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Recruiting NCT05272293

Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells 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: NK cell infusions.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia. Basic parameters: 6 months — 30 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 for Children/Young Adults With High-risk, Refractory or Relapsed AML

Overview

The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells for children/young adults with primary high risk or refractory AML and relapsed 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.

For patients with high-risk primary AML a cycle of immunotherapy includes chemotherapy (HD-ARA-C+IDA) followed by three doses of NK cells infusion.

For patients with refractory/relapsed AML a cycle of immunotherapy includes chemotherapy (FLAG - fludarabine, cytarabine, G-CSF) followed by three doses of NK cells infusion.

A 2nd cycle of therapy may be administered if a recipient continues to meet the eligibility criteria.

Interventions

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

Primary outcome measures

  • Objective Response Rate (ORR) (PR+ MLFS+CRi +CR) [Time frame: 30 days after every a course of NK immunotherapy]
  • Leukemia-free survival (LFS) [Time frame: 1 year]
  • Overall survival (OS) [Time frame: 1 year]
Secondary outcome measures (2)
  • Duration of persistence of infused NK cells [Time frame: 21 days after the first infusion]
  • Number of T, B, NK, activated T and NK cells after immunotherapy [Time frame: 30 days after the first infusion]

Eligibility criteria

Inclusion criteria

Patients:

  • primary high risk AML
  • primary refractory AML
  • relapsed AML
  • 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: NCT05272293 · haploNK_ HR/R/R_AML

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