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NCT Number: NCT06783478

NK Cell Infusion for Remission Consolidation in AML: A Phase II Trial

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.

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Key information

Conditions

Acute Myeloid Leukaemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location contact

Lucia Silla Hematologist, MD, PhD

CONTACT

[email protected]

51 3359-8317 ext. 55

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

NK cell infusion

Biological

Six infusions of 1 x 10⁷/kg of haploidentical NK cells, in vitro expanded and activated.

Placebo

Other

Six infusions of placebo

Primary outcomes

  1. Event-free survival (EFS)

    Time frame: 24 months

Secondary outcomes

  1. Overall response rate (ORR)

    Time frame: 24 months

  2. 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).

  3. Immune Recovery

    Time frame: 24 months

  4. Chimerism

    Time frame: 24 months

  5. Depression Scale

    Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Lucia Silla Hematologist, MD, PhD

CONTACT

[email protected]

51 99911-2587 ext. 55

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Financiadora de Estudos e Projetos

Registry information

Official study title

Phase II Multicenter, Double-Blind, Prospective, Randomized Clinical Trial of NK Cell Infusion for Remission Consolidation in Patients With Acute Myeloid Leukemia

Acronym: NKLMA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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