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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
VaBU
DrugThe VABu conditioning regimen is administered prior to allogeneic hematopoietic stem cell transplantation (HSCT). The regimen consists of the following drugs administered sequentially: Venetoclax: 600 mg/m² orally once daily on days -10 to -5. Azacitidine: 75 mg/m² subcutaneously once daily on days -10 to -6. Semustine: 250 mg/m² orally once on day -10. Cytarabine: 2 g/m² intravenously once daily on day -1. Busulfan: 0.8 mg/kg intravenously every 6 hours on days -4 to -2 (total of 12 doses). The conditioning regimen is completed before HSCT. Dose adjustments may be made based on toxicity, concomitant medications (especially CYP3A4 inhibitors), and individual patient tolerance.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: VaBUExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the date of transplantation to the date of disease progression, relapse, or death from any cause, whichever occurs first. Participants who are alive without progression or relapse at the last follow-up are censored.
Time frame
1 year and 2 years post-transplantationSecondary outcomes
1
Overall Survival (OS)
Overall survival is defined as the time from the date of transplantation to the date of death from any cause. Participants who are alive at the last follow-up are censored.
Time frame
1 year and 2 years post-transplantation2
Cumulative Incidence of Relapse (CIR)
Time frame
1 year, 2 years3
Non-relapse Mortality (NRM)
Time frame
Day 100, 1 year, 2 years4
GVHD-free Relapse-free Survival (GRFS)
Time frame
1 year, 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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