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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Study Overview
Brief Summary
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
Detailed Description
This clinical trial wants to study the safety, effectiveness and efficacy of NK cells incubated infusion (CD56 +, CD3) incubated ex vivo with IL-15 infusion in patients with high risk acute myeloid leukemia undergoing allogeneic transplant of an haploidentical donor with post-transplant cyclophosphamide administration.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •More than 18 years old, with acute myeloid leukemia who goes to undergo haploidentical
- •Assessable disease by analytic, molecular or image techniques.
- •Comorbidity Sorror index less than
- •Give informed consent according to the legal requirements.
- •Dispose of a donor without
Exclusion Criteria
- •Exclusion Criteria:
- •Positive HIV serology.
- •Patients with an active infection or other underlying serious medical statement.
- •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.
- •Participation of any other interventional clincal trial within 30 days of planned enrollment into this study.
- •Women who are pregnant or breastfeeding.
Arms & Interventions
NK cells infusion
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
Intervention: Donor IL-15 stimulated NK cells infusion (Biological)
Outcomes
Primary Outcomes
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame: Up to 2 years after first infusion
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Secondary Outcomes
- Reevaluation of the Minimal residual disease (MRD)(Up to 1 year after first infusion)