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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
Status: 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.
Sex: Male or Female
Age Group: 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
Conditions:
Cancer, Cancer
Keywords:
SCID, Severe Combined Immunodeficiency
Study Contact: Amanda Simmons - simmo743@umn.edu
Principal Investigator: Christen Ebens
Phase: PHASE2
IRB Number: SITE00000541
See this study on ClinicalTrials.gov