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Status: RecruitingPhase: Phase 2Diagnosis: Leukemia/MDSNCT ID: NCT01408563
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-085
This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells. Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.
Conducting Institutions: Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital
Overall PI: Corey Cutler, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators: Karen Ballen, MD,
Massachusetts General HospitalDavid Avigan, MD,
Beth Israel Deaconess Medical Center
Contacts: Dana-Farber Cancer Institute:
Ilene Galinsky, 617-632-3902,
email@example.comBeth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100