Potentially Curative Results for AML and High-Risk MDS with CLIA+Venetoclax

At the 66th annual American Society of Hematology (ASH) conferences, Dr. Tapan Kadia presented the promising results of a Phase II clinical trial investigating the combination of venetoclax with cladribine, cytarabine, and idarubicin in newly diagnosed acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) patients.

This innovative treatment regimen, aimed at improving response and survival rates, yielded impressive outcomes, including a 94% complete response rate and an overall survival rate of 73% in AML patients. The study highlights the potential of this combination therapy to offer durable remissions and facilitate transplants in eligible patients.

Learn More About the Therapies Used 

Cladribine helps increase the effectiveness of cytarabine in destroying abnormal cells. As a first-line AML treatment, cladribine, cytarabine, and idarubicine have an overall response rate of 85%. The overall survival rate is 1 year. 

Venetoclax is a BCL2 inhibitor that helps improve response and survival in patients with AML. When combined with azacitidine, it can induce remission in up to 66% of patients. The overall survival year is 14.7 months. 

This study enrolled patients with AML (95%), high-risk MDS (7%), they received six cycles of the following therapy: 

Induction

• Days 1-5: Cladribine 5mg, idarubicin 8-10 mg/m2, cytarabine 1-1.5 g/m2

• Days 2-8: venetoclax 400mg

Consolidation 

• Days 1-3: cladribine 5mg/m2, cytarabine 0.75-1.5 g/m2

• Days 1-2: idarubicin 8mg/m2 

• Days 2-8: venetoclax 400mg

Once patients achieved remission they received five additional cycles, with a median of 1-14 cycles to remission. 

The Study Results 

• The complete response rate of the combination of cladribine, cytarabine, and idarubicine with venetoclax was 94%. 

• 69% of patients could receive a transplant as this therapy offered high response rates and low mortality. 

• The overall survival (OS) was 73% in AML patients and 100% in MDS participants.

What Are the Study Conclusions? 

The combination of cladribine, cytarabine, and idarubicine with venetoclax is a highly effective, potentially curative regimen that produces durable remissions in newly diagnosed MDS and AML patients. A high response rate can facilitate patients’ receiving a transplant. 

Stay Tuned for More Updates! 

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Source: 

• A Phase II Trial of Venetoclax in Combination with Cladribine, Idarubicin, and Cytarabine in Newly Diagnosed Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome