Study on Golcadomide and Rituximab as a Temporary Treatment for Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT06834373

This clinical trial is exploring whether using golcadomide and rituximab as a temporary treatment can help patients with aggressive B-cell non-Hodgkin lymphoma, which has returned or not responded to previous treatments, to become eligible for CAR T-cell therapy.

Patient Parameters

Program Overview

The purpose of this study is to test if a combination of golcadomide and rituximab can help control aggressive B-cell non-Hodgkin lymphoma that has either come back after treatment or not responded to previous treatments. This temporary treatment, known as bridging therapy, aims to help patients become eligible for CAR T-cell therapy, which has the potential to cure the disease. Golcadomide may help stop cancer cells from growing, while rituximab helps the immune system target and kill cancer cells. By using these drugs before CAR T-cell therapy, the study hopes to improve the chances of patients proceeding to this advanced treatment.

Description

The main goal of this study is to see how well golcadomide and rituximab work together to control aggressive B-cell non-Hodgkin lymphoma. Researchers will measure the disease control rate using scans after two cycles of treatment. They will also look at the overall response rate, safety, and how many patients can move on to CAR T-cell therapy.

Patients will take golcadomide by mouth daily for 14 days and receive rituximab through an IV on specific days during the first cycle. This cycle repeats every 28 days for up to two cycles, unless the disease worsens or side effects become too severe.

If patients are eligible for CAR T-cell therapy after two cycles, they will undergo a procedure to collect white blood cells and may receive additional cycles of golcadomide and rituximab before starting CAR T-cell therapy. If not eligible, patients will continue with golcadomide and rituximab for additional cycles.

Throughout the study, patients will have blood tests and scans to monitor their health and the treatment's effects. After completing the study treatment, patients will have follow-up visits to check their progress.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of aggressive B-cell non-Hodgkin lymphoma that has returned or not responded to previous treatments.
  • Have at least one tumor that can be measured by scans.
  • Be potentially eligible for CAR T-cell therapy.
  • Be in good overall health with a performance status score of 0, 1, or 2.
  • Have adequate blood counts and organ function as determined by specific tests.
  • Women must have two negative pregnancy tests before starting treatment.
  • Agree to return for follow-up visits and not donate blood during the study and for 28 days after the last dose of golcadomide.

Exclusion Criteria

  • Pregnant or nursing women.
  • Individuals who can have children and are not willing to use effective birth control methods.
  • Life expectancy of less than 3 months.
  • Recent treatments with CAR T-cell therapy, certain cancer treatments, or major surgery.
  • Severe heart conditions or other serious illnesses that could interfere with the study.
  • Previous stem cell transplants within a certain timeframe.
  • Active infections or other conditions that weaken the immune system.
  • Current use of certain medications that could interfere with the study.
  • History of blood clots unless willing to take blood thinners during the study.
  • Recent live COVID-19 vaccination.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Arizona85259ScottsdaleArizona
Mayo Clinic in Florida32224-9980JacksonvilleFlorida
Mayo Clinic Health System in Albert Lea56007Albert LeaMinnesota
Mayo Clinic Health Systems-Mankato56001MankatoMinnesota
Mayo Clinic in Rochester55905RochesterMinnesota
Mayo Clinic Health System-Eau Claire Clinic54701Eau ClaireWisconsin
Mayo Clinic Health System-Franciscan Healthcare54601La CrosseWisconsin

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