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Intensive Therapy Combined With Venetoclax for Adult Acute Myeloid Leukemia

StatusActive, Not Recruiting
PhasePhase 2/3
Started2022-05-19
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 30, 2025 (before its estimated May 15, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-05-28
notable
Not Yet Recruiting→Active, Not Recruiting Study Identification, Study Status, Study Design, Contacts/Locations v1
Trial statusNot Yet Recruiting→Active, Not Recruiting
Primary completion date2024-06→2026-05-15
Completion date2027-06→2027-10-15
Start dateestimated 2022-06→confirmed 2022-05-19
Enrollment targetestimated 300→confirmed 312
Study sites0→1
2022-04-29
minor
Original filing
300 patients will be randomly distributed into the control group (n=150) and the experimental group(n=150). Patients will receive two cycles of induction chemotherapy. The control group receives standard 3+7 induction regimen containing cytarabine (100mg/m2 d1-7) and daunorubicin (60mg/m2 d1-3). The experimental group receives venetoclax combined with intensive chemotherapy (3+7 induction regimen same as the control group). For each group, patients who fail to achieve CR/CRi after two courses of induction therapy may receive alternative therapy decided by their physicians. After CR/CRi achieved, subjects proceed allo-transplantation or consolidation therapy according to their ELN risks: subjects in favorable risk group should continue with chemotherapy; subjects in poor risk group should go through transplantation; for subjects in intermediate risk group, those with suitable donors can receive transplantation while others can continue with consolidation therapy. Subjects receive 3 courses of intermediate-dose cytarabine (1.5g/m2 q12h d1, 3, 5) for age\>55 years or high dose cytarabine (3g/m2 q12h d1, 3, 5) for age≤ 55 years as consolidation therapy with venetoclax in experimental group and without venetoclax in control group. After consolidation, patients will be observed.
Trial Details
NCT Number NCT05356169
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions Acute Myeloid Leukemia
Enrollment 312 participants
Start Date 2022-05-19
Primary Completion 2026-05-15 (estimated)
Study Completion 2027-10-15 (estimated)
Updated on ClinicalTrials.gov 2025-05-30