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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05334693
• Other study ID #: HaploNK_consolidation_AML
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2021
• Est. completion date: June 2026

Study information

• Verified date: April 2022
• Source: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
• Contact: Tatsiana Shman, PhD
• Phone: +375296341853
• Email: shman[@]oncology.by
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia

Intervention

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

Locations

Country	Name	City	State
Belarus	Belarussian Research Center for Pediatric Oncology, Hematology and Immunology	Minsk	Minsk Region

Sponsors (1)

Lead Sponsor	Collaborator
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival (RFS)	Time from achievement of CR to the time of relapse or death from any cause.	2 years
Primary	Overall survival (OS)	The proportion of patients with overall survival	2 years
Secondary	Persistence of donor NK cells	Days of persistence of donor NK cells	21 days after the first infusion
Secondary	Number of T, B, NK, activated T and NK cells after immunotherapy	Analysis of T, B, NK, activated T and NK cells numbers (cells/microL) after NK infusions.	28 days after the first infusion