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

August 27, 2024 updated by: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young Adults With High-risk, Refractory or Relapsed AML

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belarus
    • Minsk Region
      • Minsk, Minsk Region, Belarus, 223053
        • Recruiting
        • Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Olga Aleinikova, MD, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: expanded haploidentical NK cell immunotherapy
After a cycle of chemotherapy a patient receive three intravenous infusions of expanded haploidentical NK cells.
Biological: NK cell infusions
Three doses of expanded haploidentical NK cells (30-100 x 10^6 cells /kg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) (PR+ MLFS+CRi +CR)
Time Frame: 30 days after every a course of NK immunotherapy
The proportion of patients with complete remission (CR), CR with incomplete hematologic recovery (CRi), morphologic leukemia-free state (MLFS), and partial remission (PR) as measured by response criteria definitions for acute myeloid leukemia.
30 days after every a course of NK immunotherapy
Leukemia-free survival (LFS)
Time Frame: 1 year
Time from achievement of CR/CRi/MLFS to the time of relapse, death in remission, or last follow-up.
1 year
Overall survival (OS)
Time Frame: 1 year
The proportion of patients with overall survival
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of T, B, NK, activated T and NK cells after immunotherapy
Time Frame: 30 days after the first infusion
Analysis of T, B, NK, activated T and NK cells numbers (cells/microL) after NK infusions.
30 days after the first infusion
Duration of persistence of infused NK cells
Time Frame: 21 days after the first infusion
Days of persistence of donor NK cells
21 days after the first infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Investigators

  • Principal Investigator: Olga Aleinikova, MD, Prof, Belarussian Research Center for Pediatric Oncology, Hematology and Immunology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria

February 28, 2022

First Posted (Actual)

March 9, 2022

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • haploNK_ HR/R/R_AML

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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