Status:
ACTIVE_NOT_RECRUITING
Haploidentical Hematopoietic Cell Transplantation for Children With Hematologic Malignancies and Myelodysplasia
Lead Sponsor:
Nationwide Children's Hospital
Conditions:
Myelodysplasia
Hematologic Malignancy
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase I/II study designed to evaluate the kinetics of hematopoietic reconstitution and the incidence of acute chronic GVHD after partially matched related donor hematopoietic cell transplant...
Detailed Description
Less than 30% of patients undergoing hematopoietic cell transplantation (HCT) will have an HLA-matched sibling donor. There is a high likelihood of being unable to identify a perfect HLA matched unrel...
Eligibility Criteria
Inclusion
- Patient lacks an HLA matched sibling donor.
- Meets criteria nonhematopoietic organ function according to NCH BMT SOP09.
- If subjects have received a first HCT, they must be eligible for a second HCT if their disease has recurred.
- High resolution HLA and KIR typing
- The subject cannot have an active untreated infection. Viremia by PCR analysis is not considered an active infection but may require immediate viral prophylaxis. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti- fungal therapy and be asymptomatic.
- Negative pregnancy test for females ≥11 years of age or post- menarche.
- Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the Investigator. (Non-childbearing potential defined as pre-menarche, greater than one year post-menopausal or surgically sterilized).
- Subjects must be ≤30 years at the time of consent.
- Signed consent by parent/guardian and assent if appropriate for subjects \< 18 years of age. Signed consent by patient/subject if ≥18 years of age.
Exclusion
- Patient does not have a suitable donor who is willing and able (meets donor criteria).
- Patient has donor-specific anti-HLA antibodies at the time of enrollment
- Patient reports a history of allergic reactions to murine protein
- Donor Eligibility:
- The donor must be ≥18 years of age at the time of the informed consent conference.
- The donor must be a related donor
- The donor will be evaluated according to the current NCH BMT SOP 04 and must meet all criteria.
- The donor must be able and willing to undergo G-CSF mobilization and stem cell apheresis.
- The patient does not have donor specific anti-HLA antibodies
Key Trial Info
Start Date :
March 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03431090
Start Date
March 2 2018
End Date
January 1 2026
Last Update
May 13 2025
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205