Status:
RECRUITING
Immune Disorder HSCT Protocol
Lead Sponsor:
Washington University School of Medicine
Conditions:
Immune Deficiency Disorders
Severe Combined Immunodeficiency
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief 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 wi...
Eligibility Criteria
Inclusion
- \</= 28 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01821781
Start Date
March 1 2013
End Date
March 1 2027
Last Update
July 3 2024
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63110