Acute Myeloid LeukemiaPhase 1/2NCT05272293
Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young Adults With AML
A Phase 1/2 study testing NK cell infusions in people with Acute Myeloid Leukemia, run by Belarusian Research Center for Pediatric Oncology, Hematology and Immunology at 1 site in Belarus.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 30 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- NK cell infusions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Nov 2021to Jun 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients:
- primary high risk AML
- primary refractory AML
- relapsed AML
- Karnofsky or Lansky performance scale greater or equal to 70
- written informed consent
Show all 10Show fewer
- Donors:
- haploidentical family donor
- donor suitable for cell donation and apheresis according to standard criteria
- written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belarus1 site, 1 recruiting
- Recruiting
Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
Minsk, Minsk Oblast, 223053
Tatsiana Shman, +37529 6341853, shman@oncology.by
Mariya Naumovich, +375293563846, mariyanaumovich@gmail.com
About this study
Official title: Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young Adults With High-risk, Refractory or Relapsed AML
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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- NK cell infusions
- Keywords
- Natural killer cells, immunotherapy
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK cell infusionsBiological
Three doses of expanded haploidentical NK cells (30-100 x 10^6 cells /kg).
| Study group | Role | What they receive |
|---|---|---|
| expanded haploidentical NK cell immunotherapy | Experimental | After a cycle of chemotherapy a patient receive three intravenous infusions of expanded haploidentical NK cells. Receives: Biological: NK cell infusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after every a course of NK immunotherapy
Leukemia-free survival (LFS)
Time from achievement of CR/CRi/MLFS to the time of relapse, death in remission, or last follow-up.
Measured: 1 year
Overall survival (OS)
The proportion of patients with overall survival
Measured: 1 year
Secondary outcomes (2)
Duration of persistence of infused NK cells
Days of persistence of donor NK cells
Measured: 21 days after the first infusion
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.
Measured: 30 days after the first infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start1 Nov 2021
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olga Aleinikova, MD, Prof, Principal investigator, Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272293
- Sponsor's protocol ID
- haploNK_ HR/R/R_AML
- Status last verified
- Aug 2024
- First submitted
- 28 Feb 2022
- Last updated
- 28 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young Adults With High-risk, Refractory or Relapsed AML
- ClinicalTrials.gov ID
- NCT05272293
- Acronym / sponsor ID
- haploNK_ HR/R/R_AML
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Natural killer cells, immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Belarusian Research Center for Pediatric Oncology, Hematology and ImmunologyUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| expanded haploidentical NK cell immunotherapy | Experimental | Biological: NK cell infusionsAfter a cycle of chemotherapy a patient receive three intravenous infusions of expanded haploidentical NK cells. |
Who may qualify
- Ages
- 6 months to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- primary high risk AML
- primary refractory AML
- relapsed AML
- Karnofsky or Lansky performance scale greater or equal to 70
- written informed consent
Key exclusion criteria (7 listed)
- uncontrolled infection
- severe hepatic dysfunction: SGOT or SCPT >=5x upper limit of normal for age
- positive serology for human immunodeficiency virus (HIV)
- pregnancy
- positive serology for HIV, hepatitis B or C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NK cell infusionsThree doses of expanded haploidentical NK cells (30-100 x 10^6 cells /kg). | Biological | expanded haploidentical NK cell immunotherapy |
Primary outcome
Objective Response Rate (ORR) (PR+ MLFS+CRi +CR)
Time frame: 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)
Time frame: 1 year
Time from achievement of CR/CRi/MLFS to the time of relapse, death in remission, or last follow-up.
Overall survival (OS)
Time frame: 1 year
The proportion of patients with overall survival
2 secondary outcomes
Duration of persistence of infused NK cells
Time frame: 21 days after the first infusion
Number of T, B, NK, activated T and NK cells after immunotherapy
Time frame: 30 days after the first infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Aleinikova, MD, Prof principal investigator
Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NK cell infusions in people with Acute Myeloid Leukemia, run by Belarusian Research Center for Pediatric Oncology, Hematology and Immunology at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatsiana Shman, PhD (+375296341853, shman@oncology.by), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (PR+ MLFS+CRi +CR) (time frame: 30 days after every a course of NK immunotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.