Combining venetoclax and azacitidine with HAAG for treating newly diagnosed AML

A Single-center, Single-arm, Prospective Clinical Study on the Efficacy and Safety of Venetoclax and Azacitidine Combined With HAAG in the Induction Treatment of Intermediate and High-risk Acute Myeloid Leukemia

This study is testing a new combination of medications for people who have just been diagnosed with intermediate and high-risk acute myeloid leukemia to see if it helps them respond better to treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06394011 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a treatment regimen combining venetoclax and azacitidine with HAAG in patients newly diagnosed with intermediate and high-risk acute myeloid leukemia (AML). It is a single-center, single-arm, prospective study that aims to provide an effective induction treatment for these patients. Participants will receive the combined therapy and will be monitored for treatment outcomes and safety profiles.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with newly diagnosed intermediate or high-risk AML who have not received prior chemotherapy or targeted therapy.

Not a fit: Patients with acute promyelocytic leukemia or those with significant cardiovascular dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with newly diagnosed intermediate and high-risk AML.

How similar studies have performed: While this approach is promising, it is not widely tested, making it a novel intervention in this specific patient population.

Eligibility criteria

Inclusion Criteria:

1. Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).
2. Age 18-65.
3. ECOG score: 0-2.
4. No history of previous chemotherapy or target therapy.
5. Serum total bilirubin \<= 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) \<= 1.5 times ULN, aspartate aminotransferase (AST) \<=1.5 times ULN;
6. Creatinine clearance rate \>=30 mL/min;
7. Serum lipase \<= 1.5 times ULN, amylase \<= 1.5 times ULN;
8. Capable to understand and willing to participate in this study, signed the informed consent form.

Exclusion Criteria:

1. AML transformed with chronic myelogenous leukemia.
2. Acute promyelocytic leukemia (type M3).
3. Patients with a second malignancy requiring treatment.
4. Patients with uncontrolled active infection.
5. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
6. Patients with hepatic and renal inadequacy: total serum bilirubin \>=2.0 mg/dl, AST \>=3 times ULN, serum creatinine clearance (Ccr) \<50 ml / min.
7. Patients with arterial oxygen saturation (SpO 2) was \<95%.
8. Patients with HIV infection.
9. Patients with active hepatitis B or hepatitis C infection.
10. Patients with other commodities that the investigators considered not suitable for the enrollment.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Xiaowen Tang, Ph.D

Conditions Intermediate Risk Acute Myeloid Leukemia; High Risk Acute Myeloid Leukemia