NCT06635681RecruitingPhase 2
Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML
Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of Acute Myeloid Leukemia : a Multi-center, Single-arm Clinical Trial
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
Acute myeloid leukemia (AML) is a common hematological malignancy. Intensive chemotherapy is the main treatment in fit patients. Retrospective studies have shown that Venetoclax is highly effective in elder AML patients with IDH2 and NPM1 mutations while in those with TP53 and FLT3 mutations, the combination of azacitidine with Venetoclax showed an increased remission rate without improved survival. Since AML is a highly heterogeneous disease, it is not clear which genetic type of adult AML patients would benefit from Venetoclax combined with intensive chemotherapy. Therefore, this study intends to conduct a phase II clinical trial to investigate the efficacy of intensive chemotherapy combined with Venetoclax in adult AML patients, and reveal the efficacy of Venetoclax added to chemotherapy regimens for AML with different cytogenetic and molecular subgroups.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 380 (estimated)
- First submitted
- 27 Sept 2024
- Start date
- 29 Sept 2024
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT06635681
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 380
- From 29 Sept 2024 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent malignant tumors of other organs (those requiring treatment).
Other illness
- Active heart disease, defined as one or more of the following:
- A history of uncontrolled or symptomatic angina;
- Myocardial infarction less than 6 months after enrollment;
- Have a history of arrhythmia requiring drug treatment or severe clinical symptoms;
- Uncontrolled or symptomatic congestive heart failure (\> NYHA level 2);
- Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).
Other
- Subjects who meet any of the following criteria are excluded from the study:
- Acute promyelocytic leukemia with PML-RARA fusion gene
- Acute myeloid leukemia with BCR-ABL fusion gene
- Treated patients (but can receive hydroxyurea or cytarabine to the lower tumor burden).
- Those who were not considered suitable for inclusion by the researchers.
Who the study is looking for
- Patients who meet AML according to WHO (2022) or AML and MDS/AML defined by ICC standards.
- Age ≥14 years old, ≤ 60 years old, male or female.
- The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.
- Fulfill the requirements of the following laboratory tests (performed within 7 days prior to treatment) :
- Total bilirubin ≤ 1.5 times the upper limit of normal value (same age);
- AST and ALT≤ 2.5 times the upper limit of normal value (same age);
- Blood creatinine \< 2 times the upper limit of normal (same age);
- Myocardial enzymes \< 2 times the upper limit of normal (same age);
- Left ventricular ejection fraction \>50% by measure of echocardiogram (ECHO). Informed consent must be signed before the commencement of all specific study procedures, and signed by the patient himself or his immediate family. Considering the patient\'s condition, if the patient\'s signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient\'s immediate family.
Age in the registry: 14 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Blood Diseases Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.