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Completed

NCT Number: NCT03669172

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

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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Key information

Conditions

Acute Leukemia

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • More than 18 years old, with acute myeloid leukemia who goes to undergo haploidentical
  • Assessable disease by analytic, molecular or image techniques.
  • Comorbidity Sorror index less than 6.
  • Give informed consent according to the legal requirements.
  • Dispose of a donor without exclusion criteria.

Exclusion criteria

  • Positive HIV serology.
  • Patients with an active infection or other underlying serious medical statement.
  • 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.
  • Participation of any other interventional clincal trial within 30 days of planned enrollment into this study.
  • Women who are pregnant or breastfeeding.

Treatment and study plan

Donor IL-15 stimulated NK cells infusion

Biological

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Martín, José Luis Díez, M.D.

Indiv

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 13, 2018
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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