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NCT Number: NCT05334693

Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML

The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells as consolidation therapy for children/young adults with intermediate risk AML.

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Key information

Age range

6 month–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Belarussian Research Center for Pediatric Oncology, Hematology and Immunology

Minsk, Minsk Oblast, 223053, Belarus

Location status: Recruiting

Location contact

Olga Aleinikova

PRINCIPAL_INVESTIGATOR

Tatsiana Shman

CONTACT

[email protected]

+37529 6341853

About this study

Immunotherapy with NK cells may improve the treatment results in AML. For better efficiency high cell doses or several infusions of NK cells are required. For this purpose, donor NK cells are expanded in the presence of feeder K562-mbIL21-41BBL cell line. The cycle of immunotherapy includes chemotherapy (cyclophosphamide, fludarabine) followed by two doses of NK cells infusion.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients:

  • primary intermediate risk AML in molecular complete remission;
  • primary high risk AML in molecular complete remission awaiting unrelated HSCT;
  • Karnofsky or Lansky performance scale greater or equal to 70;
  • written informed consent.

Donors:

  • haploidentical family donor;
  • donor suitable for cell donation and apheresis according to standard criteria;
  • written informed consent.

Exclusion criteria

Patients:

  • uncontrolled infection;
  • severe hepatic dysfunction: SGOT or SCPT >=5x upper limit of normal for age;
  • positive serology for human immunodeficiency virus (HIV).

Donors:

  • pregnancy;
  • positive serology for HIV, hepatitis B or C.

Treatment and study plan

Expanded haploidentical NK cells

Biological

Two doses of expanded haploidentical NK cells (30-100 x 10^6 cells /kg).

Primary outcomes

  1. Relapse-free survival (RFS)

    Time frame: 2 years

    Time from achievement of CR to the time of relapse or death from any cause.

  2. Overall survival (OS)

    Time frame: 2 years

    The proportion of patients with overall survival

Secondary outcomes

  1. Persistence of donor NK cells

    Time frame: 21 days after the first infusion

    Days of persistence of donor NK cells

  2. Number of T, B, NK, activated T and NK cells after immunotherapy

    Time frame: 28 days after the first infusion

    Analysis of T, B, NK, activated T and NK cells numbers (cells/microL) after NK infusions.

Study contacts

Contact information is provided by the study sponsor or research team.

Mariya Naumovich, MD

CONTACT

[email protected]

+375293563846

Tatsiana Shman, PhD

CONTACT

[email protected]

+375296341853

Sponsors and collaborators

Lead sponsor

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Other

Registry information

Official study title

Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Apr 19, 2022
Registry last updated
Aug 28, 2024

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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