Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia

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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Maximum tolerated dose (MTD) in both patients with BPDCN and AML. MTD defined as the highest dose level where less than 2/3 or 2/6 patients experienced a DLT

Patients with First-line Blastic Plasmacytoid Dendritic Cell Neoplasm, R/R Blastic Plasmacytoid Dendritic Cell Neoplasm and Acute Myeloid Leukemia participating to stage 1 (dose-escalation)

→

primary · POSTED

Complete response (CR) rate, defined as the percentage who achieved CR+ CR(clinical) with minimal residual skin abnormality (CRc) after treatment with Tagraxofusp. CR criteria according to Cheson BD et al, The International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-586: Marrow: normalization of blast percentage (≤5%). Peripheral blood: normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL) - absence of leukemic blasts Skin: 100% clearance of all skin lesions from baseline; no new lesions in patients without lesions at baseline Nodal masses: regression to normal size on CT Spleen, liver: not palpable, nodules disappeared CRc criteria: all the above except for skin: marked clearance of all skin lesions from baseline; residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed)

Pre-defined efficacy primary end point assessed in Stage 3, standalone, pivotal efficacy cohort of only patients with first-line BPDCN exposed to 12 μg/kg/day were enrolled.

→

secondary · POSTED

CR rate, defined as the percentage of patients who achieved CR+ CR with minimal residual skin abnormality (CRc) after treatment with Tagraxofusp. CR criteria according to Cheson BD et al, The International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-586: Marrow: normalization of blast percentage (≤5%) Peripheral blood: normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL) - absence of leukemic blasts Skin: 100% clearance of all skin lesions from baseline; no new lesions in patients without lesions at baseline Nodal masses: regression to normal size on CT Spleen, liver: not palpable, nodules disappeared CRc criteria: all the above except for skin: marked clearance of all skin lesions from baseline; residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed)

Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML.

→

secondary · POSTED

Duration of complete response (CR) defined as the time from when the criteria are first met for CR+CRc (whichever was recorded first) until the date that the criteria for relapse after CR+CRc are met, according to the previously reported criteria for CR and CRc and following criteria of relapse after CR+CRc (Cheson BD et al. J Clin Oncol 2007;25:579-586.): Marrow: blast percentage \>5% (if no peripheral blasts, then confirmation aspirate required ≥ 1week later) Peripheral blood: presence of leukemic blasts Skin: increase in skin score greater than the sum of nadir plus 50% baseline score Nodal masses: appearance of a new lesion(s) \>1.5 cm in any axis, ≥50% increase from nadir in SPD of more than one node, or ≥50% increase from nadir in longest diameter of a previously identified node \>1cm in short axis Spleen, liver: \>50% increase from nadir in the SPD of any previous lesions

Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML

→

secondary · POSTED

Objective response rate (ORR) defines as the percentage of patients who achieved CR (CR+CRc), CR with incomplete blood count recovery (CRi), or partial response (PR) after treatment with Tagraxofusp according to the previously reported definitions of CR, CRc and the following one of CRi and PR: CRi: CR with incomplete of neutrophil and/or platelet count and absence of leukemic blast in the peripheral blood Marrow: PR defined as decrease by ≥50% in blast percentage to 5-25% Peripheral blood: PR defined as normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL) Skin: 50%-\<100% clearance of all skis lesions from baseline; no new lesions in patients without lesions at baseline Nodal masses: ≥50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes Spleen, liver: ≥50% in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen

Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML

→

secondary · POSTED

Overall survival (months) defined as the time from the date of first infusion of Tagraxofusp to the date of death from any cause

Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML

→

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: NCT02113982
trial label: Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia
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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 14
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT02113982
outcome key
om-0000
source section id
NCT02113982-om-0000
source outcome index
0
endpoint
MTD (Stage 1)
endpoint definition
Maximum tolerated dose (MTD) in both patients with BPDCN and AML. MTD defined as the highest dose level where less than 2/3 or 2/6 patients experienced a DLT
time origin
21-day period after the first dose (cycle 1)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients with First-line Blastic Plasmacytoid Dendritic Cell Neoplasm, R/R Blastic Plasmacytoid Dendritic Cell Neoplasm and Acute Myeloid Leukemia participating to stage 1 (dose-escalation)
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
NCT02113982
outcome key
om-0001
source section id
NCT02113982-om-0001
source outcome index
1
endpoint
CR Rate in First-line BPDCN (Stage 3, Pivotal Cohort)
endpoint definition
Complete response (CR) rate, defined as the percentage who achieved CR+ CR(clinical) with minimal residual skin abnormality (CRc) after treatment with Tagraxofusp. CR criteria according to Cheson BD et al, The International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-586: Marrow: normalization of blast percentage (≤5%). Peripheral blood: normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL) - absence of leukemic blasts Skin: 100% clearance of all skin lesions from baseline; no new lesions in patients without lesions at baseline Nodal masses: regression to normal size on CT Spleen, liver: not palpable, nodules disappeared CRc criteria: all the above except for skin: marked clearance of all skin lesions from baseline; residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed)
time origin
at pre-defined treatment cycle intervals from randomization up to disease progression, up to 3.5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Pre-defined efficacy primary end point assessed in Stage 3, standalone, pivotal efficacy cohort of only patients with first-line BPDCN exposed to 12 μg/kg/day were enrolled.
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
NCT02113982
outcome key
om-0002
source section id
NCT02113982-om-0002
source outcome index
2
endpoint
CR Rate in First-line BPDCN, R/R BPDCN and AML
endpoint definition
CR rate, defined as the percentage of patients who achieved CR+ CR with minimal residual skin abnormality (CRc) after treatment with Tagraxofusp. CR criteria according to Cheson BD et al, The International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-586: Marrow: normalization of blast percentage (≤5%) Peripheral blood: normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL) - absence of leukemic blasts Skin: 100% clearance of all skin lesions from baseline; no new lesions in patients without lesions at baseline Nodal masses: regression to normal size on CT Spleen, liver: not palpable, nodules disappeared CRc criteria: all the above except for skin: marked clearance of all skin lesions from baseline; residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed)
time origin
at pre-defined treatment cycle intervals from randomization up to disease progression, up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML.
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
NCT02113982
outcome key
om-0003
source section id
NCT02113982-om-0003
source outcome index
3
endpoint
Duration of CR in First-line BPDCN, R/R BPDCN and AML
endpoint definition
Duration of complete response (CR) defined as the time from when the criteria are first met for CR+CRc (whichever was recorded first) until the date that the criteria for relapse after CR+CRc are met, according to the previously reported criteria for CR and CRc and following criteria of relapse after CR+CRc (Cheson BD et al. J Clin Oncol 2007;25:579-586.): Marrow: blast percentage \>5% (if no peripheral blasts, then confirmation aspirate required ≥ 1week later) Peripheral blood: presence of leukemic blasts Skin: increase in skin score greater than the sum of nadir plus 50% baseline score Nodal masses: appearance of a new lesion(s) \>1.5 cm in any axis, ≥50% increase from nadir in SPD of more than one node, or ≥50% increase from nadir in longest diameter of a previously identified node \>1cm in short axis Spleen, liver: \>50% increase from nadir in the SPD of any previous lesions
time origin
at pre-defined treatment cycle intervals from randomization up to disease progression, up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML
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
NCT02113982
outcome key
om-0004
source section id
NCT02113982-om-0004
source outcome index
4
endpoint
ORR in First-line BPDCN, R/R BPDCN and AML
endpoint definition
Objective response rate (ORR) defines as the percentage of patients who achieved CR (CR+CRc), CR with incomplete blood count recovery (CRi), or partial response (PR) after treatment with Tagraxofusp according to the previously reported definitions of CR, CRc and the following one of CRi and PR: CRi: CR with incomplete of neutrophil and/or platelet count and absence of leukemic blast in the peripheral blood Marrow: PR defined as decrease by ≥50% in blast percentage to 5-25% Peripheral blood: PR defined as normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL) Skin: 50%-\<100% clearance of all skis lesions from baseline; no new lesions in patients without lesions at baseline Nodal masses: ≥50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes Spleen, liver: ≥50% in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen
time origin
at pre-defined treatment cycle intervals from randomization up to disease progression, up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML
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
NCT02113982
outcome key
om-0005
source section id
NCT02113982-om-0005
source outcome index
5
endpoint
OS in First-line BPDCN, R/R BPDCN and AML
endpoint definition
Overall survival (months) defined as the time from the date of first infusion of Tagraxofusp to the date of death from any cause
time origin
From first infusion to treatment discontinuation when survival is assessed every 90 days up to end of follow-up or death, up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML
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
NCT02113982
outcome key
om-0000
arm key
OG000
arm label
First-line BPDCN
regimen
First-line BPDCN participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day or 12 µg/kg/day in stage 1
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02113982-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT02113982
outcome key
om-0000
arm key
OG001
arm label
R/R BPDCN
regimen
R/R BPDCN who received at least 1 dose of Tagraxofusp either at 12 µg/kg/day in Stage 1
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02113982-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT02113982
outcome key
om-0000
arm key
OG002
arm label
