Acute Myeloid Leukaemia (AML)Phase 2NKLMANCT06783478
NK Cell Infusion for Remission Consolidation in AML: A Phase II Trial
A Phase 2 study testing NK cell infusion in people with Acute Myeloid Leukaemia (AML), run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Acute Myeloid Leukemia (AML) is a complex and rapidly progressive disease with high mortality. Although significant progress has been made in recent years with the development of new drugs, resulting in better therapeutic tolerability and increased survival, disease relapse occurs in most cases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukaemia (AML)
- What is being tested?
- NK cell infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 to 59 years, and 60 to 75 years if their score is < 0.4 on the 10-minute Comprehensive Geriatric Assessment (CGA-10);
- Recently diagnosed acute myeloid leukemia, excluding acute promyelocytic leukemia confirmed by the molecular finding of PML-RARA or the presence of t(15:17) in genetic evaluation;
- In first complete hematologic remission after remission induction;
- Eligible, in the opinion of the principal investigator, to undergo consolidation chemotherapy with HDAra-C;
- No history of NYHA > III heart failure, acute myocardial infarction, or unstable angina in the past 6 months;
- Negative beta-HCG test for women of childbearing potential and agreement to use contraceptive methods throughout the treatment, from the time of informed consent signature until one month after the last dose of treatment;
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- Non-reactive HIV serology;
- No prior investigational therapy in the 4 weeks before study enrollment;
- Availability of a haploidentical peripheral blood donor;
- Signed informed consent form.
Who cannot join
- Patients under 18 years of age; or aged 60 to 75 years with a score > 0.4 on the CGA-10 scale; or over 76 years of age, regardless of the score on the CGA-10 scale.
- Diagnosis of acute promyelocytic leukemia confirmed by the molecular finding of PML-RARA or the presence of t(15:17) in genetic evaluation.
- Failure to achieve first complete hematologic remission after remission induction.
- Ineligible, in the investigator's opinion, to undergo consolidation chemotherapy with HDAra-C.
- History of NYHA > III heart failure, acute myocardial infarction, or unstable angina in the past 6 months.
- Positive beta-HCG test for women of childbearing potential or non-compliance with using contraceptive methods throughout the treatment, from the time of informed consent signature until one month after the last dose of treatment.
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- Reactive HIV serology.
- Prior investigational therapy in the four weeks preceding study enrollment.
- Lack of availability of a haploidentical peripheral blood donor.
- Failure to sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903
Lucia Silla Hematologist, MD, PhD, 51 3359-8317 ext. 55, lsilla@hcpa.edu.br
About this study
Official title: Phase II Multicenter, Double-Blind, Prospective, Randomized Clinical Trial of NK Cell Infusion for Remission Consolidation in Patients With Acute Myeloid Leukemia
Acute Myeloid Leukemia (AML) is a complex and rapidly progressive disease with high mortality. Although significant progress has been made in recent years with the development of new drugs, resulting in better therapeutic tolerability and increased survival, disease relapse occurs in most cases. Adoptive immunotherapy has been increasingly emerging as an innovative alternative for cancer treatment. Among the immune cells tested, natural killer (NK) cells appear to exert significant antileukemic activity, particularly against AML, as demonstrated by numerous phase I/II studies published in the literature, including studies from our group.
This study aims to test whether haploidentical NK cells from healthy individuals, expanded and activated in vitro, administered when the disease is nearly eradicated by chemotherapy, can eliminate residual disease, delaying or eliminating the possibility of relapse. It is a randomized, superiority, double-blind, placebo-controlled clinical trial conducted at two treatment centers in Brazil. Adult patients aged 18 to 75 years with AML, from any risk group, in complete remission after completing standard treatment, will be included. Those with a bone marrow donor and eligible for this treatment will be allowed to undergo hematopoietic stem cell transplantation (HSCT). The study's objective is to determine whether the infusion of haploidentical NK cells immediately after high-dose chemotherapy results in increased event-free survival (EFS), overall survival (OS), and lower minimal residual disease (MRD) during follow-up or immediately before HSCT compared to patients undergoing the same treatment without NK cell infusion. A total of 98 participants in complete remission (CR) will be randomized to receive 6 infusions of 1 x 10⁷ NK cells/kg or 6 placebo infusions.
All participants will be evaluated for immune recovery at the cellular and molecular levels, and their immune profiles will be compared to analyze cellular response mechanisms.
- Conditions
- Acute Myeloid Leukaemia (AML)
- Being tested
- NK cell infusion, Placebo
- Keywords
- Adoptive Immunotherapy, Natural Killer Cells, Acute Myeloid Leukemia
- 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 infusionBiological
Six infusions of 1 x 10⁷/kg of haploidentical NK cells, in vitro expanded and activated.
