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Alkylating agents

Epcoritamab + Rituximab-mini CVP for Lymphoma

Phase 2
Recruiting
Led By Dai Chihara, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ineligible for anthracycline-based cytotoxic chemotherapy due to one or more of the following:
Have no prior systemic treatment for lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion: an average of 1 year
Awards & highlights

Study Summary

This trial tests if adding a drug to existing treatment helps with newly diagnosed DLBCL, and looks at safety too.

Who is the study for?
This trial is for adults with newly diagnosed Diffuse Large B-cell Lymphoma who are unfit or ineligible for certain chemotherapy due to age, heart function, previous treatments, or other health issues. Participants must have adequate organ and marrow function, not be pregnant or breastfeeding, agree to contraception if of childbearing potential, and cannot have HIV/Hepatitis B/C infections or severe allergies to similar drugs.Check my eligibility
What is being tested?
The study tests whether adding Epcoritamab to the R-miniCVP treatment (Rituximab combined with Cyclophosphamide, Vincristine, Prednisone) is effective in controlling DLBCL. It also examines the safety of this drug combination in patients who meet specific health criteria.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as infusion-related symptoms; blood count changes; liver enzyme alterations; fatigue; allergic responses especially in those with a history of severe allergies; and possibly others not listed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I cannot receive anthracycline-based chemotherapy due to specific health reasons.
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I have not received any systemic treatment for lymphoma.
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I am 80 years old or older.
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I am considered frail based on a geriatric assessment.
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My cancer is advanced, beyond early stages.
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I have a cancerous lesion that is large enough to be measured accurately.
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I have been diagnosed with a specific type of large B-cell lymphoma.
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I have had heart-related side effects from cancer treatment.
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My kidneys are functioning well enough, with a creatinine clearance over 45 ml/min.
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I am 18 years old or older.
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My heart condition causes little to no symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion: an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion: an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Design

1Treatment groups
Experimental Treatment
Group I: R-miniCVP+ EpcoritamabExperimental Treatment5 Interventions
Starting on Day 1 of Cycle 2, you will also receive epcoritamab 1 time each week (Days 1, 8, 15, and 22 of each cycle). Epcoritamab is given as an injection under your skin, after you complete your dose of R-miniCVP. You may receive up to 6 cycles of R-miniCVP (Cycles 1-6) and up to 11 cycles of epcoritamab (Cycles 2-12), depending on how the disease responds to treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Prednisone
2014
Completed Phase 4
~2370
Cyclophosphamide
1995
Completed Phase 3
~3770
Vincristine
2003
Completed Phase 4
~2910

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,991 Previous Clinical Trials
1,792,583 Total Patients Enrolled
Dai Chihara, MDPrincipal InvestigatorM.D. Anderson Cancer Center
~27 spots leftby Jul 2028
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