Study on Combining Unmodified Haplo-Identical Graft with Cord Blood for Transplant Patients

Sponsor: Case Comprehensive Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06904482

Provider View

This clinical trial is exploring whether using a combination of two types of donor cells can improve survival rates without disease in patients needing a transplant for blood cancers.

Patient Parameters

Program Overview

The study aims to find out if using a combination of cord blood and haplo-identical grafts can help patients with blood cancers who need a transplant but don't have a fully matched donor. This approach may increase the chances of finding a suitable donor, especially for Black, Asian, and Hispanic patients. The trial will use a specific method to prepare and combine these donor cells to see if it is safe and effective in preventing the return of the disease.

Description

Cord blood and haplo-identical grafts are alternative sources for stem cell transplants in patients with blood cancers who don't have a fully matched donor. These sources are especially important for Black, Asian, and Hispanic patients, who have lower chances of finding a match. This study will test a new method of combining these two sources to see if it can safely and effectively prevent the return of cancer. The process involves using a drug called cyclophosphamide after the haplo-identical graft and then adding the cord blood graft. Researchers hope this combination will improve survival without disease progression in high-risk patients.

Eligibility Criteria

Inclusion Criteria

  • Adults over 18 years old with certain blood cancers, such as:
    • Acute myelogenous leukemia (AML) with high-risk features
    • Acute lymphoblastic leukemia (ALL) with high-risk features
    • Myelodysplastic syndromes (MDS) with intermediate to very high risk
  • No suitable fully matched donor available
  • Have specific types of donor cells available:
    • A cord blood unit with a certain cell count
    • A haplo-identical donor with a specific cell count
  • May receive additional treatment for leukemia in the brain or testicles if needed
  • Must understand and agree to the study requirements and sign a consent form

Exclusion Criteria

  • Poor organ function, such as:
    • Low kidney function
    • High liver enzymes or bilirubin
    • Poor lung or heart function
  • Serious ongoing health issues, like infections or heart problems
  • Pregnant or breastfeeding women
  • Any condition that might prevent full participation in the study
  • Allergies to study medications
  • Recent stem cell or CAR-T therapy within the last 6 months

Locations

FACILITYZIPCITYSTATE
Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center44106ClevelandOhio

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.