Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia

Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia: A Prospective, Randomized, Controlled Study

Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia (NCT07512700) is a Phase 2 interventional studying Acute Monocytic Leukemia, sponsored by Chinese PLA General Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Acute Monocytic 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.

Target enrollment of 204 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Acute Monocytic Leukemia subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Voluntary participation with written willing to sign a consent form signed by the participant or a legal guardian; willingness to comply with all study procedures. - Age 14 to 60 years at screening, no gender restriction. - Diagnosis of acute monocytic leukemia according to the 2016 WHO classification, excluding acute promyelocytic leukemia. - No history of severe allergic reactions. - Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN. - Renal function: serum creatinine ≤ 1.5 × ULN - No uncontrolled infection or severe psychiatric disorder. - You should be able to carry out daily activities with 0 level of ability (ECOG 0)-3; life expectancy ≥ 4 months. Who Should NOT Join This Trial: - Known hypersensitivity or contraindication to any study drug. - Pregnancy or lactation. - Active infection. - Long-term smoking or alcohol abuse that may interfere with study outcome evaluation. - Psychiatric illness or other condition that prevents willing to sign a consent form or compliance with study procedures. - Major organ surgery within 6 weeks prior to enrollment. - Abnormal liver function: total bilirubin \> 2× ULN, ALT/AST \> 2.5 × ULN; abnormal renal function: serum creatinine \> 1.5 × ULN. - Any condition deemed unsuitable for the study by the investigator (e.g., poor compliance, substance abuse). 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: * Voluntary participation with written informed consent signed by the participant or a legal guardian; willingness to comply with all study procedures. * Age 14 to 60 years at screening, no gender restriction. * Diagnosis of acute monocytic leukemia according to the 2016 WHO classification, excluding acute promyelocytic leukemia. * No history of severe allergic reactions. * Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN. * Renal function: serum creatinine ≤ 1.5 × ULN * No uncontrolled infection or severe psychiatric disorder. * ECOG performance status 0-3; life expectancy ≥ 4 months. Exclusion Criteria: * Known hypersensitivity or contraindication to any study drug. * Pregnancy or lactation. * Active infection. * Long-term smoking or alcohol abuse that may interfere with study outcome evaluation. * Psychiatric illness or other condition that prevents informed consent or compliance with study procedures. * Major organ surgery within 6 weeks prior to enrollment. * Abnormal liver function: total bilirubin \> 2× ULN, ALT/AST \> 2.5 × ULN; abnormal renal function: serum creatinine \> 1.5 × ULN. * Any condition deemed unsuitable for the study by the investigator (e.g., poor compliance, substance abuse).

Treatments Being Tested

DRUG

CACAG+VEN

Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor 1. Azacytidine (75 mg/m2/day, days 1 to 7). 2. Cytarabine (75-100 mg/m2 every 12 hrs, days 1 to 5). 3. Aclacinomycin (20 mg/day, days 1,3,5). 4. Chidamide (30 mg/day , days 1,4,8,11). 5. Venetoclax is administered orally with a dose ramp-up schedule: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3 through 14. If an azole antifungal agent is co-administered, the dose of venetoclax is reduced to 100 mg daily. 6.Granulocyte colony-stimulating factor (G-CSF) is given subcutaneously at 300 μg per day until neutrophil recovery.

DRUG

3+7

IA regimen: 1. Idarubicin (8-10 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. DA regimen: 1.Daunorubicin(60 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. MA regimen: 1.Mitoxantrone (12 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.

Locations (3)

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.

Air Force Medical Center, PLA

Beijing, China

Chinese PLA General Hospital

Beijing, China

PLA Strategic Support Force's Characteristic Medical Center

Beijing, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07512700), the sponsor (Chinese PLA General Hospital), 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 NCT07512700 clinical trial studying?

This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07512700?

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 NCT07512700?

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 NCT07512700. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07512700. 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.