Immune Disorder HSCT Protocol



Status:Recruiting
Conditions:Other Indications, Infectious Disease, HIV / AIDS, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases, Other
Healthy:No
Age Range:Any - 21
Updated:3/28/2019
Start Date:March 2013
End Date:March 2024

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

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.


Inclusion Criteria:

-
- Performance status >/= 40

- DLCO >/= 40%

- LVEF >/=40% or LVSF >/=26%

- Serum creatinine < 2x ULN

- Liver enzymes
- 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
We found this trial at
2
sites
San Antonio, Texas 78229
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San Antonio, TX
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Saint Louis, Missouri 63110
Principal Investigator: Jeffrey Bednarski, MD
Phone: 314-454-6018
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Saint Louis, MO
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