drugset / Trial / NCT03531736

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

NCT03531736

Phase 1 Active not recruiting 17 enrolled Memorial Sloan Kettering Cancer Center
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-05-09
Primary completion
2026-05
Completion
2026-05

Drugs

EvaluationDrugModalityDoseRoute
Background Cyclophosphamide Other / unclassified 50 mg/kg
Background Fludarabine Small molecule 30 mg/m2
Background Rituximab Monoclonal antibody 200 mg/m2
Background Thymoglobulin Protein / enzyme biologic 2 mg/kg Intravenous

Indications