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

NCT ID: NCT05334693

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2026-06-30

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.

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Expanded haploidentical NK cell immunotherapy

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

Group Type: EXPERIMENTAL

Expanded haploidentical NK cells

Intervention Type: BIOLOGICAL

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

Interventions

Expanded haploidentical NK cells

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olga Aleinikova, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Belarussian Research Center for Pediatric Oncology, Hematology and Immunology

Locations

Belarussian Research Center for Pediatric Oncology, Hematology and Immunology

Minsk, Minsk Oblast, Belarus

Site Status: RECRUITING

Countries

Belarus

Central Contacts

Tatsiana Shman, PhD

Role: CONTACT

shman@oncology.by

+375296341853

Mariya Naumovich, MD

Role: CONTACT

mariyanaumovich@gmail.com

+375293563846

Facility Contacts

Tatsiana Shman

Role: primary

shman@oncology.by

+37529 6341853

Other Identifiers

HaploNK_consolidation_AML

Identifier Type: -

Identifier Source: org_study_id