drugset / Trial / NCT00618540

Reduced Intensity Hematopoietic Cell Transplantation for Patients With Resistant Langerhans Cell Histiocytosis

NCT00618540 ↗

Phase 2 Terminated 1 enrolled Masonic Cancer Center, University of Minnesota
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Giving a monoclonal antibody, such as alemtuzumab, and chemotherapy drugs, such as fludarabine and melphalan, before a donor stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of abnormal 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 cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving alemtuzumab together with fludarabine and melphalan followed by a donor stem cell transplant works in treating young patients with resistant Langerhans cell histiocytosis.

Timeline

Start
2007-01
Primary completion
2013-05
Completion
2013-05

Outcome

Outcome not reported

Stopped (Enrollment): “Slow accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Alemtuzumab Monoclonal antibody 0.2 mg/kg Intravenous
Subject Fludarabine Small molecule 30 mg/m2 Intravenous
Subject Melphalan Small molecule 140 mg/m2 Intravenous