Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases
Start Date
12/1/2001
Completion Date
12/1/2031
Summary
The hypothesis for this study is that a preparative regimen that maximizes host immunosuppression without myeloablation will be well tolerated and sufficient for engraftment of donor hematopoietic cells. It is also to determine major toxicities from these conditioning regimens, within the first 100 days after transplantation.
Detailed Description
The study uses reduced intensity conditioning that is immune suppressive to achieve donor cell engraftment without exposure to radiation or high dose chemotherapy in children with non-malignant disorders. The intent is to minimize early and late regimen related toxicities in the context of a reduced intensity regimen. In addition to maximizing opportunity for donor cell engraftment, the trial seeks to minimize toxicities associated with transplant such as graft versus host disease and employs GVHD prophylaxis that seeks to decrease rates of acute and chronic GVHD in the setting of matched and mismatched donor stem cell transplants from marrow and cord blood sources.
Eligibility Criteria
Age Range: No minimum to 20 years
Interventions
Treatment Plan 1: Stratum 1
Treatment Plan 2: Strata 2, 3, or 4
GVHD Regimen A: UCB Recipients
GVHD Regimen B: BM Recipients
Conditions
Locations
Phoenix Children's Hospital
Phoenix, Arizona 85016
United States
Children's Hospital of Orange County
Orange, California 92868
United States
University of California
San Diego, California 92123
United States
Yale School of Medicine
New Haven, Connecticut 06510
United States
George Washington University School of Medicine
Washington D.C., District of Columbia 20010
United States
Nemours Children's Health
Jacksonville, Florida 32207
United States
University of Miami
Miami, Florida 33136
United States
Miami Children's Hospital
Miami, Florida 33155
United States
All Children's Hospital
St. Petersburg, Florida 33701
United States
Children's Memorial Hospital
Chicago, Illinois 60614
United States
Indiana University School of Medicine
Indianapolis, Indiana 46202
United States
Children's Hospital of New Orleans
New Orleans, Louisiana 70118
United States
Children's Mercy
Kansas City, Missouri 64108
United States
St. Louis University
St Louis, Missouri 63104
United States
Washington University School of Medicine (in St. Louis)
St Louis, Missouri 63110
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Columbia University Medical Center
New York, New York 10032
United States
University of North Carolina
Chapel Hill, North Carolina 27514
United States
Carolinas Medical Center
Charlotte, North Carolina 28232
United States
Duke Children's Hospital
Durham, North Carolina 27705
United States
The University of Oklahoma
Oklahoma City, Oklahoma 73104
United States
University of Pittsburg
Pittsburgh, Pennsylvania 15224
United States
Cook Children's Hospital
Forth Worth, Texas 76104
United States
Texas Transplant Institute
San Antonio, Texas 78229
United States
University of Utah
Salt Lake City, Utah 84132
United States
BC Children's Hospital
Vancouver, British Columbia V6H 3N1
Canada
University of Manitoba
Winnipeg, Manitoba MB R3E 0T4
Canada
University of Calgary
Calgary,
Canada