Clinical trial · Interventional
Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk AML
Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With Haploidentical Natural Killer Cells in High-risk Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low recruitment rate
Summary
Brief summary (as posted)
The trial investigates the efficacy of adoptive immunotherapy with haploidentical natural killer cells compared to standard chemotherapy (after first complete remission) in patients with a high-risk acute myeloid leukemia being older than 65 years of age and not eligible for allogeneic transplantation
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| NK cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NK cells
- description
- Infusion of haploidentical NK cells after immunosuppression with cyclophosphamide and fludarabine, followed by immunostimulatory treatment with interleukin-2
- interventionNames
- Biological: NK cells
- type
- ACTIVE_COMPARATOR
- label
- Control Intervention
- description
- 1 cycle of consolidation chemotherapy with high-dose cytarabine
- interventionNames
- Drug: Cytarabine
Primary outcomes (1)
- measure
- 2-year overall survival
- timeFrame
- 2 years after study inclusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria * In AML defined by cytogenetic aberrations the proportion of blasts may be \<20% * Age ≥60 years * Clinical performance corresponding to ECOG score 0-2 * High-risk karyotype * \<5% myeloblasts in bone marrow ≥21 days after beginning of most recent chemotherapy * maximal two preceding chemotherapy cycles * Potentially available haploidentical family donor (child/ sibling), willing and fit for NK cell donation Exclusion Criteria: * AML with favorable or intermediate risk cytogenetic features * Persistent aplasia following preceding chemotherapy * Relapsed or refractory AML * Known pre-existing autoimmune diseases * Any severe concomitant condition which makes it undesirable for the patient to participate in the study * Any condition which could jeorpadize compliance of the protocol * Participation in another clinical trial during or within 4 weeks before study entry
References
Publications (0)
Data not yet available