The hypothesis of the study is double unit umbilical cord blood transplantation in adults will be associated with a one year survival rate of at least 40%.
Who can participate
Age range22 Years – 50 Years
SexALL
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Inclusion Criteria:
* Age 22 - 50 years
* Patients will have one of the following hematological malignancies:
* Acute myelogenous leukemia (AML): Complete first remission (CR1) at high risk for relapse or Complete second remission (CR2)
* Acute lymphoblastic leukemia (ALL): Complete first remission (CR1) at high risk for relapse or Complete second remission (CR2)
* Acute undifferentiated leukemia (AUL) or biphenotypic leukemia: CR1 or CR2
* Myelodysplastic Syndrome (MDS) with one of the following: Low and Intermediate-1 International Prognostic Scoring System (IPSS) score with Life-threatening neutropenia or thrombocytopenia; or Platelet transfusion dependence Intermediate-2 or High IPSS score Therapy-related disease: patient with history of chemotherapy and current evidence of MDS
* Patients with adequate organ function and performance status criteria
* Two Suitable Umbilical Cord Blood Units: a cryopreserved dose of at least 1.5 x 107 TNC/kg. If the unit contains red cells at time of cryopreservation, the cryopreserved dose must be at least 2.0 x 107 TNC/kg. Each unit must be at least 4/6 HLA-A and B antigen, and DRB1 allele matched with the recipient. Each unit must be at least 3/6 HLA-A, B DRB1 antigen matched to each other.
Exclusion Criteria:
* Patient with suitable related donor
* AML, ALL, AUL, biphenotypic leukemia beyond CR2
* AML evolved from myelofibrosis
* Any acute leukemia with:
* Morphologic relapse or persistent disease in the BM
* Active ext…
What they're measuring
1
Measure overall survival of double unit UCBT in adult patients with hematologic malignancies
Timeframe: One year
Trial details
NCT IDNCT00514579
SponsorCenter for International Blood and Marrow Transplant Research