Clinical Trial: NCT02668653
Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Daiichi Sankyo |
| Information Provided By: | Daiichi Sankyo |
| Last Update Posted: | 2024-08-06 |
Study Overview
Brief 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.
Official Title
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)
Conditions
Acute Myeloid Leukemia, Leukemia
Intervention / Treatment
- Drug: Chemotherapy
- Drug: Quizartinib
- Drug: Placebo
Other Study ID Numbers
- AC220-A-U302
- 2015-004856-24
- 173667
- 2015
Start Date (Actual)
2016-09-01
Primary Completion Date (Actual)
2021-08-13
Study Completion Date (Actual)
2023-06-16
Enrollment (Actual)
539
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Daiichi Sankyo |
| Information Provided By: | Daiichi Sankyo |
| Last Update Posted: | 2024-08-06 |
Study Overview
Brief 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.
Official Title
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)
Conditions
Acute Myeloid Leukemia, Leukemia
Intervention / Treatment
- Drug: Chemotherapy
- Drug: Quizartinib
- Drug: Placebo
Other Study ID Numbers
- AC220-A-U302
- 2015-004856-24
- 173667
- 2015
Start Date (Actual)
2016-09-01
Primary Completion Date (Actual)
2021-08-13
Study Completion Date (Actual)
2023-06-16
Enrollment (Actual)
539
Study Type
Interventional
Phase
Phase 3