Study on HLA-Mismatched Unrelated Donor Stem Cell Transplant with Post-Transplant Cyclophosphamide

Sponsor: Center for International Blood and Marrow Transplant Research

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04904588

Provider View

This clinical trial is exploring a new approach to stem cell transplantation using donors who are not a perfect match, combined with specific medications to prevent complications. The study aims to determine how well this method works for patients with blood cancers.

Patient Parameters

Program Overview

This study is testing a new method of stem cell transplantation for patients with blood cancers, using donors who are not a perfect match. The process involves using medications like cyclophosphamide, tacrolimus, and mycophenolate mofetil to prevent complications after the transplant. The trial will include adults receiving stem cells from peripheral blood and children receiving stem cells from bone marrow, and aims to evaluate the effectiveness of this treatment approach.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 66 years for chemotherapy-based conditioning or up to 61 years for radiation-based conditioning.
  • Must have a partially matched unrelated donor aged under 35 years.
  • Must have a specific type of blood cancer, such as acute leukemia or myelodysplastic syndrome, with certain conditions met regarding cancer cell levels.
  • Must have good heart, kidney, lung, and liver function based on medical tests.
  • Must be in good overall health with a performance status score above 70%.
  • Must be able to provide informed consent or have a legal representative do so.

For children:

  • Aged 1 to 21 years.
  • Must have a partially matched unrelated donor aged under 35 years.
  • Must have a specific type of blood cancer, such as acute leukemia, with certain conditions met regarding cancer cell levels.
  • Must have good heart, kidney, lung, and liver function based on medical tests.
  • Must be in good overall health with a performance status score above 70%.
  • Legal guardian permission required for those under 18, with age-appropriate assent from the child.

Donor Criteria:

  • Must be unrelated and partially matched at specific genetic markers.
  • Aged 18 to 35 years.
  • Must meet medical suitability requirements for donation.
  • Must agree to donate stem cells and provide informed consent.

Exclusion Criteria

  • Availability of a fully matched related or unrelated donor.
  • Inability to provide informed consent or comply with study requirements.
  • Certain medical conditions like severe myelofibrosis or recent stem cell transplants.
  • Active infections or concurrent participation in other clinical trials.
  • Pregnant or breastfeeding women.
  • HIV-positive patients with detectable viral load.

Donor Exclusion:

  • Unwillingness or inability to donate.
  • Presence of specific antibodies against the donor's mismatched genetic markers.

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