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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03669172
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : February 26, 2020
Information provided by (Responsible Party):
Martín, José Luis Díez, M.D.

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

Condition or disease Intervention/treatment Phase
ACUTE LEUKEMIA Biological: Donor IL-15 stimulated NK cells infusion Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 2, 2017
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: 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
Biological: Donor IL-15 stimulated NK cells infusion

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Reevaluation of the Minimal residual disease (MRD) [ Time Frame: Up to 1 year after first infusion ]
    Reevaluation of the Minimal residual disease (MRD) in bone marrow by flow cytometry

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03669172

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Contact: Yago Parga Cunqueiro +34695597268
Contact: Ana Pérez Corral

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Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact: Cristina Muñoz Martínez   
Contact: Nieves Dorado Herrero   
Principal Investigator: José Luís Diéz Martín         
Sponsors and Collaborators
Martín, José Luis Díez, M.D.
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Responsible Party: Martín, José Luis Díez, M.D. Identifier: NCT03669172    
Other Study ID Numbers: EC-HEM-HGUGM-2016-01
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Disease
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes