Combining venetoclax with homoharringtonine and cytarabine for treating acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Qiu Huiying
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Huiying Qiu, PhD
• Email: qiuhuiying@aliyun.com
• Phone: 13912792913

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.