Acute Myeloid Leukemia
Conditions
Keywords
Natural killer cells, immunotherapy
Brief summary
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.
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. For patients with high-risk primary AML a cycle of immunotherapy includes chemotherapy (HD-ARA-C+IDA) followed by three doses of NK cells infusion. For patients with refractory/relapsed AML a cycle of immunotherapy includes chemotherapy (FLAG - fludarabine, cytarabine, G-CSF) followed by three doses of NK cells infusion. A 2nd cycle of therapy may be administered if a recipient continues to meet the eligibility criteria.
Interventions
BIOLOGICALNK cell infusions
Three doses of expanded haploidentical NK cells (30-100 x 10\^6 cells /kg).
Sponsors
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 30 Years
Healthy volunteers
No
Inclusion criteria
Patients: * primary high risk AML * primary refractory AML * relapsed AML * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) (PR+ MLFS+CRi +CR) | 30 days after every a course of NK immunotherapy | 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. |
| Leukemia-free survival (LFS) | 1 year | Time from achievement of CR/CRi/MLFS to the time of relapse, death in remission, or last follow-up. |
| Overall survival (OS) | 1 year | The proportion of patients with overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of persistence of infused 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 | 30 days after the first infusion | Analysis of T, B, NK, activated T and NK cells numbers (cells/microL) after NK infusions. |
Countries
Belarus
Contacts
Primary ContactTatsiana Shman, PhD
Backup ContactMariya Naumovich, MD
Outcome results
None listed