Study on HLA-Mismatched Unrelated Donor Stem Cell Transplant with Reduced Cyclophosphamide for Graft Versus Host Disease Prevention

Sponsor: Center for International Blood and Marrow Transplant Research

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06001385

Provider View

This clinical trial is exploring whether using a lower dose of a drug called cyclophosphamide after a stem cell transplant from a partially matched donor can reduce infections and still protect against Graft Versus Host Disease (GvHD) in patients with blood cancers.

Patient Parameters

Program Overview

The purpose of this study is to find out if a lower dose of cyclophosphamide, given after a stem cell transplant from a partially matched unrelated donor, can help reduce infections while still providing the same level of protection against Graft Versus Host Disease (GvHD) as the standard dose. This is important for patients with blood cancers who need a transplant but do not have a fully matched donor.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 65 years (or up to 60 years for certain treatments) who can provide informed consent.
  • Willing to follow all study procedures and available for the study duration.
  • Planned to receive a specific type of conditioning treatment before transplant.
  • Have a partially matched unrelated donor aged 18 to 40 years.
  • Diagnosed with certain types of blood cancers, such as acute leukemia or myelodysplastic syndromes, with specific conditions met.
  • Good heart, kidney, lung, and liver function based on medical tests.
  • Able to perform daily activities with a performance score of 60% or higher.

Stratum 2:

  • Adults aged 18 years or older who can provide informed consent.
  • Planned to receive a specific type of conditioning treatment before transplant.
  • Have a partially matched unrelated donor aged 18 to 40 years.
  • Diagnosed with certain types of leukemia or lymphoma, with specific conditions met.
  • Good heart, kidney, lung, and liver function based on medical tests.
  • Able to perform daily activities with a performance score of 60% or higher.

Stratum 3:

  • Adults aged 18 years or older who can provide informed consent.
  • Planned to receive a specific type of conditioning treatment before transplant.
  • Have a partially matched unrelated donor aged 18 to 40 years.
  • Diagnosed with primary myelofibrosis or related conditions, with specific conditions met.
  • Good heart, kidney, lung, and liver function based on medical tests.
  • Able to perform daily activities with a performance score of 60% or higher.

Donor Criteria:

  • Unrelated to the patient and partially matched at specific genetic markers.
  • Aged 18 to 40 years and meet medical suitability for donation.
  • Willing to donate stem cells and able to provide informed consent.

Exclusion Criteria

  • Have a fully matched related or unrelated donor available.
  • Unable to provide informed consent or follow study procedures.
  • Have had a previous allogeneic transplant or a recent autologous transplant.
  • Pregnant or breastfeeding women.
  • Have uncontrolled infections at the time of transplant preparation.
  • Enrolled in another clinical trial for GvHD or infection prevention.
  • Undergoing desensitization to reduce anti-donor antibodies before transplant.
  • HIV positive with a detectable viral load, unless well controlled with treatment.

Donor Exclusion:

  • Unwilling or unable to donate.
  • Recipient has antibodies against the donor's mismatched genetic markers.

Get This Program In Your Inbox

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