(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 : Active, not recruiting
First Posted : January 20, 2014
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|AML||Drug: Quizartinib Drug: Salvage Chemotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||367 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||May 2014|
|Actual Primary Completion Date :||February 22, 2018|
|Estimated Study Completion Date :||December 2020|
Participants who were randomized to receive 20 or 30 mg quizartinib tablets administered orally once daily.
20 or 30 mg quizartinib tablets administered orally once daily
Other Name: AC220
Active Comparator: Salvage chemotherapy
Participants who were randomized to receive salvage chemotherapy, such as low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA), were administered during 28-day cycles.
Drug: Salvage Chemotherapy
Low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA) administered during 28-day cycles
Other Name: Standard of Care
- Overall Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy [ Time Frame: At data cut off 22 February 2018 (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.
- Event-free Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy [ Time Frame: At data cut off 22 February 2018 (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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039726
|Principal Investigator:||Jorge E. Cortes, MD||M.D. Anderson Cancer Center|
|Study Director:||Global Clinical Leader||Daiichi Sankyo, Inc.|