Combining Venetoclax with CACAG regimen for treating relapsed/refractory acute myeloid leukemia

A Prospective,Randomized,and Comparative Study on the Efficacy of Venetoclax Combined With CACAG Regimen and BAT Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

This study is testing a new treatment that combines venetoclax with a specific drug regimen to see if it helps people with relapsed or refractory acute myeloid leukemia feel better compared to the best available therapy.

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 Municipality)
• Trial ID: NCT06084819 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 the CACAG regimen, which includes azacitidine, cytarabine, aclarubicin, chidamide, and G-CSF, in patients with relapsed or refractory acute myeloid leukemia (AML). The study compares this combination to the Best-Available Therapy (BAT) to determine which approach yields better outcomes for patients. Given the poor prognosis associated with relapsed/refractory AML, this study seeks to explore innovative treatment options that may improve survival rates and response to therapy.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 14 to 75 years with relapsed or refractory acute myeloid leukemia who meet specific health criteria.

Not a fit: Patients with known allergies to the study drugs, pregnant or breastfeeding women, and those with severe organ dysfunction or uncontrolled infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with relapsed/refractory acute myeloid leukemia.

How similar studies have performed: Other studies have shown promising results with similar combinations of venetoclax and hypomethylating agents, indicating potential for success in this novel approach.

Eligibility criteria

Inclusion Criteria:

* Patients who are able to understand and willing to sign the informed consent form (ICF).
* All patients should aged 14 to 75 years,no gender limitation.
* Patients with R/R AML, diagnosed in accordance with the 2021 edition of the CMA criteria
* 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 Municipality

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

Study contacts

• Study coordinator: Daihong Liu, doctor

Conditions: Relapsed/Refractory Acute Myeloid Leukemia