Phase 2 Study of Epcoritamab with Rituximab-mini CVP for Older or Frail Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06045247

Provider View

This clinical trial is testing whether adding the drug epcoritamab to a standard treatment combination can help control newly diagnosed diffuse large B-cell lymphoma (DLBCL) in older or frail patients, or those who cannot take certain chemotherapy drugs. The study will also look at the safety of this treatment combination.

Patient Parameters

Program Overview

The purpose of this study is to find out if adding epcoritamab to the standard treatment of rituximab, cyclophosphamide, vincristine, and prednisone (R-miniCVP) can better control newly diagnosed diffuse large B-cell lymphoma (DLBCL) in patients who are older, frail, or unable to take certain chemotherapy drugs. The study will also assess the safety of this combination treatment.

Description

This study aims to evaluate the effectiveness of combining epcoritamab with R-miniCVP in treating elderly or frail patients, or those with heart issues, who have not been treated for DLBCL before. The main goal is to see how well this combination works after six cycles of treatment. Researchers will also look at how long patients respond to the treatment, how long they live without the disease getting worse, and their overall survival. Additionally, the study will explore the quality of life for patients receiving this treatment and investigate any biomarkers that might predict how well the treatment works or why it might not work.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have a confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) or related subtypes.
  • Have not received any prior treatment for the current lymphoma.
  • Be unable to take anthracycline-based chemotherapy due to age (80 or older) or being considered unfit or frail based on a geriatric assessment.
  • Have a heart ejection fraction between 30% and 50% and be minimally symptomatic.
  • Have stage II bulky, III, or IV disease.
  • Have a performance status of 2 or less on the ECOG scale, or 3 if due to lymphoma and improves to 2 or less with pre-treatment.
  • Have measurable disease with at least one tumor 1.5 cm or larger.
  • Have adequate organ and bone marrow function as shown by specific blood tests.
  • Agree not to donate blood during the study and for 12 months after the last dose.
  • Sign an informed consent form and understand the study requirements.
  • Women must not be pregnant or breastfeeding and must agree to use effective contraception during the study and for 12 months after.
  • Men must agree to use a barrier method of birth control and not donate sperm during the study and for 12 months after.

Exclusion Criteria

  • Have known central nervous system lymphoma or leptomeningeal disease.
  • Have had another cancer within the past 3 years, except for certain skin or cervical cancers.
  • Have uncontrolled HIV, active hepatitis B or C, or any significant active infection.
  • Have a history of severe allergic reactions to similar treatments.
  • Have significant heart disease or recent heart attack.
  • Have a history of stroke or seizure disorder.
  • Be pregnant or breastfeeding.
  • Have had major surgery within 28 days or minor surgery within 3 days of starting the study.
  • Have a life expectancy of less than 6 months.
  • Have a history of autoimmune disease requiring treatment in the past 2 years.
  • Have a history of pneumonitis requiring steroids or current pneumonitis.

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