Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases

Recruiting now · Phase 1/Phase 2

Conditions studied: Metabolic Disorders, Hematologic, Immune, or Bone Marrow Disorders, Hemoglobinopathies, Non-malignant Disorders

In brief

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.

Key facts

Study ID

NCT00920972

Run by

Washington University School of Medicine

People needed

220

Starts

2001-12-01

Expected to finish

2031-12-01

Last updated by the study team

2026-03-25

Who can join

Age: any, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stratum 1: Patient must have non-malignant disorder, excluding thalassemia. Must be receiving a 8/8 HLA-matched bone marrow, related or unrelated Stratum 2: Patient must have thalassemia receiving 8/8 HLA-matched bone marrow or 5-8/8 HLA-matched UCB. Related or unrelated.
• Stratum 3: Patient must have a hemoglobinopathy receiving 7/8 HLA-matched bone marrow or 5-8/8 HLA-matched UCB. Related or unrelated.
• Stratum 4: Patient must have a non-malignant disorder (excluding hemoglobinopathy) receiving 7/8 HLA-matched bone marrow or 5-8/8 HLA-matched UCB. Related or unrelated.
• All strata:
• Recipient age < 21 years
• Lansky/Karnofsky >/= 40
• Adequate pulmonary, renal, liver, and other organ function as defined in protocol
• Negative pregnancy test
• Adequate total nucleated cell or CD34+ dose of product as defined in protocol
• If sickle cell, Hemoglobin S <30%

You may not qualify if…

• HIV positive
• Invasive infection
• Pregnancy/lactating

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States (enrolling)
• Children's Hospital of Orange County — Orange, California, United States (enrolling)
• University of California — San Diego, California, United States (enrolling)
• Yale School of Medicine — New Haven, Connecticut, United States (enrolling)
• George Washington University School of Medicine — Washington D.C., District of Columbia, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• Indiana University School of Medicine — Indianapolis, Indiana, United States (enrolling)
• St. Louis University — St Louis, Missouri, United States (enrolling)
• Washington University School of Medicine (in St. Louis) — St Louis, Missouri, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• Children's Mercy — Kansas City, Missouri, United States
• Texas Transplant Institute — San Antonio, Texas, United States
• University of Calgary — Calgary, Canada
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• BC Children's Hospital — Vancouver, British Columbia, Canada
• University of Manitoba — Winnipeg, Manitoba, Canada
• 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
• Nemours Children's Health — Jacksonville, Florida, United States
• University of Pittsburg — Pittsburgh, Pennsylvania, United States
• Miami Children's Hospital — Miami, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States

Full record on ClinicalTrials.gov

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