Trial Outcomes & Findings for Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level (NCT NCT01396070)
NCT ID: NCT01396070
Last Updated: 2017-04-05
Results Overview
Overall response rate of brentuximab vedotin in this study population.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
2 years
Results posted on
2017-04-05
Participant Flow
Participant milestones
| Measure |
Brentuximab Vedotin
Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Brentuximab Vedotin
Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Death
|
2
|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Lack of Efficacy
|
4
|
Baseline Characteristics
Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level
Baseline characteristics by cohort
| Measure |
Brentuximab Vedotin
n=36 Participants
Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
CD30 grouping at screening
< 10% CD30 positivity
|
17 participants
n=99 Participants
|
|
CD30 grouping at screening
10% to 50% CD30 positivity
|
15 participants
n=99 Participants
|
|
CD30 grouping at screening
> 50% CD30 positivity
|
4 participants
n=99 Participants
|
|
Clinical Stage
Stage IB
|
6 Participants
n=99 Participants
|
|
Clinical Stage
Stage IIB
|
16 Participants
n=99 Participants
|
|
Clinical Stage
Stage IV/SS (includes IVA, IVA/SS and III)
|
14 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The percentage was calculated by adding Complete response (CR) + Partial Response (PR) = Overall rate. 3 subjects were not evaluable.
Overall response rate of brentuximab vedotin in this study population.
Outcome measures
| Measure |
Overall Response Rate (%)
n=33 Participants
Overall Response Rate of all patients
|
|---|---|
|
Overall Response Rate (ORR)
Everyone evaluable (ORR)
|
70 percentage
|
|
Overall Response Rate (ORR)
Tissue CD30 Expression Group A
|
56 percentage
|
|
Overall Response Rate (ORR)
Tissue CD30 Expression Group B
|
79 percentage
|
|
Overall Response Rate (ORR)
Tissue CD30 Expression Group C
|
100 percentage
|
|
Overall Response Rate (ORR)
Stage IB
|
83 percentage
|
|
Overall Response Rate (ORR)
Stage IIB
|
94 percentage
|
|
Overall Response Rate (ORR)
Stage IV/SS
|
63 percentage
|
|
Overall Response Rate (ORR)
Females
|
30 percentage
|
|
Overall Response Rate (ORR)
Males
|
69 percentage
|
SECONDARY outcome
Timeframe: 2 yearsOverall Stable Disease Rate (SD) in this study population. 3 subjects were not evaluable.
Outcome measures
| Measure |
Overall Response Rate (%)
n=33 Participants
Overall Response Rate of all patients
|
|---|---|
|
Overall Stable Disease Rate
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOverall Partial Response Rate (PR) in this study population. 3 subjects were not evaluable.
Outcome measures
| Measure |
Overall Response Rate (%)
n=33 Participants
Overall Response Rate of all patients
|
|---|---|
|
Overall Partial Response Rate
|
21 Participants
|
SECONDARY outcome
Timeframe: 4 weeksOverall Non-Evaluable Response of full patient population 3 subjects were not evaluable.
Outcome measures
| Measure |
Overall Response Rate (%)
n=33 Participants
Overall Response Rate of all patients
|
|---|---|
|
Overall Non-Evaluable Response
|
4 Participants
|
Adverse Events
All Participants
Serious events: 23 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Participants
n=36 participants at risk
All reported AE's on trial
|
|---|---|
|
Infections and infestations
Sepsis
|
5.6%
2/36 • Number of events 2 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
3/36 • Number of events 3 • 4 weeks
|
|
Blood and lymphatic system disorders
Blood disorder
|
5.6%
2/36 • Number of events 5 • 4 weeks
|
|
Infections and infestations
Skin Infection
|
5.6%
2/36 • Number of events 2 • 4 weeks
|
|
Psychiatric disorders
Confusion
|
2.8%
1/36 • Number of events 1 • 4 weeks
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
5.6%
2/36 • Number of events 2 • 4 weeks
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
2.8%
1/36 • Number of events 2 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.8%
1/36 • Number of events 1 • 4 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.8%
1/36 • Number of events 4 • 4 weeks
|
|
Reproductive system and breast disorders
Pneumonia
|
2.8%
1/36 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
GVHD
|
2.8%
1/36 • Number of events 1 • 4 weeks
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
2.8%
1/36 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Acute kidney Injury
|
2.8%
1/36 • Number of events 2 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Infection and Pain of skin
|
2.8%
1/36 • Number of events 2 • 4 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.8%
1/36 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Vomitting
|
2.8%
1/36 • Number of events 1 • 4 weeks
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
2.8%
1/36 • Number of events 1 • 4 weeks
|
Other adverse events
| Measure |
All Participants
n=36 participants at risk
All reported AE's on trial
|
|---|---|
|
Nervous system disorders
Peripheral Neuropathy
|
5.6%
2/36 • Number of events 2 • 4 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
3/36 • Number of events 3 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Skin eruption
|
11.1%
4/36 • Number of events 4 • 4 weeks
|
|
Social circumstances
Weight Loss
|
8.3%
3/36 • Number of events 3 • 4 weeks
|
|
Blood and lymphatic system disorders
Aberrant T-cell population (blood)
|
5.6%
2/36 • Number of events 2 • 4 weeks
|
|
Blood and lymphatic system disorders
Dysphonia
|
5.6%
2/36 • Number of events 2 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
2/36 • Number of events 2 • 4 weeks
|
|
Blood and lymphatic system disorders
Hyponatremia
|
5.6%
2/36 • Number of events 2 • 4 weeks
|
|
General disorders
Infusion Reaction
|
5.6%
2/36 • Number of events 2 • 4 weeks
|
|
Investigations
Leukopenia
|
5.6%
2/36 • Number of events 2 • 4 weeks
|
|
General disorders
Lower extremity edema
|
5.6%
2/36 • Number of events 2 • 4 weeks
|
|
Investigations
LFTs elevated
|
5.6%
2/36 • Number of events 2 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
5.6%
2/36 • Number of events 2 • 4 weeks
|
|
General disorders
Pain
|
5.6%
2/36 • Number of events 2 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place