Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Draft scope assessment: unclear. Attached because the study's own record names FLT3 and describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Maximum Tolerated Dose of Quizartinib (Phase I)

Source null

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primary · POSTED

(complete remission \[CR\]+complete response with incomplete bone marrow recovery \[CRI\]+partial remission \[PR\]+ hematologic improvement \[HI\]). Complete Rmission (CR) is bone marrow blasts of \</= 5%, platelets \>/= 100 and Absolute Neutrophil Count of \>/= 1000. complete response with incomplete bone marrow recovery \[CRI\] is is bone marrow blasts of \</= 5%, platelets \>/= 100 or Absolute Neutrophil Count of \>/= 1000. Hematologic improvement \[HI\]) is Bone Marrow Blasts \</= 5%. Partial remission \[PR\] is bone marrow blasts of \</= 5% with \> 50% reduction, platelets \>/= 100 and Absolute Neutrophil Count of \>/= 1000.

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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: NCT01892371
trial label: Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
applicability: unclear
applicability note: Attached because the study's own record names FLT3 and describes refractory disease. 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: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 2
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01892371
outcome key
om-0000
source section id
NCT01892371-om-0000
source outcome index
0
endpoint
Maximum Tolerated Dose of Quizartinib (Phase I)
endpoint definition
Maximum Tolerated Dose of Quizartinib (Phase I)
time origin
At 28 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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
NCT01892371
outcome key
om-0001
source section id
NCT01892371-om-0001
source outcome index
1
endpoint
Participants With a Response
endpoint definition
(complete remission \[CR\]+complete response with incomplete bone marrow recovery \[CRI\]+partial remission \[PR\]+ hematologic improvement \[HI\]). Complete Rmission (CR) is bone marrow blasts of \</= 5%, platelets \>/= 100 and Absolute Neutrophil Count of \>/= 1000. complete response with incomplete bone marrow recovery \[CRI\] is is bone marrow blasts of \</= 5%, platelets \>/= 100 or Absolute Neutrophil Count of \>/= 1000. Hematologic improvement \[HI\]) is Bone Marrow Blasts \</= 5%. Partial remission \[PR\] is bone marrow blasts of \</= 5% with \> 50% reduction, platelets \>/= 100 and Absolute Neutrophil Count of \>/= 1000.
time origin
At 56 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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
NCT01892371
outcome key
om-0000
arm key
OG000
arm label
Phase 1 Arm I (Quizartinib, Azacitidine)
regimen
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Quizartinib: Given PO
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01892371-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01892371
outcome key
om-0000
arm key
OG001
arm label
Phase 1 Arm II (Quizartinib, Cytarabine)
regimen
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cytarabine: Given SC Quizartinib: Given PO
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01892371-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01892371
outcome key
om-0001
arm key
OG000
arm label
Phase 1 Arm I (Quizartinib, Azacitidine)
regimen
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Quizartinib: Given PO
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01892371-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01892371
outcome key
om-0001
arm key
OG001
arm label
Phase 1 Arm II (Quizartinib, Cytarabine)
regimen
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cytarabine: Given SC Quizartinib: Given PO
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01892371-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01892371
outcome key
om-0001
arm key
OG002
arm label
Phase 2 Arm I (Quizartinib, Azacitidine)
regimen
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Quizartinib: Given PO
analyzed count
35
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01892371-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01892371
outcome key
om-0001
arm key
OG003
arm label
Phase 2 Arm II (Quizartinib, Cytarabine)
regimen
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cytarabine: Given SC
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01892371-om-0001#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01892371
harm key
EG000
source section id
NCT01892371-ae
event group key
EG000
event group label
Phase 1 Arm I (Quizartinib, Azacitidine)
serious affected
1
serious at risk
5
other affected
5
other at risk
5
frequency threshold
5
collection period
Up to 9 years, 2 months
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
NCT01892371
harm key
EG001
source section id
NCT01892371-ae
event group key
EG001
event group label
Phase 1 Arm II (Quizartinib, Cytarabine)
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
5
collection period
Up to 9 years, 2 months
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
NCT01892371
harm key
EG002
source section id
NCT01892371-ae
event group key
EG002
event group label
Phase 2 Arm I (Quizartinib, Azacitidine)
serious affected
14
serious at risk
35
other affected
32
other at risk
35
frequency threshold
5
collection period
Up to 9 years, 2 months
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
NCT01892371
harm key
EG003
source section id
NCT01892371-ae
event group key
EG003
event group label
Phase 2 Arm II (Quizartinib, Cytarabine)
serious affected
21
serious at risk
32
other affected
32
other at risk
32
frequency threshold
5
collection period
Up to 9 years, 2 months
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