Trials / Completed
CompletedNCT02668653
Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 539 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a phase 3, randomized, double-blind, placebo-control global study. The purpose of this study is to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as continuation therapy for up to 36 cycles) on overall survival in subjects with FLT3-internal tandem duplication (ITD) positive AML.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Chemotherapy | |
| DRUG | Quizartinib | |
| DRUG | Placebo |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2021-08-13
- Completion
- 2023-06-16
- First posted
- 2016-01-29
- Last updated
- 2024-08-06
- Results posted
- 2022-10-05
Locations
244 sites across 28 countries: United States, Argentina, 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02668653. Inclusion in this directory is not an endorsement.