Clinical trial · Interventional
Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML
Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML
NCT05334693CI-TRIAL-00080249unknownPhase 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)
The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells as consolidation therapy for children/young adults with intermediate risk AML.
Conditions
Conditions (1)
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 Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Expanded haploidentical NK cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Expanded haploidentical NK cell immunotherapy
- description
- After a lymphodepleting chemotherapy a patient receive two intravenous infusions of expanded haploidentical NK cells.
- interventionNames
- Biological: Expanded haploidentical NK cells
Primary outcomes (2)
- measure
- Relapse-free survival (RFS)
- timeFrame
- 2 years
- description
- Time from achievement of CR to the time of relapse or death from any cause.
- measure
- Overall survival (OS)
- timeFrame
- 2 years
- description
- The proportion of patients with overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: Patients: * primary intermediate risk AML in molecular complete remission; * primary high risk AML in molecular complete remission awaiting unrelated HSCT; * Karnofsky or Lansky performance scale greater or equal to 70; * written informed consent. Donors: * haploidentical family donor; * donor suitable for cell donation and apheresis according to standard criteria; * written informed consent. Exclusion Criteria: Patients: * uncontrolled infection; * severe hepatic dysfunction: SGOT or SCPT \>=5x upper limit of normal for age; * positive serology for human immunodeficiency virus (HIV). Donors: * pregnancy; * positive serology for HIV, hepatitis B or C.
References
Publications (0)
Data not yet available
No reference posted for this study.