CSIDE: A Phase II Trial Comparing Low and Moderate Busulfan Doses in Infants with Severe Combined Immunodeficiency (SCID) Undergoing TCRαβ+/CD19+ Depleted Transplant, by the PIDTC and PBMTC
Phase: Recruiting
First Posted: October
Condition(s): Severe Combined Immunodeficiency (SCID)
NCT Number: NCT03619551 Other Study ID Number(s): PBMTC NMD1801
What Is the Purpose of This Study?
To study if lower doses of chemotherapy will help babies with severe combined immunodeficiency (SCID) to achieve good immunity with less short and long-term risks of complications after transplantation.
Who Can Take Part in This Study?
- Infants with SCID, either typical or leaky or Omenn syndrome.
- Are 0 to 2 years old.
For a full list of eligibility requirements, visit https://clinicaltrials.gov/study/NCT03619551
What Will Happen During This Study?
- Patients will be in the study for up to 3 years.
- They will be admitted to the hospital for chemotherapy, during the transplant, and after the transplant until the doctor feels it is safe for them to go home.
- Patients will have study visits before transplant, during transplant, and days 7, 14, 42, 100, 180, and 365, and year 2 and 3 after transplant.
- Blood will be collected at these visits for research.
Principal Investigator
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