Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML

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

DLTs were classified according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Participants evaluable for determination of DLT: For each schedule and dose level tested, this population included all participants enrolled in the dose escalation part who received at least 70% of the study drug in the first cycle, unless the reason for non-compliance was drug-related toxicity, and for whom a DLT assessment was available within the DLT window. In case the participant did not fulfill 1 or more of the aforementioned criteria, he/she was to be replaced.

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primary · POSTED

CR = complete remission; CRc = composite complete remission rate; CRh = complete remission with partial hematologic recovery, CRi = complete remission with incomplete hematologic recovery; MLFS = morphologic leukemia free state; ORR = overall response rate; SD = stable disease Categories defined by the 2022 European LeukemiaNet (ELN) recommendations.

Patients Evaluable for Efficacy Analysis:This population included all enrolled participants in Phase 2 who were treated at RP2D \& had ≥1 hematologic assessment. Participants who had early death or withdrew before response assessment, or had technically suboptimal BM sample, were non-evaluable for response and excluded from efficacy dataset. For Cohort 1 and Cohort 2, only subset of subjects with FLT3-ITD mutation and no D835 mutation based on the central test were included in this population.

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secondary · POSTED

TEAE with maximum Common Terminology Criteria (CTC) grade (graded by NCI CTCAE Version 5.0) experienced by each participant is presented. If an AE was reported for a participant more than once during treatment, the worst CTC Grade is presented here. Phase 2 started before Phase 1 completed. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated.

Treated patient population: The treated patient population consists of all enrolled participants who actually receive at least one treatment administration. This population was evaluated in the analysis of patient disposition, baseline characteristics, treatment exposure, efficacy and safety.

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secondary · POSTED

Plasma samples were collected and used for pharmacokinetics assessments. Mean values of PK parameters are presented with the coefficient of variation (CV%)

Participants evaluable for PK analysis (treated participants were considered evaluable if they had sufficient baseline and on-study sampled material to provide interpretable results). The plasma PK of NMS-03592088 and 2 metabolites NMS-03593860 and NMS-03603422 were collected, and PK profile characterised. Schedule A: Day 1 and Day 21 Schedule B: Day 1 and Day 28

→

secondary · POSTED

Plasma samples were collected and used for pharmacokinetics (PK) assessments. Mean values of PK parameters are presented with the coefficient of variation (CV%)

Participants evaluable for PK analysis (participants with sufficient samples to provide interpretable results). The plasma PK of NMS-03592088 and NMS-03593860 and NMS-03603422 were collected for PK profile. Schedule B involved 28 days continuous treatment. Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.

→

secondary · POSTED

Plasma samples were collected and used for pharmacokinetics (PK) assessments. Mean values of PK parameters are presented with the coefficient of variation (CV%)

