Rituximab and Hyaluronidase Human for Diffuse Large B-Cell Lymphoma (DLBCL)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Fred Hutch/University of Washington Cancer Consortium, Seattle, WA
Diffuse Large B-Cell Lymphoma (DLBCL)+5 More
Rituximab and Hyaluronidase Human - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase I/II trial tests the safety of tafasitamab, retifanlimab, and rituximab (TRR) as a prephase treatment and in combination with standard chemotherapy consisting off cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with untreated diffuse large B-cell lymphoma. Tafasitamab, retifanlimab, and rituximab are monoclonal antibodies. Tafasitamab binds to a protein called CD19, which is found on B-cells (a type of white blood cell) and some types of cancer cells. Rituximab binds to a protein called CD20, which is also found on B-cells and some cancer cells. These monoclonal antibodies may help the immune system kill cancer cells. Immunotherapy with other monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as CHOP, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving TRR in combination with CHOP may kill more cancer cells.

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 5 years

Year 5
Overall survival
Week 3
Dose limiting toxicity rate
Year 5
Progression-free survival
Up to 5 years
Overall response rate
Proportion completing prephase
Relative dose intensity of doxorubicin and cylcophosphamide during combination therapy

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Treatment (TRR, CHOP)
1 of 1
Experimental Treatment

35 Total Participants · 1 Treatment Group

Primary Treatment: Rituximab and Hyaluronidase Human · No Placebo Group · Phase 1 & 2

Treatment (TRR, CHOP)Experimental Group · 8 Interventions: Cyclophosphamide, Prednisone, Vincristine, Biopsy, Rituximab and Hyaluronidase Human, Doxorubicin, Retifanlimab, Tafasitamab · Intervention Types: Drug, Drug, Drug, Procedure, Biological, Drug, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~4020
Prednisone
2020
Completed Phase 4
~2450
Vincristine
2003
Completed Phase 4
~2820
Biopsy
2014
Completed Phase 4
~1120
Doxorubicin
2012
Completed Phase 3
~8030
Retifanlimab
2019
Completed Phase 2
~240
Tafasitamab
2016
Completed Phase 2
~30

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Closest Location: Fred Hutch/University of Washington Cancer Consortium · Seattle, WA
Photo of Seattle 1Photo of Seattle 2Photo of Seattle 3
2018First Recorded Clinical Trial
5 TrialsResearching Diffuse Large B-Cell Lymphoma (DLBCL)
139 CompletedClinical Trials

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,570 Previous Clinical Trials
1,567,721 Total Patients Enrolled
Stephen D. SmithPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
2 Previous Clinical Trials
58 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 lymphoma with DLBCL histology, as long as the patient has not received prior therapy for lymphoma.
You have DLBCL in a lymph node and low-grade lymphoma in the bone marrow.
You are willing and able to provide written informed consent/assent for the trial.
You are at least 18 years of age.\n
Platelets > 75,000/mcL.
Have measurable disease, including at least 1 nodal site measuring 1.5 cm or 1 extranodal site measuring 1.

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.