Acute Myeloid Leukemia
regimen
AML participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day, 9 µg/kg/day, 12 µg/kg/day or 16 µg/kg/day in Stage 1
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02113982-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT02113982
outcome key
om-0001
arm key
OG000
arm label
First-line BPDCN
regimen
First-line blastic plasmacytoid dendritic cell neoplasm (BPDCN) patients enrolled in stage 3
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02113982-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT02113982
outcome key
om-0002
arm key
OG000
arm label
First-line BPDCN
regimen
First-Line BPDCN patients enrolled across stages
analyzed count
65
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02113982-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT02113982
outcome key
om-0002
arm key
OG001
arm label
R/R BPDCN
regimen
R/R BPDCN patients enrolled across stages
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02113982-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT02113982
outcome key
om-0002
arm key
OG002
arm label
Acute Myeloid Leukemia
regimen
AML patients enrolled in stage 1-2
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02113982-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT02113982
outcome key
om-0003
arm key
OG000
arm label
First-Line BPDCN
regimen
First-Line BPDCN patients enrolled across stages
analyzed count
65
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02113982-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT02113982
outcome key
om-0003
arm key
OG001
arm label
R/R BPDCN
regimen
R/R BPDCN enrolled across stages
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02113982-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT02113982
outcome key
om-0003
arm key
OG002
arm label
Acute Myeloid Leukemia
regimen
AML patients enrolled in stages 1 and 2
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02113982-om-0003#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT02113982
outcome key
om-0004
arm key
OG000
arm label
First-line BPDCN
regimen
First-line BPDCN patients enrolled across stages
analyzed count
65
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02113982-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT02113982
outcome key
om-0004
arm key
OG001
arm label
R/R BPDCN
regimen
R/R BPDCN patients enrolled across stages
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02113982-om-0004#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-blastic-plasmacytoid-dendritic-cell-neoplasm
nct id
NCT02113982
harm key
EG000
source section id
NCT02113982-ae
event group key
EG000
event group label
Stage 1 - AML Indication: 7 µg/kg/Day Dosage
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
event definition
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
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
NCT02113982
harm key
EG001
source section id
NCT02113982-ae
event group key
EG001
event group label
Stage 1 - AML Indication: 9 µg/kg/Day Dosage
serious affected
3
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
event definition
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
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
NCT02113982
harm key
EG002
source section id
NCT02113982-ae
event group key
EG002
event group label
Stage 1 - AML Indication: 12 µg/kg/Day Dosage
serious affected
2
serious at risk
2
other affected
2
other at risk
2
frequency threshold
5
collection period
From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
event definition
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
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
NCT02113982
harm key
EG003
source section id
NCT02113982-ae
event group key
EG003
event group label
Stage 1 - AML Indication: 16 µg/kg/Day Dosage
serious affected
6
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
event definition
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
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
NCT02113982
harm key
EG004
source section id
NCT02113982-ae
event group key
EG004
event group label
1L - Stage 1 - BPDCN Indication: 7 µg/kg/Day Dosage
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
event definition
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
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
NCT02113982
harm key
EG005
source section id
NCT02113982-ae
event group key
EG005
event group label
1L - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
event definition
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
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
NCT02113982
harm key
EG006
source section id
NCT02113982-ae
event group key
EG006
event group label
R/R - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
serious affected
3
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
event definition
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
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
NCT02113982
harm key
EG007
source section id
NCT02113982-ae
event group key
EG007
event group label
Stage 2 - AML Indication: 12 µg/kg/Day Dosage
serious affected
19
serious at risk
34
other affected
34
other at risk
34
frequency threshold
5
collection period
From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
event definition
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
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
NCT02113982
harm key
EG008
source section id
NCT02113982-ae
event group key
EG008
event group label
Stage 2 - AML Indication: 16 µg/kg/Day Dosage
serious affected
1
serious at risk
1
other affected
1
other at risk
1
frequency threshold
5
collection period
From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
event definition
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
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
NCT02113982
harm key
EG009
source section id
NCT02113982-ae
event group key
EG009
event group label
1L - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
serious affected
7
serious at risk
13
other affected
13
other at risk
13
frequency threshold
5
collection period
From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
event definition
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
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
NCT02113982
harm key
EG010
source section id
NCT02113982-ae
event group key
EG010
event group label
R/R - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
serious affected
6
serious at risk
10
other affected
10
other at risk
10
frequency threshold
5
collection period
From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
event definition
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
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
NCT02113982
harm key
EG011
source section id
NCT02113982-ae
event group key
EG011
event group label
1L - Stage 3 - BPDCN Indication: 12 µg/kg/Day Dosage
serious affected
4
serious at risk
13
other affected
13
other at risk
13
frequency threshold
5
collection period
From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
event definition
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

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