VA Induction and Bridging Transplantation for Hypoplastic/Secondary AML
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Soochow University
About this trial
The purpose of this study is to explore the efficacy and safety of venetoclax combined with azacitidine（VA) induction followed by bridging allogeneic hematopoietic stem cell transplantation (allo-HSCT) in the treatment of hypoplastic and secondary acute myeloid leukemia (AML).
Eligibility criteria
Qualifiers
Age ≥18 years.
Previously untreated acute myeloid leukemia (AML) diagnosed according to the 2022 ELN guidelines. Patients with isolated extramedullary disease (i.e., no evidence of AML in bone marrow or peripheral blood) are not eligible.
Bone marrow biopsy demonstrating cellularity <20% or concurrent myelofibrosis; Or a prior history of an antecedent hematologic disorder, radiotherapy/chemotherapy-related history, or presence of myelodysplasia-related changes (AML-MRC according to WHO-HEAM5).
The patient is deemed suitable for allogeneic hematopoietic stem cell transplantation as assessed by the treating physician.
Disqualifiers
Prior treatment for AML, except non-cytotoxic therapy given to stabilize disease.
White blood cell count ≥10×10⁹/L, or presence of proliferation-associated gene mutations such as FLT3.
Favorable risk group according to the 2022 ELN prognostic stratification, e.g., t(8;21), inv(16)/t(16;16), NPM1 mutation, or CEBPA bZIP in-frame mutation.
No suitable stem cell donor available.
Trial design
Treatments tested in this trial
- Venetoclax (VEN)
- Azacitidine (AZA)
- Allo-HSCT
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
The First Affiliated Hospital of Soochow University
Lead sponsor
Nanfang Hospital, Southern Medical University
Collaborator
Ruijin Hospital North Shanghai Jiao Tong University School of Medicine
Collaborator
Source ClinicalTrials.gov