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Immune Disorder HSCT Protocol

Immune Disorder HSCT Protocol

Recruiting
21 years and younger
All
Phase 2
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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.

Eligibility

Inclusion Criteria:

  • </= 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)

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

Study details
    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

NCT01821781

Washington University School of Medicine

26 January 2024

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