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

Efficacy of Venetoclax Combined with Intensive Chemotherapy in Different Subgroups of AML (NCT06635681) is a Phase 2 interventional studying AML (Acute Myelogenous Leukemia), sponsored by Institute of Hematology & Blood Diseases Hospital, China. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against AML (Acute Myelogenous Leukemia) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 1,200 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 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). willing to sign a consent form 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 willing to sign a consent form shall be signed by the legal guardian or the patient\'s immediate family. Who Should NOT Join This Trial: 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). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

combined chemotherapy

Induction therapy(1 cycle): Daunorubicin 60mg/m2/d d1-3 Cytarabine 100mg/m2/d d1-7 Venetoclax 100mg d-2, 200mg d-1, 400mg d1-7 If the first course of treatment did not result in CR, patients with therapeutic target could be treated with targeted drugs, and the patients without targets would be treated with HAV regimen: Cytarabine 100mg/m2/d, d1-5, Homoharringtonine 2mg/m2 d1-5, Venetoclax 100mg d-2, 200mg d-1, 400mg d1-7. Consolidation therapy(3 cycles): Cytarabine 2g/m2 q12h d1-3 Venetoclax 400mg d1-7 For patients with CBF and CEBPA dual mutations, the dose of cytarabine is 3g/m2. Maintenance treatment(6 cycles): Azacitidine 75mg/m2/d d1-5 Venetoclax 400mg d1-7 Allogeneic hematopoietic stem cell transplantation is recommended for high-risk groups and intermediate-risk with positive measurable residual disease.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06635681), the sponsor (Institute of Hematology & Blood Diseases Hospital, China), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06635681 clinical trial studying?

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 in… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06635681?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06635681?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06635681. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06635681. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.