Status:
RECRUITING
Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
St. Louis Children's Hospital
Conditions:
Metabolic Disorders
Hematologic, Immune, or Bone Marrow Disorders
Eligibility:
All Genders
Up to 20 years
Phase:
PHASE1
PHASE2
Brief 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 cel...
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 disord...
Eligibility Criteria
Inclusion
- 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%
Exclusion
- HIV positive
- Invasive infection
- Pregnancy/lactating
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00920972
Start Date
December 1 2001
End Date
December 1 2031
Last Update
July 22 2024
Active Locations (18)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Children's Hospital of Orange County
Orange, California, United States, 92868
3
University of California
San Diego, California, United States, 92123
4
Yale School of Medicine
New Haven, Connecticut, United States, 06510