At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 61 enrolled
Drug / intervention
Venetoclax +1 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 Multicenter, Open-Label Phase 1b Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
In Brief
A Phase 1 clinical trial evaluating Venetoclax and Gilteritinib for Acute Myeloid Leukemia (AML). Completed, enrolled 61 participants across 11 sites.
Detailed Summary
A dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and efficacy of venetoclax, in combination with gilteritinib, in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) who have failed to respond to, and/or have relapsed or progressed after at least 1 prior therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia (AML)
CountriesUnited States
CollaboratorsAstellas Pharma Inc, Genentech, Inc.
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartOct 2018
Primary CompletionAug 2021
TodayJul 2026
First PostedAug 10, 2018
Enrollment StartOct 18, 2018
Primary CompletionAug 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.9 years ago
Interventions
Venetoclaxdrug
tablet, oral
Gilteritinibdrug
tablet, oral