→

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-e73f312c
nct id: NCT03922100
trial label: Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML
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: 6
harms Count: 12
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-e73f312c
nct id
NCT03922100
outcome key
om-0000
source section id
NCT03922100-om-0000
source outcome index
0
endpoint
Phase I - Number of Participants With Drug Related First-cycle Dose Limiting Toxicities (DLTs)
endpoint definition
DLTs were classified according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
time origin
From screening to end of first 28-days cycle (47 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants evaluable for determination of DLT: For each schedule and dose level tested, this population included all participants enrolled in the dose escalation part who received at least 70% of the study drug in the first cycle, unless the reason for non-compliance was drug-related toxicity, and for whom a DLT assessment was available within the DLT window. In case the participant did not fulfill 1 or more of the aforementioned criteria, he/she was to be replaced.
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-e73f312c
nct id
NCT03922100
outcome key
om-0001
source section id
NCT03922100-om-0001
source outcome index
1
endpoint
Phase II - Number of Participants Who Achieved Composite Complete Remission (CRc) Rate i.e. Complete Remission (CR) + Complete Remission With Incomplete Hematologic Recovery (CRi).
endpoint definition
CR = complete remission; CRc = composite complete remission rate; CRh = complete remission with partial hematologic recovery, CRi = complete remission with incomplete hematologic recovery; MLFS = morphologic leukemia free state; ORR = overall response rate; SD = stable disease Categories defined by the 2022 European LeukemiaNet (ELN) recommendations.
time origin
At Screening; Day 1 of Cycle 2 and Cycle 3; and Day 1 at subsequent even cycle; up to End of Treatment visit (within 7 days of the final dose of study drug), up to 17 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients Evaluable for Efficacy Analysis:This population included all enrolled participants in Phase 2 who were treated at RP2D \& had ≥1 hematologic assessment. Participants who had early death or withdrew before response assessment, or had technically suboptimal BM sample, were non-evaluable for response and excluded from efficacy dataset. For Cohort 1 and Cohort 2, only subset of subjects with FLT3-ITD mutation and no D835 mutation based on the central test were included in this population.
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-e73f312c
nct id
NCT03922100
outcome key
om-0002
source section id
NCT03922100-om-0002
source outcome index
2
endpoint
Treatment-emergent Adverse Events (TEAEs) Graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 5.0 Criteria
endpoint definition
TEAE with maximum Common Terminology Criteria (CTC) grade (graded by NCI CTCAE Version 5.0) experienced by each participant is presented. If an AE was reported for a participant more than once during treatment, the worst CTC Grade is presented here. Phase 2 started before Phase 1 completed. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated.
time origin
Adverse events were collected from screening visit and assessed up to 18 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Treated patient population: The treated patient population consists of all enrolled participants who actually receive at least one treatment administration. This population was evaluated in the analysis of patient disposition, baseline characteristics, treatment exposure, efficacy and safety.
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-e73f312c
nct id
NCT03922100
outcome key
om-0003
source section id
NCT03922100-om-0003
source outcome index
3
endpoint
Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax), Last Measurable Concentration (Clast), and Average Concentration (Cavg) of NMS-03592088
endpoint definition
Plasma samples were collected and used for pharmacokinetics assessments. Mean values of PK parameters are presented with the coefficient of variation (CV%)
time origin
Schedule A: Day 1 and Day 21 Schedule B: Day 1 and Day 28
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants evaluable for PK analysis (treated participants were considered evaluable if they had sufficient baseline and on-study sampled material to provide interpretable results). The plasma PK of NMS-03592088 and 2 metabolites NMS-03593860 and NMS-03603422 were collected, and PK profile characterised. Schedule A: Day 1 and Day 21 Schedule B: Day 1 and Day 28
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-e73f312c
nct id
NCT03922100
outcome key
om-0004
source section id
NCT03922100-om-0004
source outcome index
4
endpoint
Pharmacokinetic Parameters: Time to Maximum Plasma Concentration (Tmax), Time to Last Measurable Concentration (Tlast), and Terminal Elimination Half-life (t½,z) of NMS-03592088
endpoint definition
Plasma samples were collected and used for pharmacokinetics (PK) assessments. Mean values of PK parameters are presented with the coefficient of variation (CV%)
time origin
Schedule A: Day 1 and 21 Schedule B: Day 1 and 28
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants evaluable for PK analysis (participants with sufficient samples to provide interpretable results). The plasma PK of NMS-03592088 and NMS-03593860 and NMS-03603422 were collected for PK profile. Schedule B involved 28 days continuous treatment. Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
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-e73f312c
nct id
NCT03922100
outcome key
om-0005
source section id
NCT03922100-om-0005
source outcome index
5
endpoint
Pharmacokinetic Parameter: Area Under the Concentration-time Curve to the Last Measurable Concentration (AUClast) and Area Under the Concentration-time Curve From Time Zero to 24 Hour (AUC0-24) of NMS-03592088
endpoint definition
Plasma samples were collected and used for pharmacokinetics (PK) assessments. Mean values of PK parameters are presented with the coefficient of variation (CV%)
time origin
Schedule A: Day 1 and Day 21 Schedule B: Day 1 and Day 28
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants evaluable for PK analysis (treated participants were considered evaluable if they had sufficient baseline and on-study sampled material to provide interpretable results). The plasma PK of NMS-03592088 and 2 metabolites NMS-03593860 and NMS-03603422 were collected, and PK profile characterised. Schedule A: Day 1 and Day 21 Schedule B: Day 1 and Day 28
