drugset / Trial / NCT00782379

Combination Chemotherapy, Donor Stem Cell Transplant, Tacrolimus, Mycophenolate Mofetil, and Cyclophosphamide in Treating Patients With Hematologic Cancer

NCT00782379 ↗

Phase 2 Completed 20 enrolled Northside Hospital, Inc.
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving high-dose cyclophosphamide together with tacrolimus and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well combination chemotherapy works when given together with a donor stem cell transplant, followed by tacrolimus, mycophenolate mofetil, and high-dose cyclophosphamide, in treating patients with high-risk hematologic cancer.

Timeline

Start
2008-10
Primary completion
2011-04
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 110 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 14.5 mg/kg Intravenous
Subject Fludarabine Small molecule 30 mg/m2 Intravenous
Background Mycophenolate Mofetil Small molecule 15 mg/kg Oral
Background Tacrolimus Small molecule 0.03 mg/kg Intravenous