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

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ClinicalTrials.gov Identifier: NCT03669172
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
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
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 : September 20, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 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
DONOR IL-15-STIMULATED NK CELLS POST TRANSPLANT INFUSION, IN ACUTE LEUKEMIA PATIENTS WITH POOR PROGNOSIS AND HAPLOIDENTICAL UNMANIPULATED TRANSPLANT




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



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03669172


Contacts
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Contact: Yago Parga Cunqueiro +34695597268 yago.parga@ypsilon.es
Contact: Ana Pérez Corral apcorral@salud.madrid.org

Locations
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Spain
Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact: Cristina Muñoz Martínez       cmunozmartinez@salud.madrid.org   
Contact: Nieves Dorado Herrero       nieves.dorado@salud.madrid.org   
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.
ClinicalTrials.gov Identifier: NCT03669172     History of Changes
Other Study ID Numbers: EC-HEM-HGUGM-2016-01
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
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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Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes