Immune Disorder HSCT Protocol

Running, not enrolling · Phase 2

Conditions studied: Immune Deficiency Disorders, Severe Combined Immunodeficiency, Chronic Granulomatous Disease, X-linked Agammaglobulinemia, Wiskott-Aldrich Syndrome, Hyper-IgM, DiGeorge Syndrome, Chediak-Higashi Syndrome, Common Variable Immune Deficiency, Immune Dysregulatory Disorders, Hemophagocytic Lymphohistiocytosis, IPEX, Autoimmune Lymphoproliferative Syndrome, X-linked Lymphoproliferative Syndrome

In brief

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.

Key facts

Study ID

NCT01821781

Run by

Washington University School of Medicine

People needed

20

Starts

2013-04-29

Expected to finish

2026-04-01

Last updated by the study team

2026-02-19

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• </= 28 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)

You may not qualify if…

• 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

Where it is running

• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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