Study on Glofitamab-Based Treatment for People with Diffuse Large B-Cell Lymphoma

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT06765317

This clinical trial is testing a new treatment combination for people with diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), or transformed lymphoma. The study aims to find out if the treatment is effective and has few side effects.

Patient Parameters

Program Overview

The study is exploring a new treatment that combines the drugs glofitamab, polatuzumab, and obinutuzumab with standard chemotherapy (R-miniCHP) to see if it can effectively treat certain types of lymphoma with minimal side effects. Researchers want to know if this combination can help control the disease in people with DLBCL, HGBCL, or transformed lymphoma.

Eligibility Criteria

Inclusion Criteria

  • Aged 65-79 years and considered unfit or frail, or aged 80 years and older at any fitness level.
  • Diagnosed with DLBCL, HGBCL, or transformed lymphoma.
  • No previous systemic treatment for lymphoma, except for short-term prednisone use.
  • Advanced stage of disease (Stage 2 bulky, 3, or 4).
  • Eligible for anthracycline treatment with adequate heart function.
  • At least one measurable tumor by scan.
  • Good overall health with a performance status score of 0 to 2.
  • Adequate blood cell counts and organ function.
  • Negative HIV test, or controlled HIV with stable treatment.
  • Willing to sign informed consent and follow study procedures.
  • Male participants must agree to use contraception and not donate sperm during and after treatment.

Exclusion Criteria

  • Previous systemic treatment for lymphoma.
  • Previous organ or stem cell transplants.
  • Active cancer in the brain or spinal cord.
  • Uncontrolled HIV, hepatitis B, or hepatitis C infections.
  • Active infections or recent major surgery.
  • Significant heart disease or uncontrolled autoimmune disorders.
  • History of certain severe illnesses or conditions that could affect safety.
  • Allergies to study drugs or similar medications.
  • Recent use of certain cancer treatments or investigational therapies.
  • Recent radiotherapy to specific areas.
  • High-dose steroid use for non-lymphoma reasons.
  • History of other cancers that could interfere with the study.
  • Recent live vaccinations or plans to receive them during the study.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (All Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)11553Rockville CentreNew York

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