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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-02

Study Completion Date

2021-07-06

Brief Summary

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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

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Detailed Description

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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.

Conditions

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ACUTE LEUKEMIA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Donor IL-15 stimulated NK cells infusion

Intervention Type BIOLOGICAL

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

Interventions

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Donor 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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No