NCT03431090Active, not recruitingPhase 1/2
Haploidentical Hematopoietic Cell Transplantation for Children With Hematologic Malignancies and Myelodysplasia
HAPLEUK17, Haploidentical Hematopoietic Cell Transplantation for Children With Hematologic Malignancies and Myelodysplasia
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
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 transplantation using an αβTCR/CD19+ cell depleted graft.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 27 Dec 2017
- Start date
- 2 Mar 2018
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Nationwide Children's Hospital
- NCT number
- NCT03431090
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 20
- From 2 Mar 2018 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient has donor-specific anti-HLA antibodies at the time of enrollment
- The patient does not have donor specific anti-HLA antibodies
Other illness
- Patient reports a history of allergic reactions to murine protein
- Donor Eligibility:
Age
- The donor must be ≥18 years of age at the time of the informed consent conference.
Other
- Patient does not have a suitable donor who is willing and able (meets donor criteria).
- 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.
Who the study is looking for
- 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.
Age in the registry: - to 30 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.