Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. 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

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

primary · POSTED

CCR rate was defined as percentage of participants with complete remission/response (CR) and clinical complete remission (CRc). CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/microliter \[μL\]) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on computed tomography (CT); and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.

Modified Intent-to-treat (mITT) Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = Frontline de novo BPDCN participants. Per protocol, this endpoint evaluated only Frontline De Novo BPDCN Participants, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.

→

secondary · POSTED

An adverse event (AE) was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included an exacerbation of a pre-existing condition. SAEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any new AEs that begin or any pre-existing conditions that worsen in severity from the first dose of study drug through 30 days after the last dose or prior to the subsequent therapy, whichever occurs first.

The safety population included all participants who received at least 1 dose of study drug.

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secondary · POSTED

DLT was defined as all treatment-emergent adverse events (TEAEs) or abnormal laboratory values that met the protocol-defined DLT criteria, including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

The safety population included all participants who received at least 1 dose of study drug.

→

secondary · POSTED

Maximum Plasma Concentration (Cmax) of IMGN632 (Antibody Drug Conjugate [ADC]) and Total Antibody

Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study drug and from whom results of concentration had been obtained at least 1 sampling point. PK data were collected and analyses were conducted in participants per treatment schedule and dose in both phases (dose escalation and expansion) combined. Here, 'number analyzed' = participants evaluable for specified categories.

→

secondary · POSTED

Cmax of FGN849

PK analysis set included all participants who received at least 1 dose of study drug and from whom results of concentration had been obtained at least 1 sampling point. PK data were collected and analyses were conducted in participants per treatment schedule and dose in both phases (dose escalation and expansion) combined. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

→

secondary · POSTED

Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of IMGN632 (ADC) and Total Antibody

The PK analysis set included all participants who received at least 1 dose of study drug and from whom results of concentration had been obtained at least 1 sampling point. PK data were collected and analyses were conducted in participants per treatment schedule and dose in both phases (dose escalation and expansion) combined. Here, 'number analyzed' = participants evaluable for specified categories.

