Venetoclax and azacitidine before stem cell transplant for hard-to-treat leukemia
Tests venetoclax with azacitidine, then transplant, in adults with leukemia.
Plain-language title generated from the registry record
Registry title: VA Induction and Bridging Transplantation for Hypoplastic/Secondary AML
Key facts
- Where
- Suzhou, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed acute myeloid leukemia (AML) that is hypoplastic or comes after another blood disease or earlier cancer treatment. Treatment is venetoclax with azacitidine, then a stem cell transplant from a donor.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Acute myeloid leukemia not treated before. Either bone marrow with cellularity under 20% or myelofibrosis, or an earlier blood disorder, earlier chemotherapy or radiotherapy, or myelodysplasia-related changes.
- Earlier treatment
- No earlier treatment for AML, except non-cytotoxic therapy given to keep the disease stable. No earlier donor stem cell transplant for a blood disease.
- Biomarker or test result
- Cannot have FLT3 or similar proliferation-related gene changes. Cannot have the favorable-risk changes t(8;21), inv(16)/t(16;16), NPM1 mutation or CEBPA bZIP in-frame mutation.
Main reasons for not taking part
- White blood cell count of 10×10⁹/L or higher
- Acute promyelocytic leukemia or leukemia in the central nervous system
- No stem cell donor available
- Active uncontrolled infection, or HIV, hepatitis B or hepatitis C that therapy cannot control
- Pregnant or breastfeeding
Read by machine on 9 November 2026.
Where in China
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT07635485
- Record updated
- 9 June 2026
- Original description
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).Read full original descriptionShow less
A Multicenter, Single-arm Clinical Study of Venetoclax Combined With Azacitidine Induction and Bridging to Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Hypoplastic or Secondary Acute Myeloid Leukemia
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).
Inclusion: 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; Adequate organ function, defined as follows: a. Good liver function: serum total bilirubin ≤2.0 × upper limit of normal (ULN); if considered due to Gilbert's disease or leukemia, serum total bilirubin <3.0 × ULN. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤3.0 × ULN, unless considered due to leukemia. b. Good renal function: serum creatinine ≤2.0 × ULN or creatinine clearance >30 mL/min calculated using the Cockcroft-Gault formula. c. No history of chronic lung disease and no dyspnea. Otherwise, documented diffusing capacity of the lung for carbon monoxide ≤40% (adjusted for hemoglobin if available) and forced expiratory volume in 1 second/forced vital capacity ≥50%; ECOG performance status score 0-2; Ability to understand and voluntarily sign informed consent; Women of childbearing potential must have a negative serum pregnancy test before initiation of study treatment.
Exclusion: Prior treatment for AML, except non-cytotoxic therapy given to stabilize disease; Prior allogeneic hematopoietic stem cell transplantation for a hematologic disorder; Current use of strong CYP3A4 inducers or narrow-therapeutic-window CYP3A4 substrates; enrollment is allowed only if these drugs can be switched to alternatives ≥5 half-lives before the first dose of study treatment; Another active malignancy, unless the patient has been disease-free for ≥5 years before initiation of study treatment. However, patients with the following history/concurrent conditions or similar indolent cancers are eligible: Basal cell or squamous cell carcinoma of the skin Carcinoma in situ of the cervix Carcinoma in situ of the breast Prostate cancer found incidentally on histology; Significant active cardiac disease within 6 months before initiation of study treatment, including New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction, unstable angina, and/or stroke; Life-threatening immediate complications of leukemia, such as uncontrolled bleeding, hypoxic pneumonia, sepsis, and/or disseminated intravascular coagulation (DIC). Expected survival <12 weeks; Active, uncontrolled systemic fungal, bacterial, or viral infection despite appropriate antibiotic, antiviral, or other therapy; Known infection with human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) or hepatitis C virus (HCV) that cannot be controlled by therapy; Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg); Dysphagia, short-bowel syndrome, gastroparesis, or other conditions that limit oral intake or gastrointestinal absorption; Known history of progressive multifocal leukoencephalopathy (PML); Known hypersensitivity to any component of venetoclax or azacitidine; Any other medical or psychological condition that, in the investigator's opinion, could interfere with the patient's ability to sign informed consent or participate in the study; 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; Acute promyelocytic leukemia (APL); Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia; Female patient who is pregnant or breastfeeding.