Health Trials

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

ConditionAcute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-30
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 for children/young adults with primary high risk or refractory AML and relapsed AML.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

primary high risk AML

primary refractory AML

relapsed AML

Karnofsky or Lansky performance scale greater or equal to 70

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

  • NK cell infusions

    Biological/Vaccine

    Three 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

Objective Response Rate (ORR) (PR+ MLFS+CRi +CR)

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.

Time frame
30 days after every a course of NK immunotherapy
2

Leukemia-free survival (LFS)

Time from achievement of CR/CRi/MLFS to the time of relapse, death in remission, or last follow-up.

Time frame
1 year
3

Overall survival (OS)

The proportion of patients with overall survival

Time frame
1 year

Secondary outcomes

1

Duration of persistence of infused 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
30 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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