Clinical trial · Interventional
Clinical Study Protocol of IAV-induced Remission Followed by Consolidation Therapy With MDCyta+Ven in ND-AML
Clinical Study Protocol of Idarubicin, Cytarabine, and Venetoclax -Induced Remission Followed by Consolidation Therapy With Medium-dose Cytarabine Combined With Venetoclax in Newly Diagnosed Adult Acute Myeloid Leukemia
NCT06232694CI-TRIAL-00073488recruitingN/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)
This study evaluates the efficacy and safety of the combination of idarubicin and cytarabine induction followed by intermediate-dose cytarabine consolidation with venetoclax in the treatment of newly diagnosed adult acute myeloid leukemia (AML). This study includes the induction and consolidation phases of AML treatment.
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 |
|---|---|---|---|
| utologous stem cell transplantation (ASCT) /allogeneic hematopoietic stem cell transplantation (allo-HSCT). | Other | — | UNRESOLVED |
| Venetoclax : 100mg on day 1, 200mg on day 2, 400mg on days 3 to 8; oral administration; | Drug | — | UNRESOLVED |
| Venetoclax (Venetoclax): 400mg on day 1 to day 7; oral administration; | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induction therapy and consolidation therapy after remission
- description
- Induction therapy:Venetoclax + idarubicin + cytarabine Consolidation therapy after remission:Venetoclax + cytarabineIf The patient meets the criteria for autologous hematopoietic stem cell transplantation (ASCT) during the treatment process, they can undergo ASCT.If the patient meets the criteria for transplantation and there is a suitable donor, they can undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- interventionNames
- Drug: Venetoclax : 100mg on day 1, 200mg on day 2, 400mg on days 3 to 8; oral administration;
- Drug: Venetoclax (Venetoclax): 400mg on day 1 to day 7; oral administration;
- Other: utologous stem cell transplantation (ASCT) /allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Primary outcomes (1)
- measure
- The composite complete remission rate (CR+CRi)
- timeFrame
- Four months from the start of initial induction therapy.
- description
- Composite complete remission rate: the proportion of patients who achieve complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) at the end of induction therapy (CR+CRi).• CR is defined as meeting all of the following criteria: ① bone marrow blasts \<5%, no circulating or Auer rod blasts; ② no extramedullary disease; ③ ANC ≥1.0 × 109 /L; ④ platelet count ≥100 × 109 /L.• CRi is defined as PLT ≤100 × 109 /L and/or ANC ≤1.0 × 109 /L, with other criteria for CR being met.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed primary AML patients. Diagnostic criteria refer to the 2022 WHO classification. * Age between 18 and 60 years old. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix 2). * Cardiac ultrasound LVEF ≥ 45%. * Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured using a 24-hour urine sample). * Liver function: Aspartate aminotransferase (AST) ≤ 2.5 × ULN\*; Alanine aminotransferase (ALT) ≤ 2.5 × ULN\*; Total bilirubin ≤ 1.5 × ULN\* (\*unless considered due to leukemia infiltration). * Signed informed consent form. Exclusion Criteria: * Acute promyelocytic leukemia (APL). * Relapsed/refractory AML patients. * AML patients with known involvement of the central nervous system (CNS). * Known HIV-infected participants (due to potential drug-drug interactions between antiretroviral drugs and venetoclax). HIV testing will be conducted during screening according to local guidelines or institutional standards.Participants with positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Non-active carriers of viral hepatitis or participants with low viral hepatitis viral titers after receiving non-prohibited antiviral therapy will not be excluded. * Participants who have received strong or moderate CYP3A inducers/inhibitors therapy within 7 days prior to starting study treatment. * Participants with New York Heart Association (NYHA) functional classification \> Grade 2. Grade 2 is defined as patients having cardiac disease with no symptoms at rest but experiencing fatigue, palpitations, dyspnea, or angina with ordinary physical activity. * Participants with chronic respiratory disease requiring continuous oxygen therapy. * Patients unable to take oral medications or with malabsorption syndrome. * Presence of uncontrolled systemic infection (viral, bacterial, or fungal). * Participants who have previously received venetoclax treatment and/or are currently participating in any other study involving investigational drugs.
References
Publications (0)
Data not yet available
No reference posted for this study.