Trial Outcomes & Findings for An Open-label Phase II Study of Lorvotuzumab Mertansine (NCT NCT02420873)
NCT ID: NCT02420873
Last Updated: 2018-08-28
Results Overview
ORR, defined as CR (complete remission) + CRp (complete remission with incomplete platelet recovery) + CRi (complete remission with incomplete count recovery) within 3 cycles of therapy with IMGN901.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
53 days
Results posted on
2018-08-28
Participant Flow
May 2015 through July 2016. All of the participants were recruited at The University of Texas (UT) MD Anderson Cancer Center.
All of the participants registered on this study have CD56 expressing hematological malignancies and were assigned to cohort 1 of this study. No participants registered on this study had a diagnosis of Myelofibrosis or Blastic Plasmacytoid Dendritic Cell Neoplasms, Therefore, zero participants were analyzed on cohort 2 or cohort 3 of this study.
Participant milestones
| Measure |
Cohort 1: CD56 Expressing Hematological Malignancies
Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.
Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
|
Cohort 2: Myelofibrosis
Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.
Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
|
Cohort 3: Blastic Plasmacytoid Dendritic Cell Neoplasm
Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.
Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
0
|
0
|
|
Overall Study
COMPLETED
|
9
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-label Phase II Study of Lorvotuzumab Mertansine
Baseline characteristics by cohort
| Measure |
Cohort 1: CD56 Expressing Hematological Malignancies
n=9 Participants
Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.
Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
|
Cohort 2: Myelofibrosis
Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.
Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
|
Cohort 3: Blastic Plasmacytoid Dendritic Cell Neoplasm
Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.
Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Age, Continuous
|
58 years
n=93 Participants
|
—
|
—
|
58 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=93 Participants
|
—
|
—
|
9 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 53 daysPopulation: Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
ORR, defined as CR (complete remission) + CRp (complete remission with incomplete platelet recovery) + CRi (complete remission with incomplete count recovery) within 3 cycles of therapy with IMGN901.
Outcome measures
| Measure |
Cohort 1: CD56 Expressing Hematological Malignancies
n=9 Participants
Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.
Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
|
Cohort 2: Myelofibrosis
Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.
Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
|
Cohort 3: Blastic Plasmacytoid Dendritic Cell Neoplasm
Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.
Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
|
|---|---|---|---|
|
Overall Response Rate (ORR) of IMGN901 in Participants CD56 Expressing Hematological Malignancies
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1: CD56 Expressing Hematological Malignancies
Serious events: 9 serious events
Other events: 6 other events
Deaths: 4 deaths
Cohort 2: Myelofibrosis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3: Blastic Plasmacytoid Dendritic Cell Neoplasm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: CD56 Expressing Hematological Malignancies
n=9 participants at risk
Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.
Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
|
Cohort 2: Myelofibrosis
Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.
Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
|
Cohort 3: Blastic Plasmacytoid Dendritic Cell Neoplasm
Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.
Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
|
|---|---|---|---|
|
General disorders
Abdominal Pain
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
General disorders
Death
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Infections and infestations
Enterocolitis
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Infections and infestations
Febrile Neutropenia
|
33.3%
3/9 • Number of events 3 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Infections and infestations
Lung Infection
|
22.2%
2/9 • Number of events 2 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
General disorders
Multi-Organ Failure
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Infections and infestations
Sepsis
|
22.2%
2/9 • Number of events 2 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Infections and infestations
Urinary Tract Infection
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Infections and infestations
Vulval Infection
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
Other adverse events
| Measure |
Cohort 1: CD56 Expressing Hematological Malignancies
n=9 participants at risk
Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.
Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
|
Cohort 2: Myelofibrosis
Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.
Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
|
Cohort 3: Blastic Plasmacytoid Dendritic Cell Neoplasm
Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.
Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
|
|---|---|---|---|
|
General disorders
Abdominal Pain
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Infections and infestations
Febrile Neutropenia
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Infections and infestations
Lung Infection
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Infections and infestations
Cellulitis Leg
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Metabolism and nutrition disorders
Increased Alanine Aminotransferase (ALT)
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Gastrointestinal disorders
Anorexia
|
33.3%
3/9 • Number of events 3 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Nervous system disorders
Anxiety
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Metabolism and nutrition disorders
Aspartate Aminotransferase (AST)
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
General disorders
Back Pain
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
General disorders
Bone Pain
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • Number of events 2 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
General disorders
Cough
|
22.2%
2/9 • Number of events 2 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
2/9 • Number of events 2 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Gastrointestinal disorders
Dry Mouth
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
2/9 • Number of events 2 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
General disorders
Ear Pain
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Blood and lymphatic system disorders
Edema Limbs
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Vascular disorders
Epistaxis
|
22.2%
2/9 • Number of events 2 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
General disorders
Fever
|
22.2%
2/9 • Number of events 2 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.1%
1/9 • Number of events 2 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
1/9 • Number of events 2 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
General disorders
Hypophosphatemia
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Cardiac disorders
Hypotension
|
22.2%
2/9 • Number of events 2 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Vascular disorders
Hypoxia
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
General disorders
Malaise
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
General disorders
numbness
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
General disorders
Pain
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Nervous system disorders
Neuropathy
|
44.4%
4/9 • Number of events 4 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
|
Cardiac disorders
Sinus Tachycardia
|
11.1%
1/9 • Number of events 1 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
—
0/0 • Adverse events reported during each treatment course. Overall period: May 2015 to April 2016.
Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).
|
Additional Information
Naval Daver, MD/ Associate Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-794-4392
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place