drugset / Trial / NCT00725062

Donor T Cells in Treating Patients With High-Risk Hematologic Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant

NCT00725062 ↗

Phase 1 Terminated 3 enrolled Masonic Cancer Center, University of Minnesota
Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: A donor peripheral stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of donor T cells may helps stop the patient's immune system from rejecting the donor's stem cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of donor T cells in treating patients with high-risk hematologic cancer who are undergoing donor peripheral blood stem cell transplant. Note: Only Phase I portion of study was performed. Due to slow accrual, study was closed before Phase II portion of study.

Timeline

Start
2008-06
Primary completion
2010-04
Completion
2010-04

Outcome

Outcome not reported

Stopped (Enrollment): “Slow accrual.”

Drugs

EvaluationDrugModalityDoseRoute
Subject CD4+CD25+ regulatory T cells Unknown 3e+06 cells/kg Intravenous
Subject CD4+CD25+ regulatory T cells Unknown 1e+07 cells/kg Intravenous
Subject CD4+CD25+ regulatory T cells Unknown 3e+07 cells/kg Intravenous