Tests venetoclax as maintenance treatment in older adults with acute myeloid leukemia
Tests venetoclax tablets to help keep older adults with leukemia in remission.
Plain-language title generated from the registry record
Registry title: Clinical Study Protocol of Maintenance Therapy With Venetoclax in Elderly Patients With AML in First Complete Remission
Key facts
- Where
- Nanjing, 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 older adults with acute myeloid leukemia (AML) who are in first complete remission after treatment and have finished consolidation treatment. It tests maintenance therapy with venetoclax (Venclexta).
- Age
- 60 to 85 years
- Sex
- All sexes can join.
- Disease stage
- AML confirmed by bone marrow tests, in first complete remission (CR or CRi) after 1-2 cycles of induction therapy. Performance status (ECOG) 0-3.
- Earlier treatment
- Must have had 1-2 cycles of induction therapy and at least 4 cycles of consolidation treatment. People who had an allogeneic stem cell transplant cannot join.
Main reasons for not taking part
- Acute promyelocytic leukemia, myeloid sarcoma, or blast phase of chronic myeloid leukemia
- Remission reached only after a relapse and re-induction therapy
- AML outside the bone marrow, including active leukemia in the central nervous system
- Serious heart disease, or liver or kidney tests beyond the limits set in the record
- HIV/AIDS, syphilis, active hepatitis B, or hepatitis C
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 85 years old?
Source: NCT05909293, who can take part
Where in China
- The First Affiliated Hospital with Nanjing Medical UniversityNanjing, ChinaContact: Ming HongTaking 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
- The First Affiliated Hospital with Nanjing Medical University
- Trial code
- NCT05909293
- Record updated
- 18 June 2023
- Original description
This clinical study evaluates the efficacy and safety of maintenance therapy with BCL-2 inhibitors in elderly patients with acute myeloid leukemia (AML) in first complete remission.Read full original descriptionShow less
Clinical Study Protocol of Maintenance Therapy With Venetoclax in Elderly Patients With Acute Myeloid Leukemia (AML) in First Complete Remission
This clinical study evaluates the efficacy and safety of maintenance therapy with BCL-2 inhibitors in elderly patients with acute myeloid leukemia (AML) in first complete remission.
This study involves the following content: BCL-2 inhibitors.
Inclusion: Patients with acute myeloid leukemia (AML) diagnosed based on bone marrow morphology and immunophenotyping (meeting the diagnostic criteria of WHO 2016); Achieving first complete remission (CR) or incomplete complete remission (CRi) after 1-2 cycles of induction therapy and receiving consolidation treatment for at least 4 cycles; Age between 60 and 85 years; Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3 times the upper limit of normal (ULN), serum bilirubin ≤ 1.5 times ULN, serum creatinine ≤ 2.0 times ULN, and serum creatine kinase < 2.0 times ULN; Left ventricular ejection fraction (LVEF) ≥ 50% as determined by echocardiography; Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. Obtaining informed consent from the patient or their legal representative.
Exclusion: Patients who achieve CR after relapse and re-induction therapy; Concurrent presence of other malignant tumors, except for the following conditions:; Patients who have received curative-intent treatment and have not had any known active disease of malignant tumors for ≥ 5 years before enrollment; Patients who have received adequate treatment and do not show signs of disease for non-melanoma skin cancer or malignant melanocytic nevi (even if it is within 3 years before randomization); Patients who have received adequate treatment and do not show signs of disease for in situ carcinoma (even if it is within 3 years before randomization); Any concurrent medical condition or disease (such as active systemic infection) that may interfere with the study procedures or results or pose risks to the participant as determined by the investigator.Inability to understand or comply with the study protocol; Undergoing major surgery within 4 weeks prior to randomization; Patients who have undergone allogeneic hematopoietic stem cell transplantation; Presence of organic heart disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction with clinical symptoms or cardiac dysfunction within the past 6 months (according to New York Heart Association functional classification NYHA ≥ 3); Patients with HIV/AIDS, syphilis, active hepatitis B (detectable HBV-DNA), and hepatitis C; Allergy to any of the drugs involved in the protocol. Pregnant or lactating women and reproductive-age patients who are unwilling to use contraception; Patients younger than 60 years or older than 85 years; Acute promyelocytic leukemia, myeloid sarcoma, blast phase of chronic myeloid leukemia; Extramedullary involvement of AML, including active central nervous system leukemia; Significant abnormalities in liver or kidney function beyond the inclusion criteria.