NCT07686965Not yet recruitingPhase 3
Lisaftoclax Plus Azacitidine Maintenance After Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients at High Risk of Relapse
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
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 191 (estimated)
- First submitted
- 30 Jun 2026
- Start date
- Aug 2026
- Primary completion date
- Aug 2030
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07686965
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 191
- From Aug 2026 to the primary completion date, Aug 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Evidence of disease relapse or impending relapse prior to randomization after transplantation, as determined by morphologic assessment or flow cytometry.
- Uncontrolled active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 7 days prior to enrollment.
Other illness
- Active or uncontrolled acute graft-versus-host disease (aGVHD) requiring systemic immunosuppressive therapy.
- Moderate or severe hepatic impairment, as defined by the Child-Pugh classification.
- Psychiatric disorders or other medical conditions that, in the investigator's judgment, would interfere with compliance with study treatment, monitoring, or study procedures.
Lab values
- Severe renal impairment, defined as creatinine clearance \<30 mL/min (calculated using the Cockcroft-Gault formula) or requirement for dialysis.
Other
- Participants meeting any of the following criteria will be excluded from the study:
- Pregnancy, or unwillingness/inability to use adequate contraception during the study treatment period.
Who the study is looking for
- Participants must meet all of the following criteria to be eligible for enrollment in this study:
- Diagnosed with acute myeloid leukemia (AML), excluding acute promyelocytic leukemia, according to the WHO 2022 classification, and without FLT3-ITD or FLT3-TKD mutations.
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.