A Phase II Study of a Modified Dose of rATG in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant

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Full Title

Phase 2 Study of Personalized r-ATG Dosing to Improve Survival Through Enhanced Immune Reconstitution in Pediatric and Adult Patients Undergoing ex-vivo CD34-Selected Allogeneic-HCT (PRAISE-IR)

Purpose

The purpose of this study is to assess the safety and effectiveness of a personalized dose of a drug called rATG before bone marrow transplantation in children and adults receiving a donated (allogeneic) bone marrow transplant for acute leukemia or myelodysplastic syndromes (MDS).  Conditioning regimens are a standard part of bone marrow transplantation and help make room for donated cells to grow, prevent the body from rejecting donated cells, and kill any cancer cells remaining in the body. In this study, the conditioning regimen consists of two combinations of chemotherapy and possibly total body irradiation.

rATG is a drug that targets and deactivates white blood cells called T cells. T cells normally help protect against infections from harmful bacteria and viruses, but they can also attack the new stem cells the patient receives from a donor. Researchers believe that adjusting the dose of rATG based on a patient’s weight and white blood cell count may help the patient’s immune system recover sooner and prevent transplant-related side effects.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be planning to receive a donated bone marrow transplant as a treatment for acute leukemia (including acute myeloid leukemia and acute lymphocytic leukemia) or myelodysplastic syndromes.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 4 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Kevin Curran at 212-639-5836.

Protocol

21-193

Phase

II

Disease Status

Relapsed or Refractory

Investigator