Combining Venetoclax with CACAG regimen for treating newly diagnosed Acute Myeloid Leukemia

Multicenter,Open Label,Phase 2 Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

This study is testing if a new treatment combining venetoclax with CACAG can help people aged 14 to 75 with newly diagnosed acute myeloid leukemia feel better compared to the standard treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 14 Years to 75 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06068621 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the efficacy and safety of a new treatment regimen combining venetoclax with CACAG against the traditional '3+7' regimen for patients with newly diagnosed acute myeloid leukemia (AML). The study will involve patients aged 14 to 75 who meet specific health criteria and have not previously received treatment for AML. By comparing these two approaches, the study seeks to determine if the new combination can improve patient outcomes in terms of response rates and safety profiles.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 14 to 75 who have newly diagnosed AML and meet specific health criteria.

Not a fit: Patients with severe allergies to the study drugs, pregnant or breastfeeding women, and those with a history of substance abuse may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective option for patients with newly diagnosed acute myeloid leukemia, potentially improving survival rates.

How similar studies have performed: While the traditional '3+7' regimen has been widely used, the combination of venetoclax with CACAG is a novel approach that has not been extensively tested in previous studies.

Eligibility criteria

Inclusion Criteria:

Patients who are able to understand and willing to sign the informed consent form (ICF).

* All patients should aged 14 to75 years,no gender limitation.
* Patients who are newly diagnosed with AML(no M3).
* Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal;
* Renal function: creatinine ≤the upper limit of normal;
* Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
* The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months.
* Patients without severe allergic constitution.

Exclusion Criteria:

* Patients with allergy or contraindication to the study drug;
* Female patients who are pregnant or breast-feeding.
* Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment;
* Patients with mental illness or other states unable to comply with the protocol;
* Less than 6 weeks after surgical operation of important organs.
* Liver function: ALT and AST\>2.5 times the upper limit of normal ,bilirubin\> 2 times the upper limit of normal;Renal function: creatinine \>the upper limit of normal;
* The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)

Where this trial is running

Beijing, Beijing

• Chinese PLA General Hospital — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Daihong Liu, doctor

Conditions: Acute Myeloid Leukemia, First Line Therapy