Trial · NCT02668653
Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
NCT02668653, Phase 3, Completed, Daiichi Sankyo; results first posted 2022-10-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML). Trials, record NCT02668653. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02668653
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
- NCT number
- NCT02668653
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 539 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Acute Myeloid Leukemia, Leukemia
- Interventions
- Chemotherapy, Quizartinib, Placebo
- First posted
- 2016-01-29
- Last updated
- 2024-08-06
- Other registries' IDs
- eudract:2015-004856-24
- Results first posted
- 2022-10-05
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Date of randomization to the date of death due to any cause, up to approximately 3 years after enrollment | Overall survival is defined as the time from randomization until death from any cause. |
| Secondary | Event-free Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Date of randomization to the date of refractory disease, relapse, or death, up to approximately 3 years after enrollment | Event-free survival (EFS) is the time from randomization to the earliest date of either refractory disease (or treatment failure \[TF\]), relapse, or death from any cause. Refractory disease is defined as complete remission never achieved during Induction (CR: \>1000 neutrophils, \>100,000 platelets, \<5% blasts, and other \[defined as absence of extramedullary disease \[EMD\], blasts with rods, and leukemic blasts\]). For refractory disease, EFS event date is Day 1 (randomization). Relapse after CR is defined as ≥5% blasts, leukemic blasts, extramedullary leukemia, and presence of rods. This analysis is based on a response assessment with TF defined as not achieving response of CR, using a 42- day window from the start of the last cycle in Induction for CR evaluation. |
| Secondary | Complete Remission (CR) Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days) | Complete remission (CR) rate is defined as the percentage of participants achieving CR, defined as \<5% blasts, \>1000 neutrophils, \>100,000 platelets, and other \[defined as absence of extramedullary disease \[EMD\], blasts with rods, and leukemic blasts\], after induction |
| Secondary | Composite CR Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days) | Composite complete remission (CRc) rate is defined as the percentage of participants whose best response is complete remission (CR), defined as \<5% blasts, \>1000 neutrophils, \>100,000 platelets, and other \[defined as absence of extramedullary disease \[EMD\], blasts with rods, and leukemic blasts\], or CR with incomplete neutrophil or platelet recovery (CRi) at the end of first Induction cycle. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events Occurring in ≥10% Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Date of first dose up to 30 days after last dose, up to 36 cycles following continuation (approximately 6 years 11 months, each cycle is 28 days) | A treatment-emergent adverse event (TEAE) is defined as an adverse event that occur, having been absent before first dose of quizartinib or placebo, or have worsened in severity after initiating quizartinib or placebo. Adverse events collected more than 30 days after the last dose of quizartinib/placebo will not be considered TEAEs unless they are considered drug-related. |
| Secondary | Number of Participants Achieving CR With FLT3-ITD Minimal Residual Disease Negativity at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Approximately Cycle 1 Day 21 (Induction phase) to end of Induction phase, up to approximately 120 days (each Induction cycle is up to 60 days) | Complete remission (CR) is defined as participants achieving CR defined as \<5% blasts, \>1000 neutrophils, \>100,000 platelets, and other \[defined as absence of extramedullary disease \[EMD\], blasts with rods, and leukemic blasts\]. Minimal or measurable residual disease is the presence of a small number of leukemic cells in the bone marrow of patients with AML below the level of detection using conventional morphologic assessment. |
| Secondary | Number of Participants Achieving Composite CR With FLT3-ITD Minimal Residual Disease Negativity at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Approximately Cycle 1 Day 21 (Induction phase) to end of Induction phase, up to approximately 120 days (each Induction cycle is up to 60 days) | Composite complete remission (CRc) is defined as \<5% blasts, \>1000 neutrophils, \>100,000 platelets, and other \[defined as absence of extramedullary disease \[EMD\], blasts with rods, and leukemic blasts\], or CR with incomplete neutrophil or platelet recovery (CRi). Minimal or measurable residual disease is the presence of a small number of leukemic cells in the bone marrow of patients with AML below the level of detection using conventional morphologic assessment. |
