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Cyclophosphamide, Fludarabine, and Total Body Irradiation Followed by the Transplantation of Unrelated Double-Unit Donor Umbilical Cord Blood Grafts for Patients with Hematological Malignancy

[Protocol 06-014]


Full Title :
A MYELOABLATIVE CONDITIONING REGIMEN CONSISTING OF CYCLOPHOSPHAMIDE, FLUDARABINE AND TOTAL BODY IRRADIATION FOLLOWED BY THE TRANSPLANTATION OF UNRELATED DONOR DOUBLE UNIT UMBILICAL CORD BLOOD GRAFTS FOR PATIENTS WITH HEMATOLOGICAL MALIGNANCY
Purpose :

The purpose of this study is to evaluate the effectiveness of giving stem cells from the umbilical cord blood of two newborn infants to patients with hematological cancers that are advanced or at high risk of relapse. Patients will first receive a combination of chemotherapy drugs (cyclophosphamide and fludarabine) and whole-body irradiation to further treat their cancer. The goal of the transplanted stem cells is to repopulate the patient's bone marrow with healthy cells, and create a new donor immune system to protect against relapse.

However, a single donor cord blood transplant may not contain enough cells to ensure recovery of the patient's bone marrow after chemotherapy. Therefore, in this study two cord blood collections will be used to increase the number of cord blood cells patients receive. This approach is called a "double unit" cord blood transplant. A previous study suggests double unit cord blood transplantation may be more effective than a single-cord transplant.

Eligibility :

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

  • Patients must have a confirmed diagnosis of acute myelogenous leukemia, acute lymphoblastic leukemia, acute undifferentiated leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, or non-Hodgkin's lymphoma that is advanced, relapsed, or in remission and at high risk of relapse. (These criteria will differ according to which type of hematological cancer the patient has.)
  • Patients must not have an HLA-matched stem cell donor.
  • Patients must be ages 4 to 50.

For more information and to see if you are eligible for this study, please contact Dr. Juliet Barker at 212-639-3468.

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