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Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases
Sponsor: Washington University School of Medicine
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.
Official title: A Study of Hematopoietic Stem Cell Transplantation (HSCT) in Non-Malignant Disease Using a Reduced-Intensity Preparatory Regime
Key Details
Gender
All
Age Range
Any - 20 Years
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2001-12
Completion Date
2031-12
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
Treatment Plan 1: Stratum 1
Day -50 to -21: Hydroxyurea 30mg/kg PO q day Day -22: Campath-1H 3 mg IV or SQ... Day -21: Campath-1H 10 mg IV or SQ... Day -20: Campath-1H 15 mg IV or SQ... Day -19: Campath-1H 20 mg IV or SQ... Day -8: Fludarabine 30mg/m2 IV... Day -7: Fludarabine 30mg/m2 IV... Day -6: Fludarabine 30mg/m2 IV... Day -5: Fludarabine 30mg/m2 IV... Day -4: Fludarabine 30mg/m2 IV... Day -3: Melphalan 140 mg/m2 IV... (dose modifications for patients \<10 kgs) Procedure/Surgery: Hematopoietic stem cell infusion on Day 0...
Treatment Plan 2: Strata 2, 3, or 4
Day -50 to -21: Hydroxyurea 30mg/kg PO q day… Day -22: Campath-1H 3 mg IV or SQ... Day -21: Campath-1H 10 mg IV or SQ... Day -20: Campath-1H 15 mg IV or SQ... Day -19: Campath-1H 20 mg IV or SQ... Day -8: Fludarabine 30mg/m2 IV... Day -7: Fludarabine 30mg/m2 IV... Day -6: Fludarabine 30mg/m2 IV... Day -5: Fludarabine 30mg/m2 IV... Day -4: Fludarabine 30mg/m2 IV... Day -4: Thiotepa 8mg/kg IV… Day -3: Melphalan 140 mg/m2 IV... (dose modifications for patients \<10 kgs) Procedure/Surgery: Hematopoietic stem cell infusion on day 0...
GVHD Regimen A: UCB Recipients
Day -3: Begin Tacrolimus or cyclosporine Begin MMF Day -1: Abatacept 10mg/kg IV Day +5: Abatacept 10mg/kg IV Day +14: Abatacept 10mg/kg IV Day +28: Abatacept 10mg/kg IV Day +60: Abatacept 10mg/kg IV Day +100: Abatacept 10mg/kg IV
GVHD Regimen B: BM Recipients
Day -3: Begin Tacrolimus or cyclosporine Begin MMF Day -1: Abatacept 10mg/kg IV Day +1: Methotrexate 7.5mg/m2 IV Day +3: Methotrexate 7.5mg/m2 IV Day +5: Abatacept 10mg/kg IV Day +6: Methotrexate 7.5mg/m2 IV Day +14: Abatacept 10mg/kg IV Day +28: Abatacept 10mg/kg IV Day +60: Abatacept 10mg/kg IV Day +100: Abatacept 10mg/kg IV Day +180: Abatacept 10mg/kg IV Day +270: Abatacept 10mg/kg IV Day +365: Abatacept 10mg/kg IV
Locations (28)
Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital of Orange County
Orange, California, United States
University of California
San Diego, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
George Washington University School of Medicine
Washington D.C., District of Columbia, United States
Nemours Children's Health
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Children's Hospital of New Orleans
New Orleans, Louisiana, United States
Children's Mercy
Kansas City, Missouri, United States
St. Louis University
St Louis, Missouri, United States
Washington University School of Medicine (in St. Louis)
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke Children's Hospital
Durham, North Carolina, United States
The University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Pittsburg
Pittsburgh, Pennsylvania, United States
Cook Children's Hospital
Forth Worth, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
BC Children's Hospital
Vancouver, British Columbia, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
University of Calgary
Calgary, Canada