Clinical trial · Interventional
TCDαβ/CD45RA Haploidentical Transplantation in Children With Leukemia
A Multi-center Prospective Clinical Study in China Using CliniMACS TCRα/β+ and CD45RA+ T Cell Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Stem Cell Transplantation in Children With Leukemia
NCT04033627CI-TRIAL-00061126unknownN/AClinicalTrials.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 multi-center clinical study in China using CliniMACS TCRα/β+ and CD45RA+ T cell depleted stem cell grafts from haploidentical donors for hematopoietic stem cell transplantation in children.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Graft-Versus-Host Disease (Gvhd) Grade IV (Diagnosis) | — | UNRESOLVED | — |
| Relapsed Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Relapsed Pediatric AML | Childhood Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| In Vitro T cells depletion using CliniMCAS system | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- In Vitro T cell depletion
- description
- Use the CliniMACS TCRα/β and CD45 Systems to deplete TCRα/β+ and CD45RA+ cells from the mobilized peripheral blood stem cells of a haploidentical donor in patients with leukemia.
- interventionNames
- Procedure: In Vitro T cells depletion using CliniMCAS system
Primary outcomes (2)
- measure
- Log number of In Vitro T cells depletion
- timeFrame
- One week
- description
- Log number of In Vitro T cells depletion using CliniMACS TCRab/CD45RA system.
- measure
- Incidence of grade II-IV acute GVHD
- timeFrame
- up to 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Months
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Pediatric patients with hematological malignancies in complete remission (CR), partial remission (PR) or with stable disease * Acute myeloid leukemia (AML): Patients with high-risk AML in CR1 Patients with relapsed or primary therapy-refractory AML * Acute lymphoid leukemia (ALL): Patients with high-risk ALL in CR1 Patients with relapsed or primary refractory ALL Exclusion Criteria: * Age \>18 years or \<8 weeks * Patients with progressive disease prior HCT * \<3 months after preceding hematopoietic cell transplantation (HCT) * History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukencephalopathy, active CNS infection) * Fungal infections with radiological and clinical progression * Liver function abnormalities with bilirubin \>2 mg/dL and elevation of transaminases higher than 400 U/L * Chronic active viral hepatitis * Ejection fraction \<40% or shortening fraction \<25% on echocardiography * Patients with \> grade II hypertension by Common Toxicity Criteria (CTC) * Creatinine clearance below threshold defined for stem cell transplantation according to local clinical standard * Respiratory failure necessitating supplemental oxygen * HIV infection * Concurrent severe or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which by assessment of the treating physician could compromise participation in the study * Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction) * Patients unwilling or unable to comply with the protocol or unable to give informed consent * Treatment with any investigational product within 4 weeks prior to study treatment (transfusion of the IMP)
References
Publications (0)
Data not yet available
No reference posted for this study.