Immune Disorder HSCT Protocol

  • STATUS
    Recruiting
  • End date
    Mar 11, 2024
  • participants needed
    20
  • sponsor
    Washington University School of Medicine
Updated on 11 May 2022
stem cell transplantation
fludarabine
immunosuppressive
filgrastim
granulocyte colony stimulating factor
melphalan
treatment regimen
immunosuppressive therapy
stem cell infusion
thiotepa
colony stimulating factor
hsct
g-csf
preparative regimen
immunosuppressants
alemtuzumab
immunosuppression
immune disorder
immune suppression

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.

Details
Condition 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
Treatment Transplant preparative regimen of alemtuzumab, fludarabine, thiotepa, and melphalan
Clinical Study IdentifierNCT01821781
SponsorWashington University School of Medicine
Last Modified on11 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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