Clinical trial · Interventional
Efectiveness of Donor IL-15-stimulated NK Cells Post Transplant Infusion in in Acute Leukemia
Fase I/II, Unicentric, Historical Control Clinical Trial to Evaluate the Effectiveness of Donor IL-15 Stimulated NK Cells Post Transplant Infusion, in Acute Leukemia Patients With Poor Prognosis and Haploidentical Unmanipulated Transplant
NCT03669172CI-TRIAL-00053683completedPhase 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)
Clinical trial phase I and II, single-center, historical control, to evaluate the effectiveness of donor IL-15 stimulated NK cells post transplant infusion, in acute leukemia patients with poor prognosis and haploidentical unmanipulated transplant
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 LEUKEMIA | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donor IL-15 stimulated NK cells infusion | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NK cells infusion
- description
- NK cells incubated infusion (CD56 +, CD3) ex vivo with IL-15 in patients with acute myeloid leukemia undergoing high-risk allogeneic haploidentical Pt-C donor
- interventionNames
- Biological: Donor IL-15 stimulated NK cells infusion
Primary outcomes (1)
- measure
- Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
- timeFrame
- Up to 2 years after first infusion
- description
- Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Secondary outcomes (1)
- measure
- Reevaluation of the Minimal residual disease (MRD)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. More than 18 years old, with acute myeloid leukemia who goes to undergo haploidentical 2. Assessable disease by analytic, molecular or image techniques. 3. Comorbidity Sorror index less than 6. 4. Give informed consent according to the legal requirements. 5. Dispose of a donor without exclusion criteria. Exclusion Criteria: 1. Positive HIV serology. 2. Patients with an active infection or other underlying serious medical statement. 3. Any medical process, analytical abnormality or important psychiatric disorder, according to the investigator's opinion, that prevent the participation of the patient in the study. 4. Participation of any other interventional clincal trial within 30 days of planned enrollment into this study. 5. Women who are pregnant or breastfeeding.
References
Publications (0)
Data not yet available
No reference posted for this study.