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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03669172

Enrollment

Registered

2018-09-13

Start date

2017-11-02

Completion date

2021-07-06

Last updated

2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACUTE LEUKEMIA

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.

Interventions

BIOLOGICALDonor IL-15 stimulated NK cells infusion

DONOR IL-15-STIMULATED NK CELLS POST TRANSPLANT INFUSION, IN ACUTE LEUKEMIA PATIENTS WITH POOR PROGNOSIS AND HAPLOIDENTICAL UNMANIPULATED TRANSPLANT

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0	Up to 2 years after first infusion	Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Secondary

Measure	Time frame	Description
Reevaluation of the Minimal residual disease (MRD)	Up to 1 year after first infusion	Reevaluation of the Minimal residual disease (MRD) in bone marrow by flow cytometry

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026