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Recruiting NCT05334693

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

Phase I / Phase II Interventional Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Expanded haploidentical NK cells.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia. Basic parameters: 6 months — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belarus
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Relapse-free survival (RFS) [Time frame: 2 years]
  • Overall survival (OS) [Time frame: 2 years]
Secondary outcome measures (2)
  • Persistence of donor NK cells [Time frame: 21 days after the first infusion]
  • Number of T, B, NK, activated T and NK cells after immunotherapy [Time frame: 28 days after the first infusion]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Belarus · 1 center
  • Belarussian Research Center for Pediatric Oncology, Hematology and Immunology — Minsk

Identifiers

NCT: NCT05334693 · HaploNK_consolidation_AML

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