Consolidation Mosunetuzumab for Lymphoma, Large B-Cell, Diffuse

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MO
Lymphoma, Large B-Cell, Diffuse+10 More
Mosunetuzumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase 1 pilot study examines the feasibility and safety of mosunetuzumab after autologous stem cell transplant for patients with aggressive B cell lymphomas. Mosunetuzumab is an antibody that has been engineered to attach to two target cells in the immune system: T cells that normally perform tasks like killing virus-infected cells, and cancerous B cells. Mosunetuzumab has been designed to direct these T cells to kill the cancerous B cells instead.

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lymphoma, Large B-Cell, Diffuse

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: At 3 years post-autoSCT (estimated to be 3 years and 7 weeks).

Year 3
Overall survival (OS)
Progression-free survival (PFS)
Year 1
Frequencies and grades of treatment-emergent adverse events (TEAEs)
Rate of treatment discontinuation due to treatment-emergent adverse events (TEAEs)
Week 13
Percentage of consented and enrolled patients completing at least 2 cycles of mosunetuzumab consolidation
Week 58
Number of tocilizumab doses per patient for management of cytokine release syndrome (CRS)
Percentage of patients requiring any tocilizumab doses for management of cytokine release syndrome (CRS)

Trial Safety

Safety Progress

1 of 3

Other trials for Lymphoma, Large B-Cell, Diffuse

Trial Design

1 Treatment Group

Consolidation Mosunetuzumab
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Consolidation Mosunetuzumab · No Placebo Group · Phase 1

Consolidation Mosunetuzumab
Drug
Experimental Group · 1 Intervention: Mosunetuzumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mosunetuzumab
2020
Completed Phase 1
~30

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 3 years post-autosct (estimated to be 3 years and 7 weeks).
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
35 TrialsResearching Lymphoma, Large B-Cell, Diffuse
1465 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Absolute neutrophil count ≥ 500/mcL and without G-CSF use in past 7 days.
You are undergoing autologous stem cell transplantation after multi-agent salvage chemoimmunotherapy.
You are at least 18 years of age.
Absolute neutrophil count ≥ 1,000/mcL without G-CSF use in past 7 days.
Platelets ≥ 75,000/mcL without TPO mimetic use in past 7 days.
Hemoglobin ≥ 8 g/dL without red blood cell transfusion in past 7 days.

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.