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-e73f312c
nct id
NCT03922100
outcome key
om-0000
arm key
OG000
arm label
Phase 1, Schedule A: 20 mg
regimen
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 20 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03922100-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-e73f312c
nct id
NCT03922100
outcome key
om-0000
arm key
OG001
arm label
Phase 1, Schedule A: 40 mg
regimen
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 40 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03922100-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-e73f312c
nct id
NCT03922100
outcome key
om-0000
arm key
OG002
arm label
Phase 1, Schedule A: 80 mg
regimen
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 80 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03922100-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-e73f312c
nct id
NCT03922100
outcome key
om-0000
arm key
OG003
arm label
Phase 1, Schedule A: 120 mg
regimen
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03922100-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-e73f312c
nct id
NCT03922100
outcome key
om-0000
arm key
OG004
arm label
Phase 1, Schedule A: 180 mg
regimen
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03922100-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-e73f312c
nct id
NCT03922100
outcome key
om-0000
arm key
OG005
arm label
Phase 1, Schedule A: 270 mg
regimen
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 270 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03922100-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-e73f312c
nct id
NCT03922100
outcome key
om-0000
arm key
OG006
arm label
Phase 1, Schedule A: 300 mg
regimen
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 300 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03922100-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-e73f312c
nct id
NCT03922100
outcome key
om-0000
arm key
OG007
arm label
Phase 1, Schedule A: 360 mg
regimen
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 360 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03922100-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-e73f312c
nct id
NCT03922100
outcome key
om-0000
arm key
OG008
arm label
Phase 1, Schedule B: 120 mg
regimen
All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03922100-om-0000#groups/OG008
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-e73f312c
nct id
NCT03922100
outcome key
om-0000
arm key
OG009
arm label
Phase 1, Schedule B: 180 mg
regimen
All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 28 consecutive days, in a 28-day cycle.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03922100-om-0000#groups/OG009
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-e73f312c
nct id
NCT03922100
outcome key
om-0000
arm key
OG010
arm label
Phase 1, Schedule B: 250 mg
regimen
All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 250 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03922100-om-0000#groups/OG010
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-e73f312c
nct id
NCT03922100
outcome key
om-0001
arm key
OG000
arm label
Phase 2, Schedule B, Cohort 1:360+150 mg
regimen
Participants who had failed standard of care including Venetoclax and Gilteritining based therapies. NMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03922100-om-0001#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-e73f312c
nct id
NCT03922100
harm key
EG000
source section id
NCT03922100-ae
event group key
EG000
event group label
Phase 1, Schedule A: 20 mg
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Adverse events were collected from screening visit and assessed up to 18 months
event definition
Adverse events (AEs) were assessed and documented at each scheduled clinic visit from signing Informed Consent until 42 days after last on-study treatment administration, or until all serious or study drug-related toxicities had resolved or determined to be "chronic" or "stable," whichever came first, or until alternative anticancer therapy was initiated. Reporting period ended at the time new treatment started.
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-e73f312c
nct id
NCT03922100
harm key
EG001
source section id
NCT03922100-ae
event group key
EG001
event group label
Phase 1, Schedule A: 40 mg
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Adverse events were collected from screening visit and assessed up to 18 months
event definition
Adverse events (AEs) were assessed and documented at each scheduled clinic visit from signing Informed Consent until 42 days after last on-study treatment administration, or until all serious or study drug-related toxicities had resolved or determined to be "chronic" or "stable," whichever came first, or until alternative anticancer therapy was initiated. Reporting period ended at the time new treatment started.
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-e73f312c
nct id
NCT03922100
harm key
EG002
source section id
NCT03922100-ae
event group key
EG002
event group label
Phase 1, Schedule A: 80 mg
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Adverse events were collected from screening visit and assessed up to 18 months
event definition
Adverse events (AEs) were assessed and documented at each scheduled clinic visit from signing Informed Consent until 42 days after last on-study treatment administration, or until all serious or study drug-related toxicities had resolved or determined to be "chronic" or "stable," whichever came first, or until alternative anticancer therapy was initiated. Reporting period ended at the time new treatment started.
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-e73f312c
nct id
NCT03922100
harm key
EG003
source section id
NCT03922100-ae
event group key
EG003
event group label
Phase 1, Schedule A: 120 mg
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Adverse events were collected from screening visit and assessed up to 18 months
event definition
Adverse events (AEs) were assessed and documented at each scheduled clinic visit from signing Informed Consent until 42 days after last on-study treatment administration, or until all serious or study drug-related toxicities had resolved or determined to be "chronic" or "stable," whichever came first, or until alternative anticancer therapy was initiated. Reporting period ended at the time new treatment started.
