TriangleNCT02668653 · STUDY IN CONTEXT
Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
Draft scope assessment: unclear. Attached because the study's own record names FLT3. The study record does not state mutation, so it may describe a different alteration of the same gene. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Overall survival is defined as the time from randomization until death from any cause.
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.
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
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- trial label
- Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
- applicability
- unclear
- applicability note
- Attached because the study's own record names FLT3. The study record does not state mutation, so it may describe a different alteration of the same gene. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0000
- source section id
- NCT02668653-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
- endpoint definition
- Overall survival is defined as the time from randomization until death from any cause.
- time origin
- Date of randomization to the date of death due to any cause, up to approximately 3 years after enrollment
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Overall survival was assessed in the Intent-to-Treat Analysis Set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0001
- source section id
- NCT02668653-om-0001
- source outcome index
- 1
- endpoint
- Event-free Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
- endpoint definition
- 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.
- time origin
- Date of randomization to the date of refractory disease, relapse, or death, up to approximately 3 years after enrollment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Event-free survival was assessed in the Intent-to-Treat Analysis Set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0002
- source section id
- NCT02668653-om-0002
- source outcome index
- 2
- endpoint
- Complete Remission (CR) Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
- endpoint definition
- 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
- time origin
- Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Complete remission was assessed in the Intent-to-Treat Analysis Set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0003
- source section id
- NCT02668653-om-0003
- source outcome index
- 3
- endpoint
- Composite CR Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
- endpoint definition
- 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.
- time origin
- Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Composite complete remission (CRc) rate was assessed in the Intent-to-Treat Analysis Set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0004
- source section id
- NCT02668653-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Treatment-emergent Adverse Events Occurring in ≥10% Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
- endpoint definition
- 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.
- time origin
- 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)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Treatment-emergent adverse events were assessed in the Safety Analysis Set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0005
- source section id
- NCT02668653-om-0005
- source outcome index
- 5
- endpoint
- 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
- endpoint definition
- 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.
- time origin
- 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)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Complete remission was assessed in the Intent-to-Treat Analysis Set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Quizartinib
- regimen
- Participants who were randomized to receive quizartinib treatment regimen.
- analyzed count
- 268
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02668653-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants who were randomized to receive placebo treatment regimen.
- analyzed count
- 271
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02668653-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Quizartinib
- regimen
- Participants who were randomized to receive quizartinib treatment regimen.
- analyzed count
- 268
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02668653-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants who were randomized to receive placebo treatment regimen.
- analyzed count
- 271
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02668653-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Quizartinib
- regimen
- Participants who were randomized to receive quizartinib treatment regimen.
- analyzed count
- 268
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02668653-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants who were randomized to receive placebo treatment regimen.
- analyzed count
- 271
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02668653-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Quizartinib
- regimen
- Participants who were randomized to receive quizartinib treatment regimen.
- analyzed count
- 268
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02668653-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants who were randomized to receive placebo treatment regimen.
- analyzed count
- 271
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02668653-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Quizartinib
- regimen
- Participants who were randomized to receive quizartinib treatment regimen.
- analyzed count
- 265
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02668653-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants who were randomized to receive placebo treatment regimen.
- analyzed count
- 268
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02668653-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Quizartinib
- regimen
- Participants who were randomized to receive quizartinib treatment regimen.
- analyzed count
- 268
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02668653-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants who were randomized to receive placebo treatment regimen.
- analyzed count
- 271
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02668653-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- harm key
- EG000
- source section id
- NCT02668653-ae
- event group key
- EG000
- event group label
- Quizartinib
- serious affected
- 146
- serious at risk
- 265
- other affected
- 258
- other at risk
- 265
- frequency threshold
- 5
- collection period
- Treatment-emergent adverse events were collected from date of first dose up to 30 days after last dose, up to 36 cycles following continuation phase (approximately 6 years 11 months, each cycle is 28 days).
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-xospata-bab9e68c
- nct id
- NCT02668653
- harm key
- EG001
- source section id
- NCT02668653-ae
- event group key
- EG001
- event group label
- Placebo
- serious affected
- 124
- serious at risk
- 268
- other affected
- 258
- other at risk
- 268
- frequency threshold
- 5
- collection period
- Treatment-emergent adverse events were collected from date of first dose up to 30 days after last dose, up to 36 cycles following continuation phase (approximately 6 years 11 months, each cycle is 28 days).
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice