Comparing a stem cell transplant with venetoclax as follow-up treatment for older leukemia patients
Compares stem cell transplant with venetoclax treatment in older adults with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: RIC Allo-HSCT vs. Venetoclax-Based Consolidation in Elderly AML Patients After First CR
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 4
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 people aged 60 to 75 with acute myeloid leukemia (AML) who are in first complete remission after induction chemotherapy and have a stem cell donor. It compares a stem cell transplant with venetoclax-based treatment.
- Age
- 60 to 75 years
- Sex
- All sexes can join.
- Disease stage
- AML diagnosed by the 2022 WHO criteria. Intermediate- or high-risk AML by ELN criteria, AML with myelodysplasia-related changes, therapy-related AML, core-binding factor AML with D816 KIT mutation, or newly diagnosed hypercellular leukemia (WBC ≥ 10×10^9/L). Complete remission (CR) or CR with incomplete blood recovery (CRi) after one to two courses of induction chemotherapy.
- Earlier treatment
- One to two courses of induction chemotherapy that led to CR or CRi. A related, haploidentical or unrelated stem cell donor must be available.
- Biomarker or test result
- Core-binding factor AML needs the D816 KIT mutation. ELN risk group, MRC or therapy-related AML is also asked for.
Main reasons for not taking part
- Active heart disease, such as uncontrolled arrhythmia, uncontrolled high blood pressure, heart failure, NYHA class 3 or 4, or heart attack within 3 months
- Other severe disease that limits taking part, such as severe infection or kidney failure
- Known HIV infection or severe viral hepatitis not controlled by medication
- Pregnant or breastfeeding women
- Cannot understand or follow the study plan or sign the consent form
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 60 and 75 years old?
Source: NCT06571825, who can take part
Where in China
- The First Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaContact: Yanmin Zhao, PhDTaking people
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
- He Huang
- Trial code
- NCT06571825
- Record updated
- 26 August 2024
- Original description
Elderly patients with acute myeloid leukemia (AML) often face unfavorable prognostic factors such as multiple comorbidities, adverse cytogenetic profiles, and pre-existing hematological disorders. The long-term survival rate remains very low, with a 5-year survival rate of only 5% to 10%. The introduction of the BCL-2 inhibitor venetoclax (Ven) has improved the induction remission rates in elderly patients. However, the question of whether to use chemotherapy maintenance or proceed with allogeneic hematopoietic stem cell transplantation (allo-HSCT) for post-remission consolidation therapy remains unclear due to the lack of prospective controlled studies. Therefore, our center plans to conduct a prospective, open-label, two-arm, non-randomized, single-center study to further explore the optimal consolidation treatment strategy for elderly AML patients at intermediate and high risk following induction complete remission (CR).Read full original descriptionShow less
Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation in Comparison to Consolidation Therapy Based Venetoclax for Elderly Patients With Acute Myeloid Leukemia After First CR
Elderly patients with acute myeloid leukemia (AML) often face unfavorable prognostic factors such as multiple comorbidities, adverse cytogenetic profiles, and pre-existing hematological disorders. The long-term survival rate remains very low, with a 5-year survival rate of only 5% to 10%. The introduction of the BCL-2 inhibitor venetoclax (Ven) has improved the induction remission rates in elderly patients. However, the question of whether to use chemotherapy maintenance or proceed with allogeneic hematopoietic stem cell transplantation (allo-HSCT) for post-remission consolidation therapy remains unclear due to the lack of prospective controlled studies. Therefore, our center plans to conduct a prospective, open-label, two-arm, non-randomized, single-center study to further explore the optimal consolidation treatment strategy for elderly AML patients at intermediate and high risk following induction complete remission (CR).
Inclusion: Diagnosed with AML according to the 2022 WHO diagnostic criteria; Age 60-75 years; Intermediate to high-risk AML according to the ELN criteria, AML with myelodysplasia-related changes (AML-MRC) or therapy-related AML (t-AML), or core-binding factor AML (CBF-AML) with D816 KIT mutation; or newly diagnosed hypercellular leukemia (WBC ≥ 10×10\^9/L); Achieved CR or CR with incomplete hematologic recovery (CRi) after one to two courses of induction chemotherapy; Have a matched related, haploidentical, or mismatched unrelated hematopoietic stem cell donor; Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× the upper limit of normal (ULN), and total bilirubin ≤ 2× ULN; Echocardiography (ECHO) showing left ventricular ejection fraction (LVEF) ≥ 50%; Expected survival > 8 weeks; Voluntarily signed the informed consent form and can understand and comply with the study's requirements.
Exclusion: Currently has clinically active cardiovascular disease, such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any class 3 or 4 heart disease according to the New York Heart Association (NYHA) functional classification, or a history of myocardial infarction within 3 months before screening; Other severe diseases that may limit the patient's participation in this trial (e.g., severe infection, renal failure); Known human immunodeficiency virus (HIV) infection or severe viral hepatitis not controlled by medication; Pregnant or breastfeeding women; Unable to understand, comply with the study protocol, or unable to sign the informed consent form.