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Lisaftoclax Plus Azacitidine Maintenance After Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients at High Risk of Relapse

30 juin 2026 mis à jour par: Institute of Hematology & Blood Diseases Hospital, China

Maintenance Therapy With Lisaftoclax Plus Azacitidine After Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients at High Risk of Relapse: A Multicenter, Open-Label, Randomized Controlled Trial

This study evaluates the efficacy and safety of maintenance therapy with lisaftoclax plus azacitidine after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adults with acute myeloid leukemia (AML) at high risk of relapse.

The main questions this study aims to answer are:

  • Does maintenance therapy with lisaftoclax plus azacitidine improve disease-free survival compared with observation alone after allo-HSCT?
  • Does maintenance therapy reduce relapse and improve overall survival?
  • What adverse events and safety outcomes are associated with this treatment strategy?

Researchers will compare maintenance therapy with lisaftoclax plus azacitidine with observation or best supportive care in patients with AML at high risk of relapse following allo-HSCT.

Participants will:

  • Be randomly assigned in a 2:1 ratio to receive either maintenance therapy with lisaftoclax plus azacitidine or observation.
  • Receive study treatment for up to 12 cycles or undergo observation according to the study assignment.
  • Undergo regular follow-up assessments, disease monitoring, and safety evaluations after transplantation.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

191

Phase

  • Phase 3

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

Participants must meet all of the following criteria to be eligible for enrollment in this study:

  1. Diagnosed with acute myeloid leukemia (AML), excluding acute promyelocytic leukemia, according to the WHO 2022 classification, and without FLT3-ITD or FLT3-TKD mutations.
  2. Presence of at least one of the following high-risk features:

1) Adverse-risk AML according to the ELN 2022 risk classification; 2) Refractory AML; 3) Relapsed AML; 4) Persistent measurable residual disease positivity prior to transplantation; 5) Secondary AML transformed from myelodysplastic syndrome or myeloproliferative neoplasm.

3. Undergoing first allogeneic hematopoietic stem cell transplantation (allo-HSCT).

4. Stable hematologic recovery, defined as: Absolute neutrophil count ≥ 1.0 × 10⁹/L without G-CSF support; and Platelet count ≥ 50 × 10⁹/L without platelet transfusion within 7 days prior to randomization.

5. Age ≥18 years and ≤75 years. 6. Eastern Cooperative Oncology Group performance status of 0-2. 7. Ability to provide written informed consent before initiation of any study procedures.

8. Written informed consent may be provided by the participant or an authorized immediate family member in accordance with local regulations.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded from the study:

  1. Evidence of disease relapse or impending relapse prior to randomization after transplantation, as determined by morphologic assessment or flow cytometry.
  2. Active or uncontrolled acute graft-versus-host disease (aGVHD) requiring systemic immunosuppressive therapy.
  3. Uncontrolled active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 7 days prior to enrollment.
  4. Moderate or severe hepatic impairment, as defined by the Child-Pugh classification.
  5. Severe renal impairment, defined as creatinine clearance <30 mL/min (calculated using the Cockcroft-Gault formula) or requirement for dialysis.
  6. Pregnancy, or unwillingness/inability to use adequate contraception during the study treatment period.
  7. Psychiatric disorders or other medical conditions that, in the investigator's judgment, would interfere with compliance with study treatment, monitoring, or study procedures.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Observation
Expérimental: Lisaftoclax plus Azacitidine Maintenance Therapy
Médicament: Lisaftoclax Plus Azacitidine
Participants will receive maintenance therapy with lisaftoclax plus azacitidine after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Lisaftoclax will be administered orally at a dose of 400 mg once daily on Days 1-7 of each treatment cycle. Azacitidine will be administered at a dose of 32 mg/m² by subcutaneous injection or intravenous infusion on Days 1-5 of each treatment cycle. Each treatment cycle is 28 days in length. Maintenance therapy will be administered for up to 12 cycles or until 15 months after allo-HSCT, whichever occurs first. The dose of lisaftoclax may be modified according to concomitant medications and treatment-related hematologic toxicities. The interval between treatment cycles may be extended based on individual tolerability and hematologic recovery.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Disease-Free Survival
Délai: 2 years
Disease status (including relapse) and survival outcomes will be evaluated for the assessment of disease-free survival (DFS). DFS is defined as the time from randomization to the first occurrence of relapse or death from any cause. Prespecified subgroup analyses will be conducted according to pre-transplant measurable residual disease (MRD) status (MRD-positive vs. MRD-negative) to assess the consistency of treatment effects across MRD subgroups.
2 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Cumulative Incidence of Relapse
Délai: 2 years
The cumulative incidence of relapse will be assessed during the follow-up period.
2 years
Overall Survival
Délai: 2 years.
Overall survival (OS) is defined as the time from randomization to death from any cause. Prespecified subgroup analyses will be conducted according to pre-transplant measurable residual disease (MRD) status to assess the consistency of treatment effects between MRD-positive and MRD-negative patients.
2 years.
Cumulative Incidence of Pre-emptive Therapy.
Délai: 2 years
Pre-emptive therapy rate is defined as the proportion of patients who receive additional anti-leukemic treatment triggered by measurable residual disease positivity or other molecular evidence of impending relapse after allogeneic hematopoietic stem cell transplantation.
2 years
Cumulative Incidence of Non-Relapse Mortality
Délai: 2-years.
Non-relapse mortality, defined as death without prior disease relapse or progression, assessed as a cumulative incidence.
2-years.
Treatment-Related Adverse Events
Délai: From initiation of maintenance therapy to 30 days after last dose of study drug.
Incidence, severity, and type of adverse events will be evaluated and graded according to CTCAE v5.0 during maintenance therapy and follow-up.
From initiation of maintenance therapy to 30 days after last dose of study drug.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Institute of Hematology & Blood Diseases Hospital, China

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

10 août 2026

Achèvement primaire (Estimé)

10 août 2030

Achèvement de l'étude (Estimé)

10 août 2030

Dates d'inscription aux études

Première soumission

30 juin 2026

Première soumission répondant aux critères de contrôle qualité

30 juin 2026

Première publication (Réel)

7 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IIT2026015

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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