Clinical trial · Interventional
Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Young Treatment-naive Acute Myeloid Leukemia: a Multicenter, Phase II Study
- 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 investigate the safety and efficacy of drug "X" in combination with intensive chemotherapy in subjects with newly diagnosed AML (excluding APL and CBF-AML). "X" drugs included BCL-2 inhibitor venetoclax and FLT3 inhibitor Gilteritinib. Subjects will receive standard intensive chemotherapy during induction and consolidation. Early induction response will be evaluated according to the results of peripheral blood blast clearance rate on the fifth day after induction therapy (D5-PBCR). Venetoclax will be added in D5-PBCR positive subjects. For subjects with FLT3 mutations, Gilteritinib will be combined. Subjects will be stratified based on the genetic risk classification of 2022 European LeukemiaNet recommendations (ELN risk) and MRD status to receive specific consolidation therapy after the induction therapy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D5-PBCR(-) IA arm | Drug | — | UNRESOLVED |
| D5-PBCR(+) IA+Venetoclax arm | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- D5-PBCR(-)
- description
- On day five of IA induction, D5-PBCR will be tested according to protocol. For D5-PBCR (-) patients, no additional of venetoclax is needed.
- interventionNames
- Drug: D5-PBCR(-) IA arm
- type
- EXPERIMENTAL
- label
- D5-PBCR(+)
- description
- On day five of induction, D5-PBCR will be tested according to protocol. D5-PBCR (+) patients, will receive induction therapy consisting of venentoclax combined with IA regimen.
- interventionNames
- Drug: D5-PBCR(+) IA+Venetoclax arm
Primary outcomes (1)
- measure
- Composite complete remission rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: 1. Bone marrow morphology and immunology confirmed newly diagnosed AML patients (according to 2022 ICC criteria) 2. Exclude patients with APL and CBF-AML (according to fusion genes and chromosomes) 3. Performance status score 0-2 (ECOG score) 4. Age 18\~59 years old 5. Liver and kidney function: blood bilirubin ≤ 35 μmol/L, AST/ALT below 2 times the upper limit of normal, creatinine ≤ 150 μmol/L 6. Normal cardiac function (EF ≥50%) 7. Obtained informed consent signed by the patient or family member Exclusion Criteria: 1. FAB classification is M3, or confirmed APL at the molecular level 2. CBF-AML 3. Patients who have already been treated 4. Comfirmed central nervous system leukemia 5. Allergy to any of the drugs involved in the protocol 6. Medical condition or organ system dysfunction that precludes the inability to swallow capsules or tablets, or has a disease that significantly affects gastrointestinal function and/or inhibits small bowel absorption (including malabsorption syndrome, small bowel resection, or poorly controlled inflammatory bowel disease) 7. Cardiac function and disease consistent with one of the following: a) long QTc syndrome or QTc interval \>480 ms; b) second- or third-degree atrioventricular block; Severe, uncontrolled cardiac arrhythmias requiring medication; c) United States New York College of Cardiology Grade ≥ III; d) Ventricular ejection fraction (LVEF) less than 50%; e) History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically severe pericardial disease, or ECG evidence of acute ischemic or active conduction abnormalities within 6 months prior to recruitment 8. Previous or present concomitant malignancies (except for basal cell carcinoma of the skin that have been effectively controlled as non-melanoma, carcinoma in situ of the breast/cervix, and other malignancies that have not been effectively controlled for more than 6 months, and patients who have been receiving long-term non-chemotherapy treatments such as hormonal therapy) 9. Significant abnormalities in liver and kidney function (serum bilirubin, aspartate aminotransferase, alanine aminotransferase or serum creatinine more than 2 times the upper limit of normal reference values; Excluded from AML-related as judged by the investigator) 10. Patients who have previously used other drugs for the treatment of AML (except hydroxyurea and cytarabine for cell count control), including but not limited to BCL2, FLT3, IDH1, IDH2 inhibitors, or other drugs in clinical trials 11. Coagulopathy not associated with AML 12. HIV infection, syphilis infection, HCV infection, active HBV infection (HBsAg positive, or HBsAg negative but HBcAb positive with HBV DNA \> 1.0 ×ULN) 13. Other uncontrolled active infection (as judged by the investigator) 14. Pregnant or lactating women 15. Inability to understand or follow the study protocol 16. Participation in other relevant clinical studies within 30 days (except diagnostic clinical studies) 17. Patients who in the opinion of the investigator, are not suitable to participate in this study
References
Publications (2)
- BACKGROUNDZhang Y, Li X, Weng X, Shen Y, Chen Y, Zheng Y, Zhao H, You J, Mao Y, Wang L, Wu M, Sheng Y, Wu J, Hu J, Chen Q, Li J. Optimization of idarubicin and cytarabine induction regimen with homoharringtonine for newly diagnosed acute myeloid leukemia patients based on the peripheral blast clearance rate: A single-arm, phase 2 trial (RJ-AML 2014). Am J Hematol. 2022 Jan 1;97(1):43-51. doi: 10.1002/ajh.26386. Epub 2021 Nov 1. PMID 34687467
- BACKGROUNDYu C, Kong QL, Zhang YX, Weng XQ, Wu J, Sheng Y, Jiang CL, Zhu YM, Cao Q, Xiong SM, Li JM, Xi XD, Chen SJ, Chen B. Clinical significance of day 5 peripheral blast clearance rate in the evaluation of early treatment response and prognosis of patients with acute myeloid leukemia. J Hematol Oncol. 2015 May 10;8:48. doi: 10.1186/s13045-015-0145-1. PMID 25957890