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Home > "R" Clinical Trials Conditions > Randomized double cord blood transplant study  Randomized double cord blood transplant study
Randomized double cord blood transplant study
For Condition: Multiple Myeloma,Lymphoma, Non-Hodgkin,Leukemia, Lymphocytic, Acute,Leukemia, Myelocytic, Acute,Leukemia, Myeloid, Chronic
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: This is a prospective, phase II randomized study, to evaluate the transplantation of two unmanipulated cord blood units (“double cord blood” transplant) versus one unmanipulated and one expanded cord blood unit (“expanded cord blood transplant”) in patients with hematologic malignancies following high-dose or nonmyeloablative therapy:
Details: Over the past five years, cord blood (CB) has been investigated clinically as an alternative source of hematopoietic progenitors for allogeneic transplantation of patients lacking an HLA-matched marrow donor. Fewer T-cells and/or less developed T-cells in CB compared to marrow1 allows for the possibility that CB grafts will produce less Graft vs. Host Disease (GVHD), the major cause of morbidity and mortality in the allogeneic transplant setting.2-4 Other potential advantages include the ability to markedly increase the number of allografts available and thus the number of patients who could be transplanted, given the availability and ease of collecting CB from placental veins prior to disposal of the placenta, compared to collecting bone marrow5 or peripheral blood progenitor cells (PBPCs)6 from living donors. This new source of hematopoietic progenitors has allowed CB banks to target collection of units with human leukocyte antigen (HLA) types such as those of minority African American and Hispanic populations, which are under-represented in the National Marrow Donor Program Registry.7
Eligibility:
Study Type: Interventional,Treatment,Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients must have one of the following hematologic malignancies: - Acute Myelogenous Leukemia, Myelodysplastic Syndrome (RAEB-T and RAEB): induction failure, high-risk for relapse first remission (with high-risk cytogenetics), second or third complete remission, or second relapse with less than 10% blasts in the bone marrow and/or peripheral blood. - Acute Lymphoblastic Leukemia: induction failure, first complete remission with Philadelphia chromosome or translocation (4;11), second or third complete remission, or second relapse with less than 10% blasts in the bone marrow and/or peripheral blood. - CML: second chronic phase, accelerated phase or blast crisis with less than 10% blasts in the bone marrow and/or peripheral blood - Multiple Myeloma: Progressive disease after standard therapy or with the 13q23 cytogenetic abnormality (including relapse post autologous hematopoietic stem cell transplant). - Non-Hodgkin's Lymphoma: Induction failures or relapse (including relapse post autologous hematopoietic stem cell transplant). - Hodgkin's Disease: Induction failures or relapse (including relapse post autologous hematopoietic stem cell transplant). - Chronic Lymphocytic Leukemia: Progressive disease following standard therapy
Total Enrollment: 60
Location and Contact Information:
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 770030
United States
Recruiting Elizabeth Shpall 713-792-9537
Additional Information:
Study ID Numbers: ID02-407;
Study Start Date: April 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067002
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Randomized double cord blood transplant study
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