Health Trials

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

ConditionAcute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-21
SponsorBelarusian Research Center for Pediatric Oncology, Hematology and Immunology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

uncontrolled infection;

severe hepatic dysfunction: SGOT or SCPT >=5x upper limit of normal for age;

positive serology for human immunodeficiency virus (HIV).

pregnancy;

Trial design

Design model

Single group

Treatments tested in this trial

  • Expanded haploidentical NK cells

    Biological/Vaccine

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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Expanded haploidentical NK cell immunotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Relapse-free survival (RFS)

Time from achievement of CR to the time of relapse or death from any cause.

Time frame
2 years
2

Overall survival (OS)

The proportion of patients with overall survival

Time frame
2 years

Secondary outcomes

1

Persistence of donor NK cells

Days of persistence of donor NK cells

Time frame
21 days after the first infusion
2

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.

Time frame
28 days after the first infusion

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Belarussian Research Center for Pediatric Oncology, Hematology and ImmunologyRecruiting223053, Minsk, Minsk OblastBelarusBelarus

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Lead sponsor

Source ClinicalTrials.gov
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