VABu Conditioning in Elderly AML HSCT
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age60+
SponsorThe First Affiliated Hospital of Soochow University
About this trial
This is an open-label, multi-center, single-arm clinical study evaluating the efficacy and safety of the VABu conditioning regimen in elderly patients (≥60 years) with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
The VABu regimen consists of Venetoclax, Azacitidine, Semustine, Cytarabine, and Busulfan. All enrolled participants will receive the VABu regimen as conditioning therapy prior to HSCT.
The study aims to enroll 20 participants from multiple centers in China. The primary objectives are to evaluate the overall response rate, cumulative relapse rate, overall survival, graft-versus-host disease (GVHD)-free relapse-free survival (GRFS), non-relapse mortality (NRM), incidence of acute and chronic GVHD, and reactivation rates of cytomegalovirus (CMV) and Epstein-Barr virus (EBV). Safety outcomes include treatment-related toxicities, such as bone marrow suppression, infection, and organ dysfunction.
Eligibility criteria
Qualifiers
Age ≥ 60 years.
Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO classification, with intermediate or high-risk prognosis.
Previous response to Venetoclax-based therapy.
Planned to undergo allogeneic hematopoietic stem cell transplantation (HSCT).
Disqualifiers
Age < 60 years.
Poor response to prior Venetoclax-based therapy.
Unstable systemic disease (unstable angina, myocardial infarction, cerebrovascular accident within 3 months; NYHA Class III-IV heart failure; severe arrhythmia; pulmonary hypertension).
Active uncontrolled infection or active bleeding in vital organs.
Trial design
Treatments tested in this trial
- VaBU
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
The First Affiliated Hospital of Soochow University
Lead sponsor
Suzhou Hongci Hematology Hospital, Suzhou, China
Collaborator
Huai'an Second People's Hospital and the Affiliated Huai'an Hospital of Xuzhou Medical University
Collaborator
Shenzhen People's Hospital
Collaborator
Henan Cancer Hospital
Collaborator
Source ClinicalTrials.gov