→

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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id: NCT03386513
trial label: Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
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: 11
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0000
source section id
NCT03386513-om-0000
source outcome index
0
endpoint
Composite Complete Remission/Response (CCR) Rate As Assessed by Investigator in Frontline De Novo Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Participants
endpoint definition
CCR rate was defined as percentage of participants with complete remission/response (CR) and clinical complete remission (CRc). CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/microliter \[μL\]) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on computed tomography (CT); and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
time origin
Up to approximately 81 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Modified Intent-to-treat (mITT) Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = Frontline de novo BPDCN participants. Per protocol, this endpoint evaluated only Frontline De Novo BPDCN Participants, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.
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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0001
source section id
NCT03386513-om-0001
source outcome index
1
endpoint
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
endpoint definition
An adverse event (AE) was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included an exacerbation of a pre-existing condition. SAEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any new AEs that begin or any pre-existing conditions that worsen in severity from the first dose of study drug through 30 days after the last dose or prior to the subsequent therapy, whichever occurs first.
time origin
Up to approximately 81 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The safety population included all participants who received at least 1 dose of study drug.
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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0002
source section id
NCT03386513-om-0002
source outcome index
2
endpoint
Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs)
endpoint definition
DLT was defined as all treatment-emergent adverse events (TEAEs) or abnormal laboratory values that met the protocol-defined DLT criteria, including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
time origin
Up to approximately 81 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The safety population included all participants who received at least 1 dose of study drug.
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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0003
source section id
NCT03386513-om-0003
source outcome index
3
endpoint
Maximum Plasma Concentration (Cmax) of IMGN632 (Antibody Drug Conjugate [ADC]) and Total Antibody
endpoint definition
Maximum Plasma Concentration (Cmax) of IMGN632 (Antibody Drug Conjugate [ADC]) and Total Antibody
time origin
Cycle 1 and Cycle 3 (each cycle length = 21 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study drug and from whom results of concentration had been obtained at least 1 sampling point. PK data were collected and analyses were conducted in participants per treatment schedule and dose in both phases (dose escalation and expansion) combined. Here, 'number analyzed' = participants evaluable for specified categories.
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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0004
source section id
NCT03386513-om-0004
source outcome index
4
endpoint
Cmax of FGN849
endpoint definition
Cmax of FGN849
time origin
Cycle 1 and Cycle 3 (each cycle length = 21 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
PK analysis set included all participants who received at least 1 dose of study drug and from whom results of concentration had been obtained at least 1 sampling point. PK data were collected and analyses were conducted in participants per treatment schedule and dose in both phases (dose escalation and expansion) combined. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0005
source section id
NCT03386513-om-0005
source outcome index
5
endpoint
Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of IMGN632 (ADC) and Total Antibody
endpoint definition
Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of IMGN632 (ADC) and Total Antibody
time origin
Cycle 1 and Cycle 3 (each cycle length = 21 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The PK analysis set included all participants who received at least 1 dose of study drug and from whom results of concentration had been obtained at least 1 sampling point. PK data were collected and analyses were conducted in participants per treatment schedule and dose in both phases (dose escalation and expansion) combined. Here, 'number analyzed' = participants evaluable for specified categories.
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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0000
arm key
OG000
arm label
Frontline De Novo BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg
regimen
Participants received IMGN632 via IV infusion on Day 1 of each 21-day cycle.
analyzed count
22
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03386513-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0001
arm key
OG000
arm label
Dose Escalation - Schedule A: IMGN632 0.015 mg/kg
regimen
Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03386513-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0001
arm key
OG001
arm label
Dose Escalation - Schedule A: IMGN632 0.045 mg/kg
regimen
Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03386513-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0001
arm key
OG002
arm label
Dose Escalation - Schedule A: IMGN632 0.09 mg/kg
regimen
Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03386513-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0001
arm key
OG003
arm label
Dose Escalation - Schedule A: IMGN632 0.18 mg/kg
regimen
Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03386513-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0001
arm key
OG004
arm label
Dose Escalation - Schedule A: IMGN632 0.3 mg/kg
regimen
Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03386513-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0001
arm key
OG005
arm label
Dose Escalation - Schedule A: IMGN632 0.45 mg/kg
regimen
Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03386513-om-0001#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0001
arm key
OG006
arm label
Dose Escalation - Schedule B: IMGN632 0.015 mg/kg
regimen
Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03386513-om-0001#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0001
arm key
OG007
arm label
Dose Escalation - Schedule B: IMGN632 0.03 mg/kg
regimen
Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03386513-om-0001#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0001
arm key
OG008
arm label
Dose Escalation - Schedule B: IMGN632 0.06 mg/kg
regimen
Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03386513-om-0001#groups/OG008
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0002
arm key
OG000
arm label
Dose Escalation - Schedule A: IMGN632 0.015 mg/kg
regimen
Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03386513-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
outcome key
om-0002
arm key
OG001
arm label
Dose Escalation - Schedule A: IMGN632 0.045 mg/kg
regimen
Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03386513-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
harm key
EG000
source section id
NCT03386513-ae
event group key
EG000
event group label
Dose Escalation - Schedule A: IMGN632 0.015 mg/kg
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Up to approximately 81 months
event definition
The safety population included all participants who received at least 1 dose of study drug.
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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
harm key
EG001
source section id
NCT03386513-ae
event group key
EG001
event group label
Dose Escalation - Schedule A: IMGN632 0.045 mg/kg
serious affected
8
serious at risk
12
other affected
12
other at risk
12
frequency threshold
5
collection period
Up to approximately 81 months
event definition
The safety population included all participants who received at least 1 dose of study drug.
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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
harm key
EG002
source section id
NCT03386513-ae
event group key
EG002
event group label
Dose Escalation - Schedule A: IMGN632 0.09 mg/kg
serious affected
11
serious at risk
13
other affected
13
other at risk
13
frequency threshold
5
collection period
Up to approximately 81 months
event definition
The safety population included all participants who received at least 1 dose of study drug.
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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
harm key
EG003
source section id
NCT03386513-ae
event group key
EG003
event group label
Dose Escalation - Schedule A: IMGN632 0.18 mg/kg
serious affected
7
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
Up to approximately 81 months
event definition
The safety population included all participants who received at least 1 dose of study drug.
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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
harm key
EG004
source section id
NCT03386513-ae
event group key
EG004
event group label
Dose Escalation - Schedule A: IMGN632 0.3 mg/kg
serious affected
5
serious at risk
5
other affected
5
other at risk
5
frequency threshold
5
collection period
Up to approximately 81 months
event definition
The safety population included all participants who received at least 1 dose of study drug.
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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
harm key
EG005
source section id
NCT03386513-ae
event group key
EG005
event group label
Dose Escalation - Schedule A: IMGN632 0.45 mg/kg
serious affected
2
serious at risk
2
other affected
2
other at risk
2
frequency threshold
5
collection period
Up to approximately 81 months
event definition
The safety population included all participants who received at least 1 dose of study drug.
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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
harm key
EG006
source section id
NCT03386513-ae
event group key
EG006
event group label
Dose Escalation - Schedule B: IMGN632 0.015 mg/kg
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Up to approximately 81 months
event definition
The safety population included all participants who received at least 1 dose of study drug.
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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
harm key
EG007
source section id
NCT03386513-ae
event group key
EG007
event group label
Dose Escalation - Schedule B: IMGN632 0.03 mg/kg
serious affected
6
serious at risk
6
other affected
5
other at risk
6
frequency threshold
5
collection period
Up to approximately 81 months
event definition
The safety population included all participants who received at least 1 dose of study drug.
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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
harm key
EG008
source section id
NCT03386513-ae
event group key
EG008
event group label
Dose Escalation - Schedule B: IMGN632 0.06 mg/kg
serious affected
12
serious at risk
14
other affected
12
other at risk
14
frequency threshold
5
collection period
Up to approximately 81 months
event definition
The safety population included all participants who received at least 1 dose of study drug.
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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
harm key
EG009
source section id
NCT03386513-ae
event group key
EG009
event group label
Dose Expansion - Schedule A: IMGN632 0.045 mg/kg
serious affected
66
serious at risk
104
other affected
102
other at risk
104
frequency threshold
5
collection period
Up to approximately 81 months
event definition
The safety population included all participants who received at least 1 dose of study drug.
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-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT03386513
harm key
EG010
source section id
NCT03386513-ae
event group key
EG010
event group label
Dose Expansion - Schedule A: IMGN632 0.09 mg/kg
serious affected
10
serious at risk
10
other affected
10
other at risk
10
frequency threshold
5
collection period
Up to approximately 81 months
event definition
The safety population included all participants who received at least 1 dose of study drug.
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