Clinical trial · Interventional
Venetoclax Combined With Homoharringtonine and Cytarabine in Induction for AML
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
NCT05805098CI-TRIAL-00065442VHArecruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Homoharringtonine | Drug | Omacetaxine Mepesuccinate | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Venetoclax Combined With Homoharringtonine and Cytarabine
- description
- All recipients in this arm received Venetoclax, Homoharringtonine and Cytarabine. Venetoclax was uesd as 100 mg on day 1, 200 mg on day 2, 400mg from day-3 to day-28. Homoharringtonine was uesd as 1 mg/m2 qd from day-1 to day-5. Cytarabine was uesd as 100 mg/m2 qd from day-1 to day-5.
- interventionNames
- Drug: Venetoclax
- Drug: Homoharringtonine
- Drug: Cytarabine
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- 28 days after study treatment
- description
- Defined as complete response (CR) + CR with incomplete blood count recovery (CRi) + morphologic leukemia-free state (MLFS) + partial response (PR).
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.