Combining venetoclax with homoharringtonine and cytarabine for treating acute myeloid leukemia

Venetoclax in Combination With Homoharringtonine and Cytarabine in Newly Diagnosed Subjects With Acute Myeloid Leukemia: a Phase 2/3, the Single-arm, Open-label, Monocentric Study

This study is testing a new combination of three medications to see if it can help younger adults with newly diagnosed acute myeloid leukemia feel better and improve their chances of recovery.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT05805098 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of a combination treatment using venetoclax, homoharringtonine, and cytarabine for patients aged 18-60 with newly diagnosed acute myeloid leukemia (AML). It is a phase II/III interventional study designed to improve outcomes for patients who have not received prior treatment for AML. Participants will receive the combination therapy and may continue treatment based on their recovery status, with follow-up assessments occurring every 3 to 6 months for up to 2 years after treatment completion.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 who have been newly diagnosed with acute myeloid leukemia and are eligible for intensive chemotherapy.

Not a fit: Patients with significant comorbidities or those who have received prior treatment for AML may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and outcomes for patients with acute myeloid leukemia.

How similar studies have performed: Other studies have shown promising results with similar combination therapies in treating acute myeloid leukemia, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
2. patients must have confirmation of AML by WHO criteria, previously untreated, and eligible for treatment with intensive chemotherapy as defined by the following: Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%. Creatinine clearance \< 45 mL/min. Moderate hepatic impairment with total bilirubin \> 1.5 × ULN. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.
3. Patients \> 18 to ≤ 60 years
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2
5. Laboratory values meeting the following criteria:Creatinine clearance ≥ 45 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection, Serum aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN) 、Serum alanine aminotransferase (ALT) ≤ 3.0 × ULN (Unless considered due to leukemic organ involvement), Total bilirubin ≤ 1.5 × ULN, White blood cell (WBC) count \< 25 × 109 /L (hydroxyurea is permitted to meet this criterion)

Exclusion Criteria:

1. \> 60 years of age or \<18 years of age
2. Acute promyelocytic leukemia (M3)
3. Patient is ineligible for treatment with intensive chemotherapy
4. Patient with active infection not controlled, active bleeding from vital organs
5. Patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study
6. Patient has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study.
7. Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen.
8. Patients with uncontrolled infection with human immunodeficiency virus (HIV) or active Hepatitis B or C
9. Patients deemed unsuitable for enrolment by the investigator.

Where this trial is running

Suzhou, Jiangsu

• Qiu Huiying — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Huiying Qiu, PhD

Conditions Acute Myeloid Leukemia