Clinical Trials

 

A Study of Hematopoietic Stem Cell Transplantation (HSCT) in Immune Function Disorders Using a Reduced Intensity Preparatory Regime

Intervention Type: Drug
Study Type: Interventional
Sponsors: Washington University School of Medicine
Participants: 20
Abstract
This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will establish engraftment of donor hematopoietic cells with acceptable early and delayed toxicity in patients with immune function disorders. A regimen that maximizes host immune suppression is expected to reduce graft rejection and optimize donor cell engraftment.
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Facilities
Methodist Heathcare - Recruiting
San Antonio, United States of America
Washington University - Recruiting
Saint Louis, United States of America
Eligibilities
Sex: All
Maximum Age: 21
Healthy Volunteers: No
Inclusion Criteria:
- </= 21 years of age
- Performance status >/= 40
- DLCO >/= 40%
- LVEF >/=40% or LVSF >/=26%
- Serum creatinine < 2x ULN
- Liver enzymes </= 5x ULN
- Negative pregnancy test
- Suitably matched donor (6/6 matched sib UCB, 8/8 matched sib BM or PBSC, 5-6/6 matched unrelated UCB, 7-8/8 matched unrelated BM, double cord)
Exclusion Criteria:
- Known diagnosis of HIV I/II
- Pregnant or breastfeeding
- Uncontrolled invasive fungal or bacterial infections within 1 month prior to starting alemtuzumab
- Uncontrolled viral infection within 1 week prior to starting alemtuzumab

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