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ACTIVE NOT RECRUITING
NCT03531736
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Antithymocyte globulin (Rabbit)

ATG (2 mg/kg/d IV on days-8 through -7)

DRUG

fludarabine

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

RADIATION

total body irradiation

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

DRUG

cyclophosphamide

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

DRUG

Rituxan

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

PROCEDURE

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