Study on Reduced Intensity Bone Marrow Transplant with Partially Matched Donors for Blood Cancers

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT01203722

Provider View

This clinical trial is exploring a new approach to bone marrow transplants using partially matched donors to treat blood cancers. The study aims to find a safe and effective transplant method that reduces the risk of severe complications and improves survival rates.

Patient Parameters

Program Overview

This study is testing a new method of bone marrow transplant (BMT) using donors who are not a perfect match but are partially matched. The goal is to see if this approach can be done safely and effectively for patients with blood cancers who do not have a fully matched donor. The study will look at different ways to prevent complications after the transplant, including using a drug called sirolimus. The main focus is to find a transplant method that has low rates of severe complications and helps patients survive without major issues for at least six months.

Eligibility Criteria

Inclusion Criteria

  • Patients aged 6 months to 75 years.
  • No suitable fully matched bone marrow donor available.
  • No suitable partially matched first-degree relative donor available.
  • Diagnosed with specific types of blood cancers, such as:
    • Acute leukemia in remission or with poor-risk features.
    • Myelodysplastic syndromes (MDS) with poor-risk features.
    • Chronic myeloid leukemia (CML) that is resistant to certain treatments.
    • Other specific blood disorders and lymphomas that have not responded to previous treatments.
  • Must have less than 20% cancer cells in the bone marrow for certain conditions.
  • Recent chemotherapy or bone marrow transplant to reduce the risk of transplant rejection.
  • Adequate heart, liver, and lung function.
  • Good overall health status as measured by specific performance scores.

Exclusion Criteria

  • Not pregnant or breastfeeding.
  • No uncontrolled infections.
  • No previous allogeneic bone marrow transplant (except identical twin transplant).
  • No active cancer in the brain or spinal cord.

Donor Inclusion Criteria:

  • Donors can be unrelated or distant relatives like second-degree relatives or first cousins.
  • Donor and recipient must match at least 5 out of 10 specific genetic markers.
  • Donors must be healthy and meet medical criteria for donation.

Donor Exclusion Criteria:

  • Donor must not be a perfect genetic match to the recipient.
  • Donor must not have previously donated blood products to the recipient.

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