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

Sponsor

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology (Other)

Overall Status

Recruiting

CT.gov ID

NCT05334693

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Biological: Expanded haploidentical NK cells	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Expanded haploidentical NK cell immunotherapy After a lymphodepleting chemotherapy a patient receive two intravenous infusions of expanded haploidentical NK cells.	Biological: Expanded haploidentical NK cells Two doses of expanded haploidentical NK cells (30-100 x 10^6 cells /kg).

Arm

Intervention/Treatment

Experimental: Expanded haploidentical NK cell immunotherapy

After a lymphodepleting chemotherapy a patient receive two intravenous infusions of expanded haploidentical NK cells.

Biological: Expanded haploidentical NK cells

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

Outcome Measures

Primary Outcome Measures

Relapse-free survival (RFS) [2 years]
Time from achievement of CR to the time of relapse or death from any cause.
Overall survival (OS) [2 years]
The proportion of patients with overall survival

Secondary Outcome Measures

Persistence of donor NK cells [21 days after the first infusion]
Days of persistence of donor NK cells
Number of T, B, NK, activated T and NK cells after immunotherapy [28 days after the first infusion]
Analysis of T, B, NK, activated T and NK cells numbers (cells/microL) after NK infusions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Belarussian Research Center for Pediatric Oncology, Hematology and Immunology	Minsk	Minsk Region	Belarus	223053

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

ClinicalTrials.gov Identifier:

NCT05334693

Other Study ID Numbers:

HaploNK_consolidation_AML

First Posted:

Apr 19, 2022

Last Update Posted:

Apr 19, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Natural killer cells

Immunotherapy

Study Results

No Results Posted as of Apr 19, 2022