(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive
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ClinicalTrials.gov Identifier: NCT02039726 |
Recruitment Status :
Completed
First Posted : January 20, 2014
Results First Posted : January 27, 2020
Last Update Posted : February 24, 2021
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Sponsor:
Daiichi Sankyo
Information provided by (Responsible Party):
Daiichi Sankyo
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Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | January 15, 2014 | ||||||||||||||||
First Posted Date ICMJE | January 20, 2014 | ||||||||||||||||
Results First Submitted Date ICMJE | September 25, 2019 | ||||||||||||||||
Results First Posted Date ICMJE | January 27, 2020 | ||||||||||||||||
Last Update Posted Date | February 24, 2021 | ||||||||||||||||
Actual Study Start Date ICMJE | May 2014 | ||||||||||||||||
Actual Primary Completion Date | February 22, 2018 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
Overall Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy [ Time Frame: At approximately 3 years 9 months ] Overall Survival is defined as the time (in weeks) from the date of randomization to the date of death due to any cause. Median and quartiles are calculated using the Kaplan-Meier method.
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Original Primary Outcome Measures ICMJE |
Overall Survival [ Time Frame: 1 year ] The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 (FLT3-ITD) positive Acute Myeloid Leukemia (AML) who are refractory to or have relapsed within 6 months, after first-line Acute Myeloid Leukemia (AML) therapy.
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Current Secondary Outcome Measures ICMJE |
Event-free Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy [ Time Frame: At approximately 3 years 9 months ] Event-free survival is defined as the time (in weeks) from randomization until documented refractory disease, relapse after complete composite remission (CRc), or death from any cause, whichever is observed first.
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Original Secondary Outcome Measures ICMJE |
Event-Free Survival [ Time Frame: 1 year ] The secondary objective is to determine event-free survival (EFS) with quizartinib versus salvage chemotherapy.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | (QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive | ||||||||||||||||
Official Title ICMJE | A Phase 3 Open-label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects With Tyrosine Kinase 3 - Internal Tandem Duplication (FLT3-ITD) Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation | ||||||||||||||||
Brief Summary | The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy. | ||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | AML | ||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||
Actual Enrollment ICMJE |
367 | ||||||||||||||||
Original Estimated Enrollment ICMJE |
326 | ||||||||||||||||
Actual Study Completion Date ICMJE | September 8, 2020 | ||||||||||||||||
Actual Primary Completion Date | February 22, 2018 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Listed Location Countries ICMJE | Australia, Belgium, Canada, Croatia, Czechia, France, Germany, Hong Kong, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Serbia, Singapore, Spain, Taiwan, United Kingdom, United States | ||||||||||||||||
Removed Location Countries | China, Czech Republic | ||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT02039726 | ||||||||||||||||
Other Study ID Numbers ICMJE | AC220-007 EudraCT Number 2013-004890-28 ( Other Identifier: Universal Trial Number (UTN) U1111-1151-8078 ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Daiichi Sankyo | ||||||||||||||||
Original Responsible Party | Ambit Biosciences Corporation | ||||||||||||||||
Current Study Sponsor ICMJE | Daiichi Sankyo | ||||||||||||||||
Original Study Sponsor ICMJE | Ambit Biosciences Corporation | ||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||
Investigators ICMJE |
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PRS Account | Daiichi Sankyo | ||||||||||||||||
Verification Date | February 2021 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |