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Alkylating agents

Immunotherapy + Chemotherapy for Lymphoma

Phase 1 & 2
Recruiting
Led By Stephen D. Smith
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with previously untreated diffuse large B cell lymphoma or grade 3B follicular lymphoma (of any stage)
Patients with de novo DLBCL, composite lymphomas, transformed lymphoma with DLBCL histology, discordant presentations, or high grade B-cell lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines immunotherapy and chemotherapy.

Who is the study for?
Adults with untreated diffuse large B-cell lymphoma or grade 3B follicular lymphoma, who have not received prior therapy for lymphoma. Participants must have adequate organ function, no severe allergies to monoclonal antibodies, and agree to use contraception. Excluded are those with certain infections (HIV, Hepatitis B/C), active central nervous system metastases, other progressing cancers requiring treatment, or conditions that could interfere with the trial.Check my eligibility
What is being tested?
The trial is testing a combination of three monoclonal antibodies (tafasitamab, retifanlimab, rituximab) as prephase treatment along with standard CHOP chemotherapy in patients with diffuse large B-cell lymphoma. The goal is to see if this combination can more effectively kill cancer cells than current treatments.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's increased activity such as inflammation in various organs and infusion-related reactions. Chemotherapy may cause nausea, hair loss, fatigue and increase infection risk due to lowered blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not been treated for my advanced lymphoma.
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I have a type of aggressive lymphoma.
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My heart pumps blood effectively.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicity rate
Secondary outcome measures
Overall response rate
Overall survival
Progression-free survival
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (TRR, CHOP)Experimental Treatment14 Interventions
PREPHASE THERAPY: Patients receive tafasitamab IV over 30 minutes on days 1, 8, and 15 of each cycle, rituximab and hyaluronidase human SC on day 1 of each cycle, and retifanlimab IV over 30 minutes on day 8 of each cycle. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. COMBINATION THERAPY: After completion of prephase therapy or if patients progress during prephase therapy, patients receive tafasitamab IV over 30 minutes, retifanlimab IV over 30 minutes, rituximab and hyaluronidase human SC, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 of each cycle. Patients also receive prednisone PO on days 1-5 of each cycle. Treatment repeats every 21 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vincristine
2003
Completed Phase 4
~2910
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Computed Tomography
2017
Completed Phase 2
~2720
Doxorubicin
2012
Completed Phase 3
~7940
Positron Emission Tomography
2008
Completed Phase 2
~2240
Prednisone
2014
Completed Phase 4
~2370
Tafasitamab
2016
Completed Phase 2
~180
Retifanlimab
2018
Completed Phase 2
~320
Cyclophosphamide
1995
Completed Phase 3
~3770
Biospecimen Collection
2004
Completed Phase 2
~1730

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,316 Total Patients Enrolled
Stephen D. SmithPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
2 Previous Clinical Trials
58 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being accepted for this experiment currently?

"According to clinicaltrials.gov, enrollment for this study has closed since it was last updated on October 26th 2022. Although no longer recruiting participants, there are 1776 other medical trials that still have open registration opportunities at the present time."

Answered by AI
~20 spots leftby Jan 2026