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T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia
Sponsor: Memorial Sloan Kettering Cancer Center
Summary
The main purpose of this study is to learn if a new combination of chemotherapy, in combination with low-dose radiation, will be safe for the patient, and at the same time provide the best opportunity to cure the bone marrow cancer. The combination of chemotherapy and radiation described in the study is considered 'low intensity.' Although the chemotherapy agents used in this study and for transplant are FDA approved, the chemotherapy treatment and conditioning regimens or combinations listed in this consent are not yet FDA approved. The CliniMACS device is FDA approved for one type of T cell depletion (positive selection of the stem cells) but not approved yet for other type of T cell depletion, which is being studied on this protocol. This pilot study, along with other studies will serve as the basis for FDA approval, if outcomes are favorable.
Official title: Allogeneic Hematopoietic Stem Cell Transplantation of α/β T-Lymphocyte Depleted Graft Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
17
Start Date
2018-05-09
Completion Date
2026-05
Last Updated
2025-08-19
Healthy Volunteers
No
Conditions
Interventions
Antithymocyte globulin (Rabbit)
ATG (2 mg/kg/d IV on days-8 through -7)
fludarabine
fludarabine (30 mg/m2/d on days -5 through -2)
total body irradiation
TBI 200 cGy (days -2 and -1) given post stem cell infusion
cyclophosphamide
cyclophosphamide given post stem cell infusion (50 mg/kg on days +3 and +4)
Rituxan
Rituxan (200 mg/m2) will be given to reduce the risk of EBV viremia
Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell Transplantation
Locations (2)
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States