At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 539 enrolled
Drug / intervention
Chemotherapy +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 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)
In Brief
A Phase 3 clinical trial evaluating Chemotherapy, Quizartinib, and 1 other intervention for Acute Myeloid Leukemia and Leukemia. Completed, enrolled 539 participants across 244 sites in 28 countries.
Detailed Summary
Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Leukemia
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartSep 2016
Primary CompletionAug 2021
Study CompletionJun 2023
TodayJul 2026
First PostedJan 29, 2016
Enrollment StartSep 1, 2016
Primary CompletionAug 13, 2021
Study CompletionJun 16, 2023
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 10.4 years ago
Interventions
Chemotherapydrug
Quizartinibdrug
Placebodrug