Mismatched Related vs. Matched Unrelated Donor

A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) Versus HLA-Haploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) With Acute Leukemia or Myelodysplastic Syndrome (MDS)

What's the purpose of the trial?

This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using mismatched related donors (haploidentical \[haplo\]) versus matched unrelated donors (MUD) in treating children, adolescents, and young adults with acute leukemia or myelodysplastic syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy or radiation therapy, which is intended to kill cancer cells that may be resistant to more standard doses of chemotherapy; unfortunately, this also destroys the normal cells in the bone marrow, including stem cells. After the treatment, patients must have a healthy supply of stem cells reintroduced or transplanted. The transplanted cells then reestablish the blood cell production process in the bone marrow. The healthy stem cells may come from the blood or bone marrow of a related or unrelated donor. If patients do not have a matched related donor, doctors do not know what the next best donor choice is or if a haplo related donor or MUD is better. This trial may help researchers understand whether a haplo related donor or a MUD HCT for children with acute leukemia or MDS is better or if there is no difference at all.
Trial status

Accepting patients

Phase
Phase 3
Enrollment
435
Last Updated
1 month ago
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Participating Centers

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Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Allogeneic Stem Cell Transplant is a type of stem cell transplant that utilizes a donor's pre-collected stem cells to rescue the bone marrow from the toxic effects of very high dose chemotherapy.
  • Antithymocyte Globulin (ATG) is an antibody preparation made from rabbits or horses immune cells altered with human thymocytes. ATG is used to prevent or treat acute cellular rejection after solid organ transplantation and as a therapy for certain other blood disorders.
  • Busulfan is a chemotherapy cancer medication that interferes with the growth and spread of cancer cells in the body, and may be used in the treatment of many different cancers.
  • Cyclophosphamide is a chemotherapy agent used in the treatment of cancer.
  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Melphalan is a chemotherapy medication used in the treatment of different cancers.
  • Methotrexate is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Mycophenolate Mofetil is an immunosuppressive medication used to help prevent rejection in patients who have had a transplant.
  • Rituximab is an anti-CD20 monoclonal antibody currently approved for use in B-Cell Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukemia, and several autoimmune conditions.
  • Tacrolimus is an immunosuppressive medication used to help prevent rejection in patients who have had a transplant.
  • Thiotepa is an antineoplastic chemotherapy agent that is used to treat several different kinds of cancer.

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