PlaceboOther
Six infusions of placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Six infusions of 1 x 10⁷/kg of haploidentical NK cells, in vitro expanded and activated. Receives: Biological: NK cell infusion |
| Placebo | Placebo comparator | Six infusions of placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
Measured: 24 months
Secondary outcomes (5)
Overall response rate (ORR)
Measured: 24 months
Pre-transplant minimal residual disease (MRD) measurement
Measured: The minimal residual disease (MRD) will be measured 4 weeks before the transplant for patients who will undergo hematopoietic stem cell transplantation (HSCT).
Immune Recovery
Measured: 24 months
Chimerism
Measured: 24 months
Depression Scale
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukaemia (AML)Studies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783478
- Sponsor's protocol ID
- 2024-0533
- Other IDs
- D9A9CC97-F464-4C99-AC57-1E0E93
- Acronym
- NKLMA
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter, Double-Blind, Prospective, Randomized Clinical Trial of NK Cell Infusion for Remission Consolidation in Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06783478
- Acronym / sponsor ID
- NKLMA / 2024-0533
- Conditions
- Acute Myeloid Leukaemia (AML)
- Keywords
- Adoptive Immunotherapy, Natural Killer Cells, Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jan 2025 (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.
Acute Myeloid Leukemia (AML) is a complex and rapidly progressive disease with high mortality. Although significant progress has been made in recent years with the development of new drugs, resulting in better therapeutic tolerability and increased survival, disease relapse occurs in most cases. Adoptive immunotherapy has been increasingly emerging as an innovative alternative for cancer treatment. Among the immune cells tested, natural killer (NK) cells appear to exert significant antileukemic activity, particularly against AML, as demonstrated by numerous phase I/II studies published in the literature, including studies from our group.
This study aims to test whether haploidentical NK cells from healthy individuals, expanded and activated in vitro, administered when the disease is nearly eradicated by chemotherapy, can eliminate residual disease, delaying or eliminating the possibility of relapse. It is a randomized, superiority, double-blind, placebo-controlled clinical trial conducted at two treatment centers in Brazil. Adult patients aged 18 to 75 years with AML, from any risk group, in complete remission after completing standard treatment, will be included. Those with a bone marrow donor and eligible for this treatment will be allowed to undergo hematopoietic stem cell transplantation (HSCT). The study's objective is to determine whether the infusion of haploidentical NK cells immediately after high-dose chemotherapy results in increased event-free survival (EFS), overall survival (OS), and lower minimal residual disease (MRD) during follow-up or immediately before HSCT compared to patients undergoing the same treatment without NK cell infusion. A total of 98 participants in complete remission (CR) will be randomized to receive 6 infusions of 1 x 10⁷ NK cells/kg or 6 placebo infusions.
All participants will be evaluated for immune recovery at the cellular and molecular levels, and their immune profiles will be compared to analyze cellular response mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: NK cell infusionSix infusions of 1 x 10⁷/kg of haploidentical NK cells, in vitro expanded and activated. |
| Placebo | Placebo comparator | Other: PlaceboSix infusions of placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients aged 18 to 59 years, and 60 to 75 years if their score is < 0.4 on the 10-minute Comprehensive Geriatric Assessment (CGA-10);
- Recently diagnosed acute myeloid leukemia, excluding acute promyelocytic leukemia confirmed by the molecular finding of PML-RARA or the presence of t(15:17) in genetic evaluation;
- In first complete hematologic remission after remission induction;
- Eligible, in the opinion of the principal investigator, to undergo consolidation chemotherapy with HDAra-C;
- No history of NYHA > III heart failure, acute myocardial infarction, or unstable angina in the past 6 months;
Key exclusion criteria (10 listed)
- Patients under 18 years of age; or aged 60 to 75 years with a score > 0.4 on the CGA-10 scale; or over 76 years of age, regardless of the score on the CGA-10 scale.
- Diagnosis of acute promyelocytic leukemia confirmed by the molecular finding of PML-RARA or the presence of t(15:17) in genetic evaluation.
- Failure to achieve first complete hematologic remission after remission induction.
- Ineligible, in the investigator's opinion, to undergo consolidation chemotherapy with HDAra-C.
- History of NYHA > III heart failure, acute myocardial infarction, or unstable angina in the past 6 months.
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 infusionSix infusions of 1 x 10⁷/kg of haploidentical NK cells, in vitro expanded and activated. | Biological | Treatment |
| PlaceboSix infusions of placebo | Other | Placebo |
Primary outcome
Event-free survival (EFS)
Time frame: 24 months
5 secondary outcomes
Overall response rate (ORR)
Time frame: 24 months
Pre-transplant minimal residual disease (MRD) measurement
Time frame: The minimal residual disease (MRD) will be measured 4 weeks before the transplant for patients who will undergo hematopoietic stem cell transplantation (HSCT).
Immune Recovery
Time frame: 24 months
Chimerism
Time frame: 24 months
Depression Scale
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NK cell infusion in people with Acute Myeloid Leukaemia (AML), run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 10 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: opening soon, as of the sponsor's last update on 20 Jan 2025. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucia Silla Hematologist, MD, PhD (51 99911-2587 ext. 55, lsilla@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: 24 months). 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 20 Jan 2025.