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Reduced Intensity Double Umbilical Cord Blood Transplantation

Status: Recruiting
Phase: Phase 2
Diagnosis: Leukemia/MDS
NCT 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 Hospital
David Avigan, MD, Beth Israel Deaconess Medical Center

Contacts:
Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Hematologic malignancy for whom allogeneic stem cell transplantation is deemed clinically appropriate - Appropriate candidate for reduced intensity regimen, according to the treating physician - Lack of 6/6/ or 5/6 HLA-matched related, 8/8/ HLA-matched unrelated donor, or unrelated donor not available with a time frame necessary to perform a potentially curative stem cell transplant - Able to comply with the requirements for care after allogeneic stem cell transplantation Exclusion Criteria: - Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction - Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease - Renal disease - Hepatic disease - Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation - HIV-positive - Uncontrolled infection - Pregnant or breast-feeding
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