Clinical trial · Interventional
Single Arm Study of Azacitidine and Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients
To Evaluate Safety and Efficacy of Azacitidine Combination With Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients:A Multicenter, Single-arm Study
NCT05471700CI-TRIAL-00095631completedN/AClinicalTrials.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)
The goal of this clinical research study is to evaluate the safety and efficacy of Azacytidine in combination with Venetoclax in patients with newly diagnosed fit 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 |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Azacitidine combined with Venetoclax
- description
- Each course is 28 days long. Subjects with newly diagnosed AML receive Venetoclax once daily by oral. The doses of Venetoclax is 100 mg on Day 1, 200 mg on Day 2, reaching a target dose of 400 mg on Day 3 and continuing through Day 28. If concomitantly receiving azoles, the dose of Venetoclax will be adjusted according to the instructions. At the same time patients will receive Azacitidine 75mg/m2 subcutaneous on Days 1-7.The induction therapy includes 1-2 cycle until subjects get remission. Once complete remission, subjects will receive consolidation. Azacitidine combined with Venetoclax or middle to high dose of arabinoside based chemotherapy would be given at the discretion of the physician.
- interventionNames
- Drug: Azacitidine
- Drug: Venetoclax
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Up to 36 months
- description
- ORR is defined as the percentage of participants who achieve the CR + CRi + Partial Remission (PR) as evaluated by the investigator.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 1.Age 45 to 65 years old,both male and female * 2.Be able to understand and sign informed consent * 3.Untreated AML patients (non-APL) diagnosed according to the 2016 World Health Organization (WHO) classification and diagnostic criteria for acute myeloid leukemia * 4.Patients with an ECOG performance status 0,1,2 or 3 * 5.Expected survival time≥3 months * 6.Laboratory indicators meet the following standards: 1. Bilrubin, ALT and AST were all less than 3 times the upper limit of normal within 7 days before the first day of treatment 2. Serum creatinine clearance rate is greater than 30ml/min Exclusion Criteria: * 1.patients participating in other interventional or observational clinical studies currently * 2.Patients has a history of myeloproliferative neoplasm \[MPN\] * 3.Patients with acute promyelocytic leukemia * 4.Active CNS involvement in patients with acute myeloid leukemia * 5.Patients with active hepatitis B or C, HIV infection before enrollment * 6.Cardiovascular status of patients evaluate by NYHA classification method \> 2 * 7.Patients have chronic respiratory disease requiring continuous oxygen treatment, or any sitiuation investigator believes will adversely affect this study (including renal, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular disease and known history of allergy to any study drug) * 8.Patients suffering from malabsorption syndrome or other diseases that prevent the enteral route of administration * 9.patients present with an uncontrolled systemic infection (viral, bacterial, or fungal) * 10.Patients with a history of other malignancies within 2 years before enrollment, except for the following cases: 1. Adequately treated carcinoma in situ of the cervix or carcinoma of the breast 2. Basal cell carcinoma or localized squamous cell carcinoma of skin
References
Publications (0)
Data not yet available
No reference posted for this study.