Bone Marrow Transplantation in Treating Children With Sickle Cell Disease

Clinical Trial
Study Details
Enrollment
50
Interventions
Name
cyclosporine
Type
Drug
Name
fludarabine
Type
Drug
Name
mycophenolate mofetil
Type
Drug
Name
Bone Marrow Transplantation
Type
Procedure
Phase
Phase 1
Phase 2
Status
COMPLETED
Study ID #
NCT00004485
Study Type
Interventional
Summary

RATIONALE: Sickle cell disease is an inherited disorder in which abnormal, crescent-shaped red blood cells interfere with the ability of the blood to carry oxygen through the body and can cause severe pain, stroke, and organ damage. Bone marrow transplantation, is a procedure in which the soft, sponge-like tissue in the center of bones producing white blood cells, red blood cells, and platelets is replaced by bone marrow from a another person. Bone marrow transplantation may be an effective treatment in relieving the symptoms of sickle cell disease.

PURPOSE: Phase I/II trial to study the effectiveness of bone marrow transplantation in treating children who have sickle cell disease.

Study Overview
Conditions
Description

PROTOCOL OUTLINE: This is a multicenter study. Patients undergo total body irradiation on day 0, followed by allogeneic bone marrow transfusion. Patients also receive fludarabine IV daily and cyclosporine IV twice a day on days -1 to 1. Patients then receive oral cyclosporine on days 1-90, and oral mycophenolate mofetil twice a day on days 0-27.

Patients are followed for 100 days, monthly for 6 months and then annually for 2 years.

Contacts and Locations
Locations
Facility

Children's Hospital of Oakland
Oakland, California 94609
United States

GeoPoint
37.80437, -122.2708
Facility

Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United States

GeoPoint
47.60621, -122.33207