drugset / Trial / NCT00301834

Alemtuzumab, Fludarabine, and Busulfan Followed By Donor Stem Cell Transplant in Treating Young Patients With Hematologic Disorders

NCT00301834 ↗

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as fludarabine and busulfan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell, bone marrow , or umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine together with methotrexate and methylprednisolone may stop this from happening. PURPOSE: This phase II trial is studying how well giving alemtuzumab together with fludarabine and busulfan works when given before donor stem cell transplant in treating young patients with hematologic disorders.

Timeline

Start
2005-01
Primary completion
2011-09
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Alemtuzumab Monoclonal antibody 0.5 mg/kg Intravenous
Subject Busulfan Small molecule — Intravenous
Subject Fludarabine Small molecule 1.3 mg/kg Intravenous
Subject Fludarabine Small molecule 40 mg/m2 Intravenous
Background Cyclosporine Peptide 3 mg/kg Intravenous
Background Methotrexate Small molecule 10 mg/m2 —
Background Methylprednisolone Other / unclassified — Intravenous