Optimized Cord Blood Transplant for Treating High-Risk Blood Cancers After Relapse from First Stem Cell Transplant

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06807606

Provider View

This study is exploring whether a cord blood transplant, following a specific preparation treatment, can help control high-risk blood cancers in patients who need a second stem cell transplant after their first one has relapsed.

Patient Parameters

Program Overview

The aim of this clinical trial is to find out if using a cord blood transplant, after a moderate-intensity preparation treatment, can help manage high-risk blood cancers in patients who have relapsed after their first stem cell transplant. The study will look at survival rates one year after the transplant and other factors like how quickly blood cells recover and the chances of complications.

Description

The main goal of this study is to see how many patients survive one year after receiving a cord blood transplant with a moderate-intensity preparation treatment. Researchers will also look at how quickly and successfully blood cells recover after the transplant, and the chances of the transplant not working. They will monitor for complications like graft-versus-host disease (GVHD) and track survival rates over one, two, and three years. The study will also include lab tests to understand how the transplant affects leukemia.

Eligibility Criteria

Inclusion Criteria

  • Patients aged 0-60 years old.
  • Must have relapsed more than 100 days after their first transplant.
  • Diagnosed with certain types of blood cancers, such as:
    • Acute myelogenous leukemia (AML) in remission.
    • Acute lymphoblastic leukemia (ALL) with less than 5% cancer cells.
    • Other acute leukemias with less than 5% cancer cells.
    • Myelodysplastic Syndromes (MDS) or CMML without severe bone marrow scarring.
  • Must have had one previous stem cell transplant.
  • Good overall health with a Karnofsky score of 70% or higher.
  • Adequate kidney and liver function.
  • Good lung and heart function.
  • Specific criteria for selecting cord blood units for transplant.

Exclusion Criteria

  • Diagnosis of myelofibrosis or other cancers with severe bone marrow scarring.
  • Have had two previous stem cell transplants.
  • Previous radiation therapy that prevents safe delivery of the required radiation dose.
  • Active, uncontrolled infections or GVHD at the time of transplant.
  • Pregnant or breastfeeding women.
  • Unable to give informed consent or follow the study protocol.
  • Women and men must agree to use effective birth control during the study and for a period after treatment to prevent pregnancy.
  • Patients with psychiatric or social issues that would prevent them from following the study requirements.

Locations

FACILITYZIPCITYSTATE
The University of Texas M. D. Anderson Cancer Center77030HoustonTexas

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