Clinical trial · Interventional
Study on Optimizing the Treatment of Patients With Acute Myeloid Leukemia Based on Early Peripheral Blood Minimal Residual Disease
A Multicenter, Open-label, Prospective, Randomized Controlled Study to Optimize the Treatment of Patients With Acute Myeloid Leukemia Based on Early Peripheral Blood Minimal Residual Disease
NCT07023588CI-TRIAL-00093299recruitingPhase 2ClinicalTrials.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)
A multicenter, open-label, prospective, randomized controlled study to optimize the treatment of patients with acute myeloid leukemia based on early peripheral blood minimal residual disease
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 (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- venetoclax,8-14d
- interventionNames
- Drug: Venetoclax
- type
- NO_INTERVENTION
- label
- Control group
Primary outcomes (1)
- measure
- Modified Composite Complete Response Rate(mCRc)
- timeFrame
- Through study completion, an average of 1 year
- description
- Complete Response(CR) + Complete Response with Incomplete Hematologic Recovery(CRi)+Morphologic Leukemia Free State(MLFS)
Secondary outcomes (3)
- measure
- Overall Survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed AML patients confirmed by bone marrow morphology and immunophenotyping. 2. Complete MICM (Morphology, Immunophenotyping, Cytogenetics, Molecular genetics) work-up. 3. Age ≥ 18 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. Day 6 Peripheral Blood Blast Percentage (D6PBBP) ≥ 1%. 6. Renal function with creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured by 24-hour urine collection). 7. Liver function with Aspartate Aminotransferase (AST) ≤ 2.5 × ULN\*; Alanine Aminotransferase (ALT) ≤ 2.5 × ULN\*; Total bilirubin ≤ 1.5 × ULN\* (\*Unless considered due to leukemia infiltration). 8. Patients deemed suitable to receive DA/IA therapy by the investigator. 9. Signed informed consent form. - Exclusion Criteria: 1. Acute promyelocytic leukemia (APL). 2. Mixed phenotype acute leukemia (MPAL). 3. AML patients with known central nervous system (CNS) involvement. 4. Presence of extramedullary disease (EMD). 5. Significant hepatic or renal dysfunction exceeding the inclusion criteria limits. 6. Severe cardiac disease, including congestive heart failure, myocardial infarction, or cardiac dysfunction. 7. Concurrent active malignancy of other organ systems (patients with a history of cured malignancy may be eligible). 8. Active tuberculosis or HIV-positive patients. 9. Concurrent other hematological disorders. 10. Pregnant or lactating women. 11. Inability to comprehend or comply with the study protocol. 12. Hypersensitivity to any component of the drugs involved in the protocol. 13. Inability to take oral medication or patients with malabsorption syndrome. 14. Uncontrolled systemic infection. 15. Prior venetoclax treatment and/or current participation in any other study involving investigational agents.
References
Publications (0)
Data not yet available
No reference posted for this study.