| Secondary | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve at Steady State | Induction Cycle 1: Day 8, predose, 2-4 hours (hr) postdose on Days 8, 15, 21; Consolidation Cycle 1: Day 6, predose, 2-4 hr postdose on Days 6, 13, 19; Continuation Cycle 1: 2-4 hr postdose, Days 1, 8, 15; Cycle 2 Days 1 and 15 (each cycle, 28 days) | AUCss was assessed by population Pharmacokinetic (PK) analysis during Cycle 1 of each phase. |
| Secondary | Pharmacokinetic Parameter Steady State, Maximum Plasma Concentration (Css,Max) | Induction Cycle 1: Day 8, predose, 2-4 hours (hr) postdose on Days 8, 15, 21; Consolidation Cycle 1: Day 6, predose, 2-4 hr postdose on Days 6, 13, 19; Continuation Cycle 1: 2-4 hr postdose, Days 1, 8, 15; Cycle 2 Days 1 and 15 (each cycle, 28 days) | Css,max was assessed by population PK analysis during Cycle 1 of each phase. |
| Secondary | Pharmacokinetic Parameter Time to Maximum Plasma Concentration Steady State (Tmax,ss) | Induction Cycle 1: Day 8, predose, 2-4 hours (hr) postdose on Days 8, 15, 21; Consolidation Cycle 1: Day 6, predose, 2-4 hr postdose on Days 6, 13, 19; Continuation Cycle 1: 2-4 hr postdose, Days 1, 8, 15; Cycle 2 Days 1 and 15 (each cycle, 28 days) | Tmax,ss was assessed by population PK analysis during Cycle 1 of each phase. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Date of randomization to the date of death due to any cause, up to approximately 3 years after enrollment | Overall survival was assessed in the Intent-to-Treat Analysis Set. | months | MEDIAN |
| SECONDARY | Event-free Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Date of randomization to the date of refractory disease, relapse, or death, up to approximately 3 years after enrollment | Event-free survival was assessed in the Intent-to-Treat Analysis Set. | months | MEDIAN |
| SECONDARY | Complete Remission (CR) Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days) | Complete remission was assessed in the Intent-to-Treat Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Composite CR Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days) | Composite complete remission (CRc) rate was assessed in the Intent-to-Treat Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events Occurring in ≥10% Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Date of first dose up to 30 days after last dose, up to 36 cycles following continuation (approximately 6 years 11 months, each cycle is 28 days) | Treatment-emergent adverse events were assessed in the Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving CR With FLT3-ITD Minimal Residual Disease Negativity at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Approximately Cycle 1 Day 21 (Induction phase) to end of Induction phase, up to approximately 120 days (each Induction cycle is up to 60 days) | Complete remission was assessed in the Intent-to-Treat Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving Composite CR With FLT3-ITD Minimal Residual Disease Negativity at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Approximately Cycle 1 Day 21 (Induction phase) to end of Induction phase, up to approximately 120 days (each Induction cycle is up to 60 days) | Composite complete remission (CRc) rate was assessed in the Intent-to-Treat Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve at Steady State | Induction Cycle 1: Day 8, predose, 2-4 hours (hr) postdose on Days 8, 15, 21; Consolidation Cycle 1: Day 6, predose, 2-4 hr postdose on Days 6, 13, 19; Continuation Cycle 1: 2-4 hr postdose, Days 1, 8, 15; Cycle 2 Days 1 and 15 (each cycle, 28 days) | PK Parameters were assessed in the PK Analyses set, which includes all participants in the Intent-to-Treat Analysis Set who received at least 1 dose of quizartinib and had at least 1 PK sample assessed. | nanogram/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetic Parameter Steady State, Maximum Plasma Concentration (Css,Max) | Induction Cycle 1: Day 8, predose, 2-4 hours (hr) postdose on Days 8, 15, 21; Consolidation Cycle 1: Day 6, predose, 2-4 hr postdose on Days 6, 13, 19; Continuation Cycle 1: 2-4 hr postdose, Days 1, 8, 15; Cycle 2 Days 1 and 15 (each cycle, 28 days) | PK Parameters were assessed in the PK Analyses set, which includes all