Clinical trial · Interventional
Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma
Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma.
NCT01944982CI-TRIAL-00025221HNJ-NKAES-2012terminatedPhase 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
Why stopped (as posted): The low recruitment rate makes it very difficult to complete the study within a reasonable period of time.
Summary
Brief summary (as posted)
To determine safety profile of immunotherapy with natural killer cells and activated expanded (NKAEs) after salvage chemotherapy in relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma.
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 T Cell Lymphoblastic Leukaemia and Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Expanded haploidentical natural killer cells (NKAEs) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Activated natural killer cells
- description
- Activated natural killer cells
- interventionNames
- Biological: Expanded haploidentical natural killer cells (NKAEs)
Primary outcomes (1)
- measure
- Safety profile (number of AEs per patient)
- timeFrame
- Two months
Secondary outcomes (5)
- measure
- Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections
- timeFrame
- During 14 months
- measure
- time to hematological recovery (days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged between 0 and 21 years with relapsed or refractary acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. * Lansky Index \> 60%. * Left ventricular ejection fraction \> 39%. * Negative HIV serology. * Provide informed consent in accordance with current legislation. Exclusion Criteria: * Patients with a history of poor compliance. * Patients not valid after psycho-social evaluation * Severe (4) functional organ disorders (hepatic, renal, respiratory) according to NCI CTCAE v3 criteria
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