NCT06635681 Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML
| NCT ID | NCT06635681 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | AML (Acute Myelogenous Leukemia) |
| Study Type | INTERVENTIONAL |
| Enrollment | 380 participants |
| Start Date | 2024-09-29 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 380 participants in total. It began in 2024-09-29 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients who meet AML according to WHO (2022) or AML and MDS/AML defined by ICC standards. 2. Age ≥14 years old, ≤ 60 years old, male or female. 3. The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points. 4. Fulfill the requirements of the following laboratory tests (performed within 7 days prior to treatment) : 1. Total bilirubin ≤ 1.5 times the upper limit of normal value (same age); 2. AST and ALT≤ 2.5 times the upper limit of normal value (same age); 3. Blood creatinine \< 2 times the upper limit of normal (same age); 4. Myocardial enzymes \< 2 times the upper limit of normal (same age); 5. 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. Exclusion Criteria: Subjects who meet any of the following criteria are excluded from the study: 1. Acute promyelocytic leukemia with PML-RARA fusion gene 2. Acute myeloid leukemia with BCR-ABL fusion gene 3. Treated patients (but can receive hydroxyurea or cytarabine to the lower tumor burden). 4. Concurrent malignant tumors of other organs (those requiring treatment). 5. Active heart disease, defined as one or more of the following: 1. A history of uncontrolled or symptomatic angina; 2. Myocardial infarction less than 6 months after enrollment; 3. Have a history of arrhythmia requiring drug treatment or severe clinical symptoms; 4. Uncontrolled or symptomatic congestive heart failure (\> NYHA level 2); 6. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis). 7. Those who were not considered suitable for inclusion by the researchers.
Contact & Investigator
Hui Wei, MD
PRINCIPAL INVESTIGATOR
Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Frequently Asked Questions
Who can join the NCT06635681 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 60 Years, studying AML (Acute Myelogenous Leukemia). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06635681 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06635681 currently recruiting?
Yes, NCT06635681 is actively recruiting participants. Contact the research team at weihui@ihcams.ac.cn for enrollment information.
Where is the NCT06635681 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06635681 clinical trial?
NCT06635681 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Hui Wei, MD at Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College. The trial plans to enroll 380 participants.
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