Blood and Lymph Conditions

All Conditions

Neoplasms

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Anemia, Aplastic

Hematologic Diseases

Bone Marrow Failure Disorders

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Bone Marrow Diseases

Aplastic Anemia

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Rituximab

Antilymphocyte Serum

Thymoglobulin

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Transplant conditioning will consist of: ATG (2 mg/kg/day IV on days-8 through-6), fludarabine (30 mg/m\^2/d on days -5 through -2), TBI 400 cGy in 2 divided doses (days -2 and -1) and high dose cyclophosphamide given post stem cell infusion (50 mg/kg on days +3 and +4). One dose of Rituxan (200 mg/m\^2) will be given to reduce the risk of EBV viremia. The donor stem cell product will be derived from the peripheral blood with a target cell infusion of ≥8X10\^6 CD34 cells per recipient kg. Patients will receive post-transplant G-CSF starting on day +7. Patients will undergo donor/recipient bone marrow and peripheral chimerism studies at 30 and 100, and 6, 12, 18 and 24 months post allo HCT and thereafter, at the discretion of the treating clinician. Immune function and disease restaging will be performed at day 100 and 6, 12, 18, and 24 months and as otherwise clinically indicated by the treating physician.

Antithymocyte globulin (Rabbit)

fludarabine (30 mg/m2/d on days -5 through -2)

fludarabine

TBI 200 cGy (days -2 and -1) given post stem cell infusion

total body irradiation

cyclophosphamide given post stem cell infusion (50 mg/kg on days +3 and +4)

cyclophosphamide

Rituxan (200 mg/m2) will be given to reduce the risk of EBV viremia

Rituxan

Allogeneic Hematopoietic Stem Cell Transplantation

Roni Tamari, MD

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.

This is a pilot study to assess engraftment of a T cell depleted (TCD) graft following a reduced intensity conditioning regimen (RIC). The conditioning regimen will include total body irradiation (TBI), Fludarabine, anti-thymocyte globulin (ATG) and post transplant cyclophosphamide (PT-Cy). The graft will be TCD and will be composed of a TCR-α/β+ lymphocyte depletion stem cells and CD34+ selected stem cells.

T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia

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

Neutrophil engraftment (recovery of ANC) defined by an ANC ≥ 500/mm\^3 for 3 consecutive days

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia	NCT03531736	Myeloid Disease...	Antithymocyte g... fludarabine total body irra... cyclophosphamid... Rituxan Allogeneic Hema...	18 Years -	Memorial Sloan Kettering Cancer Center
T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia	NCT03531736	Myeloid Disease...	Antithymocyte g... fludarabine total body irra... cyclophosphamid... Rituxan Allogeneic Hema...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for myeloid diseases