Study on Fludarabine and Intermediate-dose Radiation with Post-Transplant Cyclophosphamide for Blood Cancers

Sponsor: Hackensack Meridian Health

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07214688

Provider View

This clinical trial is testing a new treatment approach for patients undergoing stem cell transplants for blood cancers. The study aims to see if a combination of fludarabine, intermediate-dose radiation, and post-transplant cyclophosphamide can improve survival rates one year after the transplant.

Patient Parameters

Program Overview

The Flu-TBI 800 trial is a phase 2 study designed to evaluate if a combination of fludarabine, intermediate-dose total body irradiation (TBI), and post-transplant cyclophosphamide (PTCy) can improve the one-year survival of patients receiving an allogeneic stem cell transplant for blood cancers.

Description

Participants in this study will receive a treatment plan that includes fludarabine, a chemotherapy drug, given daily for five days before the transplant. They will also receive intermediate-dose total body irradiation (TBI) in four sessions over two days. After the transplant, patients will receive cyclophosphamide to help prevent complications, along with other medications to support their recovery. The goal is to see if this treatment combination can improve survival rates one year after the transplant.

Eligibility Criteria

Inclusion Criteria

  • Ages 18-65 years.
  • Diagnosed with certain blood cancers, such as:
    • Acute or chronic myeloid leukemia with specific conditions.
    • Myelodysplastic syndrome with specific conditions.
    • Myeloproliferative neoplasms with specific conditions.
    • Acute lymphoblastic leukemia or lymphoma in complete remission.
  • Eligible for a stem cell transplant.
  • Good overall health with a performance status of 60% or higher.
  • Adequate heart, lung, liver, and kidney function.
  • Use effective contraception if of reproductive potential.
  • Have a suitable donor for the transplant.
  • Able to attend follow-up visits and comply with treatment plans.
  • Able to give informed consent.

Exclusion Criteria

  • High comorbidity index score above 3.
  • Poor overall health with a performance status below 60%.
  • Active infections or other conditions that prevent a stem cell transplant.
  • Unable or unwilling to give informed consent.
  • Previous allogeneic transplant.
  • Unable to comply with follow-up visits and treatment plans.

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