, Follicular, Grade 3b

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: At 48 months

Day 42
Number of participants with complete response (CR)
Number of participants with partial response (PR)
Number of participants with progressive disease (PD)
Number of participants with stable disease (SD)
Overall response rate (ORR)
At 48 months
Overall survival (OS)
Progression-free survival (PFS)
Week 13
Frequencies and grades of treatment-emergent adverse events (TEAEs)
Rate of treatment delay or discontinuation due to treatment-emergent adverse events (TEAEs)
Week 9
Number of total tocilizumab doses per participant for management of cytokine release syndrome (CRS)
Percentage of participants requiring tocilizumab for management of cytokine release syndrome (CRS)

Trial Safety

Safety Progress

1 of 3

Other trials for Lymphoma, Follicular, Grade 3b

Trial Design

2 Treatment Groups

Arm A: Mosunetuzumab + DHAX
1 of 2
Arm B: Mosunetuzumab + ICE
1 of 2
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Mosunetuzumab · No Placebo Group · Phase 1

Arm A: Mosunetuzumab + DHAXExperimental Group · 2 Interventions: Mosunetuzumab, DHAX · Intervention Types: Drug, Drug
Arm B: Mosunetuzumab + ICEExperimental Group · 2 Interventions: Mosunetuzumab, ICE · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mosunetuzumab
2020
Completed Phase 1
~30
ICE
2012
Completed Phase 2
~290

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 48 months
Closest Location: Washington University School of Medicine · Saint Louis, MO
Photo of washington university school of medicine 1Photo of washington university school of medicine 2Photo of washington university school of medicine 3
2004First Recorded Clinical Trial
3 TrialsResearching Lymphoma, Follicular, Grade 3b
1465 CompletedClinical Trials

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,772 Previous Clinical Trials
2,269,688 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,482 Previous Clinical Trials
563,305 Total Patients Enrolled
Nancy L Bartlett, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
34 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have received at least one but no more than two prior lines of systemic therapy containing conventional cytotoxic chemotherapy for lymphoma.
You are undergoing autologous stem cell transplantation after platinum-based salvage chemotherapy.
You are at least 18 years of age.
You have a platelet count of at least 75,000/mcL.
You have a hemoglobin level of 8 g/dL or higher.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.