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MT2019-09: A randomized trial of low versus moderate exposure busulfan for infants with severe combined immunodeficiency (SCID) receiving TCR alpha beta +/CD19+ depleted transplantation: A Phase II study by the Primary Immune Deficiency Treatment Consortium (PIDTC) and Pediatric Blood and Marrow Transplant Consortium (PBMTC) PIDTC CSIDE Protocol
Recruiting
We want to study if lower doses of a chemotherapy drug called busulfan will help babies with SCID achieve good immunity with less short and long-term risks of complications after transplantation. This trial identifies babies with types of immune deficiencies that are most likely to succeed with this approach and offers them transplant early in life before they get severe infections or later if their infections are under control. It includes only patients receiving unrelated or mismatched related donor transplants.
Male or Female
Up to 18 years old
Inclusion Criteria:
• 0 to 2 years old
• infants with SCID, either typical or leaky or Omenn syndrome
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:
• any serious life-threatening or opportunistic infection at time of enrollment
• HIV or HTLV I/II infection
Cancer, Cancer
SCID, Severe Combined Immunodeficiency
Amanda Simmons - simmo743@umn.edu
Christen Ebens
PHASE2
SITE00000541
See this study on ClinicalTrials.gov