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VABu Conditioning in Elderly AML HSCT

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Enrolling by Invitation → Recruiting
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07583888
Lead Sponsor The First Affiliated Hospital of Soochow University
Collaborators: Suzhou Hongci Hematology Hospital, Suzhou, China, Huai'an Second People's Hospital and the Affiliated Huai'an Hospital of Xuzhou Medical University, Shenzhen People's Hospital, Henan Cancer Hospital
Conditions
(from sponsor)		 Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Acute Myeloid Leukemia (AML)
Related terms Leukemia, Myeloid, Acute
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov