Status:
TERMINATED
Haploidentical Transplant for People With Chronic Granulomatous Disease Using Post Transplant Cyclophosphamide
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Chronic Granulomatous Disease
Eligibility:
All Genders
2-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: \- Chronic Granulomatous Disease (CGD) causes immune system problems. Treatment is usually a bone marrow transplant from a fully matched donor. Researchers want to try using partially mat...
Detailed Description
Allogeneic transplant using HLA matched donors, both related and unrelated, has proven curative for patients with various immunodeficiencies, including those with ongoing infections. However donor ava...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Must have sufficient complications from underlying disease to warrant undergoing transplantation
- Ages 2 years - 65 years
- No appropriate HLA matched donor (available donor has greater than 1 mismatch or the single mismatch is not at DQ for unrelated donors (including cord blood products), or no available 6 out of 6 HLA matched related donor), or patients who may have an unrelated donor, but whose clinical status is such that the time required to obtain an unrelated donor would be life threatening.
- HLA haploidentical family donor graft available.
- Ability to comprehend and willingness to sign the informed consent or have a parent/guardian consent if the donor is a minor; assent being obtained from minors as appropriate
- Must be HIV negative
- Must not be pregnant (confirmed by a negative serum beta-human chorionic gonadotropin (Beta-hCG) for women of child-bearing potential) or breastfeeding
- Must be able to stay within one hour s travel of the NIH for the first 3 months after transplantation and have a family member or other designated companion to stay with during the post-transplant period.
- Must provide a durable power of attorney for health care decisions to an appropriate adult relative or guardian in accordance to NIH Form-200 NIH Durable Power of Attorney for Health Care Decision Making.
- Where appropriate, subjects must agree to use contraception for 3 months post-transplant
- EXCLUSION CRITERIA:
- Major anticipated illness or organ failure incompatible with survival from Allo-transplant
- Inadequate collection from prospective donors.
Exclusion
Key Trial Info
Start Date :
October 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2019
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02282904
Start Date
October 23 2014
End Date
December 10 2019
Last Update
May 12 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892