participants in the Intent-to-Treat Analysis Set who received at least 1 dose of quizartinib and had at least 1 PK sample assessed. | nanogram/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetic Parameter Time to Maximum Plasma Concentration Steady State (Tmax,ss) | Induction Cycle 1: Day 8, predose, 2-4 hours (hr) postdose on Days 8, 15, 21; Consolidation Cycle 1: Day 6, predose, 2-4 hr postdose on Days 6, 13, 19; Continuation Cycle 1: 2-4 hr postdose, Days 1, 8, 15; Cycle 2 Days 1 and 15 (each cycle, 28 days) | PK Parameters were assessed in the PK Analyses set, which includes all participants in the Intent-to-Treat Analysis Set who received at least 1 dose of quizartinib and had at least 1 PK sample assessed. | hours | MEDIAN |
Source ClinicalTrials.gov
Results by group122
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Quizartinib | 31.9 | 95% Confidence Interval 21.0 to NA | months | |
| Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Placebo | 15.1 | 95% Confidence Interval 13.2 to 26.2 | months | |
| Event-free Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Quizartinib | 0.03 | 95% Confidence Interval 0.03 to 0.95 | months | |
| Event-free Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Placebo | 0.71 | 95% Confidence Interval 0.03 to 3.42 | months | |
| Complete Remission (CR) Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Quizartinib | 147 | Participants | ||
| Complete Remission (CR) Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Placebo | 150 | Participants | ||
| Composite CR Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Quizartinib | 192 | Participants | ||
| Composite CR Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Placebo | 176 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events Occurring in ≥10% Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Quizartinib | Any TEAE | 264 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events Occurring in ≥10% Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Placebo | Any TEAE | 265 | Participants |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Quizartinib | 268 | |
| Overall Study | STARTED | Placebo | 271 | |
| Overall Study | Safety Analysis Set | Quizartinib | 265 | |
| Overall Study | Safety Analysis Set | Placebo | 268 | |
| Overall Study | COMPLETED | Quizartinib | 56 | |
| Overall Study | COMPLETED | Placebo | 52 | |
| Overall Study | NOT COMPLETED | Quizartinib | 212 | |
| Overall Study | NOT COMPLETED | Placebo | 219 |
Source ClinicalTrials.gov
Adverse events570
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Febrile neutropenia | Blood and lymphatic system disorders | Quizartinib | 98 | 265 | 169 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Placebo | 97 | 268 | 178 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Quizartinib | 31 | 265 | 46 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 25 | 268 | 37 |
| other | Anaemia | Blood and lymphatic system disorders | Quizartinib | 27 | 265 | 39 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 18 | 268 | 35 |
| other | Neutropenia | Blood and lymphatic system disorders | Quizartinib | 53 | 265 | 130 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 22 | 268 | 29 |
| other | Dry eye | Eye disorders | Quizartinib | 22 | 265 | 22 |
| other | Dry eye | Eye disorders | Placebo | 13 | 268 | 17 |
1 to 10 of 570Source ClinicalTrials.gov
See all 570 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Quizartinib | 130 | 265 |
| Total, all-cause mortality | Placebo | 156 | 268 |
| Total, other adverse events | Quizartinib | 258 | 265 |
| Total, other adverse events | Placebo | 258 | 268 |
| Total, serious adverse events | Quizartinib | 146 | 265 |
| Total, serious adverse events | Placebo | 124 | 268 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Quizartinib vs Placebo: Number of Participants Achieving CR With FLT3-ITD Minimal Residual Disease Negativity at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Trial comparisons |
| Quizartinib vs Placebo: Complete Remission (CR) Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Trial comparisons |
| Quizartinib vs Placebo: Composite CR Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Trial comparisons |
Quizartinib vs Placebo: Number of Participants Achieving Composite CR With FLT3-ITD Minimal Residual Disease Negativity at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia | Trial comparisons |
| Quizartinib vs Placebo: deaths from any cause | Trial comparisons |
| Quizartinib vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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