Clinical trial · Interventional
Haploidentical Hematopoietic Cell Transplantation for Children With Hematologic Malignancies and Myelodysplasia
HAPLEUK17, Haploidentical Hematopoietic Cell Transplantation for Children With Hematologic Malignancies and Myelodysplasia
NCT03431090CI-TRIAL-00107294active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Myelodysplasia | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CliniMACS® TCRαβ/CD19 Combined Depletion System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CliniMACS Isolation
- description
- The mobilized peripheral blood cell collection (apheresis product) will be processed using a Miltenyi CliniMACS device according to the manufacturing instructions. The processing will deplete the αβTCR+ cells and CD19+ cells from the apheresis product to formulate the graft.
- interventionNames
- Device: CliniMACS® TCRαβ/CD19 Combined Depletion System
Primary outcomes (5)
- measure
- Measure rates of neutrophil and platelet engraftment
- timeFrame
- 4 years
- description
- Patients undergoing partially matched related donor hematopoietic cell transplantation with an αβT cell / CD19+ B cell depleted graft should have an improved rate of engraftment.
- measure
- Measure incidence of acute GVHD
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.