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-e73f312c
nct id
NCT03922100
harm key
EG004
source section id
NCT03922100-ae
event group key
EG004
event group label
Phase 1, Schedule A: 180 mg
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Adverse events were collected from screening visit and assessed up to 18 months
event definition
Adverse events (AEs) were assessed and documented at each scheduled clinic visit from signing Informed Consent until 42 days after last on-study treatment administration, or until all serious or study drug-related toxicities had resolved or determined to be "chronic" or "stable," whichever came first, or until alternative anticancer therapy was initiated. Reporting period ended at the time new treatment started.
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-e73f312c
nct id
NCT03922100
harm key
EG005
source section id
NCT03922100-ae
event group key
EG005
event group label
Phase 1, Schedule A: 270 mg
serious affected
3
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
Adverse events were collected from screening visit and assessed up to 18 months
event definition
Adverse events (AEs) were assessed and documented at each scheduled clinic visit from signing Informed Consent until 42 days after last on-study treatment administration, or until all serious or study drug-related toxicities had resolved or determined to be "chronic" or "stable," whichever came first, or until alternative anticancer therapy was initiated. Reporting period ended at the time new treatment started.
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-e73f312c
nct id
NCT03922100
harm key
EG006
source section id
NCT03922100-ae
event group key
EG006
event group label
Phase 1, Schedule A: 300 mg
serious affected
8
serious at risk
10
other affected
10
other at risk
10
frequency threshold
0
collection period
Adverse events were collected from screening visit and assessed up to 18 months
event definition
Adverse events (AEs) were assessed and documented at each scheduled clinic visit from signing Informed Consent until 42 days after last on-study treatment administration, or until all serious or study drug-related toxicities had resolved or determined to be "chronic" or "stable," whichever came first, or until alternative anticancer therapy was initiated. Reporting period ended at the time new treatment started.
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-e73f312c
nct id
NCT03922100
harm key
EG007
source section id
NCT03922100-ae
event group key
EG007
event group label
Phase 1, Schedule A: 360 mg
serious affected
3
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Adverse events were collected from screening visit and assessed up to 18 months
event definition
Adverse events (AEs) were assessed and documented at each scheduled clinic visit from signing Informed Consent until 42 days after last on-study treatment administration, or until all serious or study drug-related toxicities had resolved or determined to be "chronic" or "stable," whichever came first, or until alternative anticancer therapy was initiated. Reporting period ended at the time new treatment started.
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-e73f312c
nct id
NCT03922100
harm key
EG008
source section id
NCT03922100-ae
event group key
EG008
event group label
Phase 1, Schedule B: 120 mg
serious affected
4
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
Adverse events were collected from screening visit and assessed up to 18 months
event definition
Adverse events (AEs) were assessed and documented at each scheduled clinic visit from signing Informed Consent until 42 days after last on-study treatment administration, or until all serious or study drug-related toxicities had resolved or determined to be "chronic" or "stable," whichever came first, or until alternative anticancer therapy was initiated. Reporting period ended at the time new treatment started.
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-e73f312c
nct id
NCT03922100
harm key
EG009
source section id
NCT03922100-ae
event group key
EG009
event group label
Phase 1, Schedule B: 180 mg
serious affected
6
serious at risk
6
other affected
6
other at risk
6
frequency threshold
0
collection period
Adverse events were collected from screening visit and assessed up to 18 months
event definition
Adverse events (AEs) were assessed and documented at each scheduled clinic visit from signing Informed Consent until 42 days after last on-study treatment administration, or until all serious or study drug-related toxicities had resolved or determined to be "chronic" or "stable," whichever came first, or until alternative anticancer therapy was initiated. Reporting period ended at the time new treatment started.
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-e73f312c
nct id
NCT03922100
harm key
EG010
source section id
NCT03922100-ae
event group key
EG010
event group label
Phase 1, Schedule B: 250 mg
serious affected
4
serious at risk
4
other affected
3
other at risk
4
frequency threshold
0
collection period
Adverse events were collected from screening visit and assessed up to 18 months
event definition
Adverse events (AEs) were assessed and documented at each scheduled clinic visit from signing Informed Consent until 42 days after last on-study treatment administration, or until all serious or study drug-related toxicities had resolved or determined to be "chronic" or "stable," whichever came first, or until alternative anticancer therapy was initiated. Reporting period ended at the time new treatment started.
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-e73f312c
nct id
NCT03922100
harm key
EG011
source section id
NCT03922100-ae
event group key
EG011
event group label
Phase 2, Schedule B: 360-150 mg
serious affected
14
serious at risk
15
other affected
14
other at risk
15
frequency threshold
0
collection period
Adverse events were collected from screening visit and assessed up to 18 months
event definition
Adverse events (AEs) were assessed and documented at each scheduled clinic visit from signing Informed Consent until 42 days after last on-study treatment administration, or until all serious or study drug-related toxicities had resolved or determined to be "chronic" or "stable," whichever came first, or until alternative anticancer therapy was initiated. Reporting period ended at the time new treatment started.
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

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Preserved source evidence · Not medical advice