Active — Not RecruitingPhase 2

Alpha/Beta T and CD19+ Depleted Peripheral Stem Cells for Patients With Primary Immunodeficiencies

United States60 participantsStarted 2016-12

Plain-language summary

This is a Phase II trial to determine the ability of a reduced intensity conditioning regimen to allow successful engraftment with alpha/beta T and CD19+ depleted peripheral stem cell grafts from unrelated or partially matched related donors. There are two conditioning regimens depending upon patient diagnosis and age.

Who can participate

Age range25 Years

SexALL

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Inclusion criteria

✓. Ages 0-25 years at time of enrollment
✓. Diseases:
✓. Clinical status
✓. Serum creatinine \<1.5 x upper limit of normal for age Hepatic: ALT \<=250; AST \<=350
✓. Cardiac shortening fraction \>=27%
✓. Bilirubin \<2.5x normal (unless elevation due to Gilberts disease).
✓. No active untreated infection
✓. Signed informed consent

What they're measuring

Event free survival

Timeframe: One year

Stable engraftment

Timeframe: One year

Trial details

NCT IDNCT02990819

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

View on ClinicalTrials.gov More Immunodeficiencies trials