Clinical trial · Interventional
"LANK-2": Activated and Expanded NK Cell Immunotherapy Together With Salvage Chemotherapy in Children, Adolescents and Young Adults With Relapsed or Refractary Acute Leukemia
NCT02074657CI-TRIAL-00025224LYDIAcompletedPhase 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)
To determine safety profile of immunotherapy with natural killer cells and activated expanded (NKAEs) after salvage chemotherapy in children, adolescents and young adults with relapsed or refractary acute leukemia
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 |
|---|---|---|---|
| Relapsed/Refractory Paediatric Acute Leukaemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Activated and expanded natural killer cells (NKAEs) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Activated natural killer cells
- interventionNames
- Biological: Activated and expanded natural killer cells (NKAEs)
Primary outcomes (1)
- measure
- To assess the safety of activated and expanded NK cell (NKAE) immunotherapy after salvage chemotherapy in patients with relapsed or refractary acute leukemia
- timeFrame
- 2 months after infusion
- description
- Number of patients with adverse events according to NCI-CTCAE v4.0 CRITERIA as a measure of safety and tolerability
Secondary outcomes (4)
- measure
- Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections
- timeFrame
- End of infusion and follow-up (2 months and 1 year)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 23 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients between 0 and 23 years of age with diagnosis of acute lymphoblastic leukemia, in second relapse situation, posttransplant relapse or refractary, or 2. Patients between 0 and 23 years of age with diagnosis of acute myeloblastic leukemia, relapsed or refractary. (Patient must meet inclusion criteria 1 or 2) 3. Lansky index \> 60% 4. Mild (\<2) functional organs alteration (hepatic, renal, respiratory) according to National Cancer Institute criteria (NCI CTCAE v4). 5. Left ventricular ejection fraction \> 39% 6. To grant informed consent in accordance with the current legal regulations. 7. Presence of a compatible haploidentical donor (father or mother or brother). Exclusion Criteria: 1. Patients with history of bad therapeutical compliance 2. Patients not valid after psycho-social evaluation 3. Positive HIV serology
References
Publications (1)
- DERIVEDVela M, Corral D, Carrasco P, Fernandez L, Valentin J, Gonzalez B, Escudero A, Balas A, de Paz R, Torres J, Leivas A, Martinez-Lopez J, Perez-Martinez A. Haploidentical IL-15/41BBL activated and expanded natural killer cell infusion therapy after salvage chemotherapy in children with relapsed and refractory leukemia. Cancer Lett. 2018 May 28;422:107-117. doi: 10.1016/j.canlet.2018.02.033. Epub 2018 Feb 23. PMID 29477379