Immune Disorder HSCT Protocol

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Alemtuzumab; Fludarabine; Fludarabine phosphate; Melphalan; Thiotepa

Criteria

Inclusion Criteria:

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• 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