Study on Golcadomide and Rituximab for Treating Relapsed or Resistant Mantle Cell Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT07578077

Provider View

This clinical trial is testing a new treatment combining golcadomide and rituximab for patients with mantle cell lymphoma that has returned or is not responding to treatment. The study aims to find the safest and most effective dose and to see if this combination can better control the cancer.

Patient Parameters

Program Overview

This study is exploring a new treatment for mantle cell lymphoma (MCL) that has either come back after treatment or is not responding to current therapies. The treatment combines golcadomide, which may help stop cancer cells from growing, with rituximab, a drug that helps the immune system target cancer cells. The trial will test the safety, side effects, and best dose of this combination to see if it can effectively treat MCL.

Description

The study is divided into two phases. In Phase I, researchers will determine the safest dose of golcadomide for patients with mantle cell lymphoma (MCL) who have not responded to previous treatments. Patients will take golcadomide by mouth daily for 14 days in each 28-day cycle, for up to 24 cycles, unless the disease progresses or side effects become unacceptable. Blood samples and scans will be taken throughout the trial, and some patients may have a bone marrow or tissue biopsy.

In Phase II, patients will continue to take golcadomide as in Phase I, but will also receive rituximab through an IV on specific days of the treatment cycle. The goal is to see if this combination can improve treatment outcomes for patients with relapsed or resistant MCL. After completing the treatment, patients will be monitored for up to three years to assess the long-term effects and benefits of the therapy.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of mantle cell lymphoma (MCL).
  • The cancer must have returned after treatment or not responded to previous therapies.
  • Must have recovered from previous cancer treatments.
  • Must be able to swallow pills.
  • Must have adequate blood cell counts and organ function.
  • Must not have active infections like HIV or hepatitis.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a period after.
  • Must agree to provide informed consent and follow study procedures.

Exclusion Criteria

  • Recent chemotherapy, radiation, or other cancer treatments within a specified time before starting the study.
  • Use of certain medications that affect the liver or other organs.
  • History of other types of cancer.
  • Unstable heart conditions or recent heart attacks.
  • Known allergies to similar drugs used in the study.
  • Active infections or serious uncontrolled illnesses.
  • Pregnant or breastfeeding women.
  • Any condition that the study doctor believes would make participation unsafe or difficult.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010DuarteCalifornia

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