(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 |
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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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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
AML |
| Interventions |
Drug: Quizartinib Drug: Salvage Chemotherapy |
| Enrollment | 367 |
Participant Flow
| Recruitment Details | A total of 367 participants who met the inclusion and none of the exclusion criteria were randomized (intent-to-treat population); 335 received study drug (safety analysis set). |
| Pre-assignment Details | Prior to randomization, the investigator was required to pre-select 1 of the 3 salvage chemotherapy regimens for each participant. Randomization was stratified by response to prior therapy (relapsed in ≤6 months [with or without HSCT] or refractory) and pre-selected salvage chemotherapy (high or low intensity chemotherapy) for all participants. |
| Arm/Group Title | Quizartinib | Salvage Chemotherapy |
|---|---|---|
 Arm/Group Description |
Participants who were randomized to receive 20 or 30 mg Quizartinib tablets administered orally once daily. | 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. |
| Period Title: Overall Study | ||
| Started | 245 | 122 |
| Ongoing (as of Data Cutoff) | 45 | 16 |
| Did Not Receive Treatment | 4 | 28 |
| Completed | 200 | 106 |
| Not Completed | 45 | 16 |
Baseline Characteristics
| Arm/Group Title | Quizartinib | Salvage Chemotherapy | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants who were randomized to receive 20 or 30 mg Quizartinib tablets administered orally once daily. | 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. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 245 | 122 | 367 | |
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Baseline Analysis Population Description |
Participants received standard of care salvage chemotherapy (administered subcutaneously [LoDac] or intravenously [MEC and FLAG-IDA]).
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 245 participants | 122 participants | 367 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
180 73.5%
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89 73.0%
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269 73.3%
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| >=65 years |
65 26.5%
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33 27.0%
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98 26.7%
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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| Number Analyzed | 245 participants | 122 participants | 367 participants | |
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55.0
(19 to 81)
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57.5
(18 to 78)
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56.0
(18 to 81)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 245 participants | 122 participants | 367 participants | |
| Female |
132 53.9%
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58 47.5%
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190 51.8%
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| Male |
113 46.1%
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64 52.5%
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177 48.2%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 245 participants | 122 participants | 367 participants | |
| American Indian or Alaska Native |
1 0.4%
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0 0.0%
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1 0.3%
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| Asian |
24 9.8%
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16 13.1%
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40 10.9%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
9 3.7%
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3 2.5%
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12 3.3%
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| White |
184 75.1%
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93 76.2%
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277 75.5%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
27 11.0%
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10 8.2%
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37 10.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 245 participants | 122 participants | 367 participants |
| Singapore | 0 | 2 | 2 | |
| Hong Kong | 5 | 3 | 8 | |
| Hungary | 1 | 0 | 1 | |
| United States | 82 | 36 | 118 | |
| Czechia | 2 | 0 | 2 | |
| United Kingdom | 21 | 14 | 35 | |
| Spain | 15 | 6 | 21 | |
| Canada | 18 | 5 | 23 | |
| Netherlands | 2 | 1 | 3 | |
| South Korea | 11 | 7 | 18 | |
| Belgium | 1 | 0 | 1 | |
| Taiwan | 2 | 1 | 3 | |
| Poland | 2 | 0 | 2 | |
| Italy | 34 | 19 | 53 | |
| Australia | 3 | 3 | 6 | |
| France | 20 | 7 | 27 | |
| Serbia | 1 | 0 | 1 | |
| Germany | 25 | 18 | 43 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Daiichi Sankyo |
| Organization: | Contact for Clinical Trial Information |
| Phone: | 1-908-992-6400 |
| EMail: | CTRinfo@dsi.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Daiichi Sankyo |
| ClinicalTrials.gov Identifier: | NCT02039726 |
| Other Study ID Numbers: |
AC220-007 EudraCT Number 2013-004890-28 ( Other Identifier: Universal Trial Number (UTN) U1111-1151-8078 ) |
| First Submitted: | January 15, 2014 |
| First Posted: | January 20, 2014 |
| Results First Submitted: | September 25, 2019 |
| Results First Posted: | January 27, 2020 |
| Last Update Posted: | February 24, 2021 |