Clinical trial · Observational
Venetoclax in Combination With Standard Induction and Consolidation Chemotherapy in Newly Diagnosed Young AML Patients
The Efficacy and Safety of Venetoclax in Combination With Standard Induction and Consolidation Chemotherapy in Newly Diagnosed Young Acute Myeloid Leukemia
- 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 observational study is to to evaluate the efficacy and safety of Venetoclax in combination with DA60(daunorubicin 60 mg/m2/d for 3 days, and cytarabine 100 mg/m2 every 12 h for 7 days) induction and HD-AraC(cytarabine 3 g/m2 every 12 h for 3 days) consolidation, in young patients with newly diagnosed acute myeloid leukemia (AML).
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease-free survival (DFS)
- timeFrame
- Assess up to 24 months.
- description
- DFS is calculated from the date of remission (inclusive of CR and CRi) to the date of relapse, death from any cause, or last follow-up.
Secondary outcomes (3)
- measure
- Complete remission (CR) rate
- timeFrame
- On Day 21 (window Day 21 to Day 35), a bone marrow aspirate specimen will be collected for morphology and pathology.
- description
- The rate of patient who get CR after induction therapy.
- measure
- Rate of minimal residual disease (MRD) negativity
- timeFrame
- MRD will be tested after every cycle of therapy and during follow-up.
- description
- Percentage of patients achieving CR with no evidence of MRD after induction therapy, 1 cycle of consolidation therapy, and 4 cycles of consolidation therapy. MRD negativity is defined as \< 0.1% of CD45 expressing cells with the target immunophenotype, or as cycling threshold (Ct) ≥ 40 in ≥ 2 of 3 replicates by qPCR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed, morphologically documented AML based on the World Health Organization (WHO) 2016 classification. * Age ≥ 18 years and ≤ 59 years * Have been treat with the "venetoclax in combination with standard induction and consolidation chemotherapy" therapy, and in follow-up. * Be comprehensive of the research, and able to provide informed consent. Exclusion Criteria: * Diagnosis of acute promyelocytic leukemia (APL). * Prior treatment for AML, except for: leukapheresis, hydroxyurea, and growth factor/cytokine. * Unable to understand or participate.
References
Publications (0)
Data not yet available