Study on Pralatrexate, Bendamustine, and Total-Body Radiation Followed by Donor Stem Cell Transplant for Treating Relapsed or Resistant T-Cell Non-Hodgkin Lymphoma

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07225985

Provider View

This clinical trial is exploring a new treatment combination for patients with T-cell non-Hodgkin lymphoma that has returned or not responded to previous treatments. The study involves using the drugs pralatrexate and bendamustine, along with total-body radiation, followed by a donor stem cell transplant.

Patient Parameters

Program Overview

The purpose of this study is to find out the best dose and side effects of a new treatment combination for T-cell non-Hodgkin lymphoma that has come back or not responded to other treatments. The treatment includes pralatrexate, which may stop cancer cells from growing, and bendamustine, which may damage cancer cell DNA. Both drugs are given before total-body radiation and a donor stem cell transplant to help kill cancer cells and make room for new healthy cells to grow.

Description

This study is divided into two phases. In the first phase, researchers will determine the safest dose of pralatrexate when combined with bendamustine and total-body radiation. In the second phase, they will expand the study to see how well this combination works.

Participants will receive pralatrexate through an IV for a few minutes on the sixth day before the transplant. Bendamustine will be given through an IV over an hour on the fifth, fourth, and third days before the transplant. Total-body radiation will be administered on the day before or the day of the transplant. After these treatments, participants will receive a stem cell transplant from a donor.

Throughout the study, participants will undergo various tests, including heart scans, lumbar punctures, PET-CT scans, MRIs, bone marrow biopsies, and blood tests. Chest X-rays may also be done if needed. After completing the study treatment, participants will have follow-up visits at 6 months, 1 year, and 2 years to monitor their health and the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with a specific health score, especially those over 60.
  • Diagnosed with T-cell non-Hodgkin lymphoma that has returned or not responded to treatment.
  • May have had previous chemotherapy to manage symptoms before starting the study treatment.
  • Must be in relatively good health with a performance score of 70 or higher.
  • Must have good heart function and no severe heart issues.
  • Must have good liver and lung function as shown by specific tests.
  • Must have good kidney function.
  • May have had a previous stem cell transplant if it was more than 6 months ago.
  • Must have a suitable donor for the stem cell transplant.
  • If previously treated with pralatrexate or bendamustine and responded well, eligibility will be decided by the study leader.
  • Must understand and agree to the study by signing a consent form.
  • Donors must meet specific genetic matching and health criteria.

Exclusion Criteria

  • Active disease in the central nervous system.
  • Other serious illnesses that may limit life expectancy to less than a year.
  • Active infections unless they are being treated and controlled.
  • Allergies or reactions to any study drugs.
  • Pregnant or breastfeeding women.
  • Receiving other cancer treatments at the start of the study.
  • Donors with specific antibodies that may increase the risk of transplant rejection.

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