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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion: an average of 1 year

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

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,436 Total Patients Enrolled

Dai Chihara, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

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

Is the administration of R-miniCVP+ Epcoritamab likely to be detrimental for patients?

"Our assessment at Power grades R-miniCVP+ Epcoritamab's safety as a 2 due to the lack of sufficient efficacy data stemming from its Phase 2 trial."

Answered by AI

Are volunteers being recruited for this experiment at the present time?

"The clinical trial's information on clinicaltrials.gov suggests that it is no longer actively recruiting patients, with its original posting being made on March 31st 2024 and the last update occurring on September 19th 2023. However, 1775 other studies are still open to new participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma

2024. "Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06045247.