drugset / Trial / NCT00914940

Selective Depletion of CD45RA+T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD

NCT00914940

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Allogeneic hematopoietic stem cell transplant (HSCT) is a treatment that can cure acute leukemia and myelodysplasia. After giving the patient chemotherapy and total body irradiation to stop the growth of cancer and remove the patient's diseased bone marrow, healthy stem cells from a donor are infused into the patient to replace the patient's bone marrow and make red and white blood cells and platelets. Unfortunately HSCT is often complicated by 'graft versus host disease' (GVHD) in which the transplanted cells from a donor can make an immune response against the body's normal cells and cause tissue damage and severe symptoms. Removing a subset of the donor T cells, called 'naive T cells', before transplant may reduce the frequency and intensity of GVHD. PURPOSE: This phase II trial will determine whether the removal of the naive T cells from donor cells can decrease the rate and severity of graft-vs-host disease while preserving specific immunity against infections in patients with acute leukemia or advanced myelodysplastic syndromes.

Timeline

Start
2009-12-17
Primary completion
2019-12-01
Completion
2020-05-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Tacrolimus Small molecule 0.03 mg/kg Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous
Background Thiotepa Other / unclassified 5 mg/kg Intravenous