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Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML

StatusActive, Not Recruiting
PhasePhase 3
Started2017-02-08
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

2025-05-26
Recruiting→Active, Not Recruiting Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-12→2026-05-15
Completion date2024-12→2027-10-15
Study sitesdetails revised at 1 of 1 site
2023-10-03
Study Status, Study Design v4
Primary completion date2021-12→2024-12
Completion date2022-12→2024-12
Enrollment target1000→1100
2019-03-21
2 amendments v2-v3
2 re-verifications since 2017-04-23, no change to tracked fields
2017-02-28
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2017-01→2017-02-08
Study sitesdetails revised at 1 of 1 site
2017-01-12
Original filing
In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine. In the control arm, patients receive DA regimen with standard dose of cytarabine.The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.
Trial Details
NCT Number NCT03021330
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions AML
Enrollment 1,100 participants
Start Date 2017-02-08
Primary Completion 2026-05-15 (estimated)
Study Completion 2027-10-15 (estimated)
Updated on ClinicalTrials.gov 2025-05-30