drugset / Trial / NCT00630253

Cytoxan, Fludara, and Antithymocyte Globulin Conditioning Followed By Stem Cell Transplant in Treating Fanconi Anemia

NCT00630253

Phase 1/2 Completed 31 enrolled Masonic Cancer Center, University of Minnesota
Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, before a donor stem cell transplant helps to remove the patient's cells to allow for the transplant cells to take and grow. It also 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 can make an immune response against the body's normal cells. Giving antithymocyte globulin and removing the T cells from the donor cells before transplant and giving cyclosporine before and after transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects of cyclophosphamide, fludarabine, and antithymocyte globulin followed by donor stem cell transplant and to see how well it works in treating patients with Fanconi anemia.

Timeline

Start
2000-02-17
Primary completion
2020-10-10
Completion
2020-10-10

Drugs

EvaluationDrugModalityDoseRoute
Subject ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic 30 mg/kg Intravenous
Subject Cyclophosphamide Other / unclassified 5 mg/kg Intravenous
Subject Fludarabine Small molecule 35 mg/m2 Intravenous
Background Cyclosporine Peptide Intravenous
Background Methylprednisolone Other / unclassified 2 mg/kg Intravenous
Background Mycophenolate Mofetil Small molecule 15 mg/kg Oral
Background filgrastim Protein / enzyme biologic 5 ug/kg Intravenous

Indications