At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Alvocidib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open-label, Dose-escalation, Safety and Biomarker Prediction of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
In Brief
A Phase 1 clinical trial evaluating Alvocidib, Cytarabine, and 1 other intervention for Acute Myeloid Leukemia. Completed, enrolled 32 participants across 3 sites.
Detailed Summary
The purpose of this Phase I study is to determine the safety and tolerability including the maximum dose (MTD) and dose-limiting toxicities (DLTs) of alvocidib when administered over a range of doses on Days 1-3 followed by cytarabine/daunorubicin (7+3) on Days 5-11 in adults with newly diagnosed and previously untreated AML
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartSep 2017
First PostedOct 2017
Primary CompletionMar 2020
TodayJul 2026
First PostedOct 2, 2017
Enrollment StartSep 25, 2017
Primary CompletionMar 20, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 8.8 years ago
Interventions
Alvocidibdrug
IV bolus followed by IV infusion
Cytarabinedrug
continuous infusion
Daunorubicindrug
IV bolus