Study on a Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) for Children and Adults Preparing for a Bone Marrow Transplant

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT04872595

This clinical trial is exploring whether a personalized dose of rabbit ATG can help the immune system recover faster and reduce side effects in children and adults with acute leukemia or myelodysplastic syndrome who are preparing for a bone marrow transplant.

Patient Parameters

Program Overview

The aim of this study is to find out if using a personalized dose of rabbit anti-thymocyte globulin (P-rATG) in the treatment plan can help the immune system recover more quickly and reduce the risk of side effects related to bone marrow transplants. Participants will include children and adults with acute leukemia or myelodysplastic syndrome (MDS) who are getting ready for an allogeneic hematopoietic cell transplant (allo-HCT). The preparation for the transplant will involve r-ATG, one of two chemotherapy combinations, and possibly total body irradiation (TBI).

Eligibility Criteria

Inclusion Criteria

  • Patients receiving their first bone marrow transplant for certain blood cancers, such as:
    • Acute myeloid leukemia (AML) with specific risk features or in certain stages of remission.
    • Acute leukemias of ambiguous lineage in certain stages of remission.
    • Acute lymphoid leukemia (ALL) with high risk of relapse or in certain stages of remission.
    • Myelodysplastic syndromes (MDS) with specific risk factors or genetic changes.
  • Must be able to handle the treatment to reduce cancer cells.
  • Age requirements:
    • Regimen A: 4 to 60 years old
    • Regimen B: No age limit
  • Must have good organ function, including:
    • Liver: Specific limits on bilirubin and liver enzymes.
    • Kidneys: Specific limits on creatinine and kidney function tests.
  • Must have normal heart and lung function.
  • Must be in good overall health, with specific performance status scores.
  • Must be willing to participate and sign a consent form.

Exclusion Criteria

  • Patients with active cancer outside the bone marrow.
  • Patients with active cancer in the central nervous system.
  • Uncontrolled infections at the time of transplant.
  • Previous bone marrow transplant recipients.
  • Patients who test positive for HIV or HTLV.
  • Pregnant or breastfeeding women.
  • Patients not willing to use birth control during the study.
  • Patients or guardians unable to give consent or follow the study protocol.

Donor Inclusion Criteria:

  • Related or unrelated donors who are a perfect match based on specific genetic markers.
  • Must be able to give consent for the donation process.
  • Must meet standard criteria for donating stem cells.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Cancer Center10065New YorkNew York

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