Tests venetoclax with two chemotherapy drugs in newly diagnosed acute myeloid leukemia
Tests venetoclax with homoharringtonine and cytarabine in adults newly diagnosed with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Venetoclax Combined With Homoharringtonine and Cytarabine in Induction for AML
Key facts
- Where
- Suzhou, ChinaSee the site
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged over 18 up to 60 with newly diagnosed acute myeloid leukemia (AML) who have not been treated before and can have intensive chemotherapy.
- Age
- Over 18 to 60 years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed acute myeloid leukemia (AML) confirmed by WHO criteria. Acute promyelocytic leukemia (M3) is not included.
- Earlier treatment
- Previously untreated for AML. Hydroxyurea is permitted to bring the white blood cell count under 25 × 109 /L.
Main reasons for not taking part
- Acute promyelocytic leukemia (M3)
- Infection that is not controlled, or active bleeding from vital organs
- Uncontrolled HIV infection or active hepatitis B or C
- Pregnant or breast feeding, or able to have children without a negative urine pregnancy test
- Drug or alcohol abuse that would affect the study, or another medical or psychiatric history the investigator judges a problem
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT05805098, who can take part
Where in China
- Qiu huiyingSuzhou, ChinaContact: Huiying Qiu, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT05805098
- Record updated
- 7 April 2023
- Original description
This study aims to evaluate the efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of newly diagnosed acute myeloid leukemia.Read full original descriptionShow less
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 aims to evaluate the efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of newly diagnosed acute myeloid leukemia.
Inclusion: 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; 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; Patients > 18 to ≤ 60 years; Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2; 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: Patient is ineligible for treatment with intensive chemotherapy; Patient with active infection not controlled, active bleeding from vital organs; Patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study; Patient has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study; Patients with uncontrolled infection with human immunodeficiency virus (HIV) or active Hepatitis B or C; > 60 years of age or <18 years of age; Acute promyelocytic leukemia (M3); Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen; Patients deemed unsuitable for enrolment by the investigator.