Efectiveness of Donor IL-15-stimulated NK Cells Post Transplant Infusion in in Acute Leukemia

Martín, José Luis Díez, M.D.

Status and phase: Completed; Phase 2; Phase 1

Conditions: ACUTE LEUKEMIA

Treatments: Biological: Donor IL-15 stimulated NK cells infusion

Study type: Interventional

Identifiers

NCT03669172

EC-HEM-HGUGM-2016-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

NK cells infusion

Experimental group

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

Treatment:

Biological: Donor IL-15 stimulated NK cells infusion