Trial Outcomes & Findings for A Phase II Study of Carfilzomib in the Treatment of Relapsed/Refractory Mantle Cell Lymphoma (NCT NCT02042950)
NCT ID: NCT02042950
Last Updated: 2019-05-01
Results Overview
To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
21 months
Results posted on
2019-05-01
Participant Flow
Out of 6 enrolled participants 2 failed screening.
Participant milestones
| Measure |
Carfilzomib
To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Carfilzomib
To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
|
|---|---|
|
Overall Study
Progressive Disease
|
4
|
Baseline Characteristics
A Phase II Study of Carfilzomib in the Treatment of Relapsed/Refractory Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Carfilzomib
n=4 Participants
To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 monthsPopulation: Unable to complete final analysis due to not meeting enrollment requirements.
To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 21 monthsPopulation: Unable to complete final analysis due to not meeting enrollment requirements.
To further evaluate the toxicity of Carfilzomib in patients
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 21 monthsPopulation: Unable to complete final analysis due to not meeting enrollment requirements.
To estimate the response duration, progression free survival, time to failure and overall survival.
Outcome measures
Outcome data not reported
Adverse Events
Carfilzomib
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carfilzomib
n=4 participants at risk
To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
|
|---|---|
|
Infections and infestations
Upper Respiratory Infection
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • 21 months
|
Other adverse events
| Measure |
Carfilzomib
n=4 participants at risk
To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
|
|---|---|
|
Endocrine disorders
Adrenal Insufficiency
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Investigations
Alk Phos Increase
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
3/4 • Number of events 5 • 21 months
|
|
Investigations
AST Increase
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Investigations
Bili Rubin Increase
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Eye disorders
Blurred Vision
|
50.0%
2/4 • Number of events 2 • 21 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Number of events 2 • 21 months
|
|
Investigations
Creatinine Increase
|
50.0%
2/4 • Number of events 2 • 21 months
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
2/4 • Number of events 2 • 21 months
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 2 • 21 months
|
|
Nervous system disorders
Dizziness
|
50.0%
2/4 • Number of events 3 • 21 months
|
|
Eye disorders
Dry Eyes
|
25.0%
1/4 • Number of events 2 • 21 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
2/4 • Number of events 3 • 21 months
|
|
General disorders
Edema Limbs
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Metabolism and nutrition disorders
Elevated BUN
|
75.0%
3/4 • Number of events 4 • 21 months
|
|
Metabolism and nutrition disorders
Elevated Lactic Acids
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
General disorders
Fatigue
|
100.0%
4/4 • Number of events 7 • 21 months
|
|
General disorders
Fever
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
75.0%
3/4 • Number of events 3 • 21 months
|
|
Metabolism and nutrition disorders
Hyperhidrosis
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
50.0%
2/4 • Number of events 2 • 21 months
|
|
Metabolism and nutrition disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
50.0%
2/4 • Number of events 2 • 21 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
2/4 • Number of events 2 • 21 months
|
|
Metabolism and nutrition disorders
Hypocalemia
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Metabolism and nutrition disorders
Hypomagnesium
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Nervous system disorders
Memory Impairment
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Gastrointestinal disorders
Mucositis
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
2/4 • Number of events 3 • 21 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2 • 21 months
|
|
Investigations
Neutrophil Decrease
|
25.0%
1/4 • Number of events 3 • 21 months
|
|
Musculoskeletal and connective tissue disorders
Pain
|
50.0%
2/4 • Number of events 3 • 21 months
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
25.0%
1/4 • Number of events 1 • 21 months
|
|
Investigations
Platelet Count Decrease
|
100.0%
4/4 • Number of events 9 • 21 months
|
|
Investigations
White Blood Cell Decrease
|
75.0%
3/4 • Number of events 5 • 21 months
|
Additional Information
Dr. Hun Ju Lee/ Assistant Professor, Lymphoma/Myeloma
UT MD Anderson Cancer Center
Phone: (713) 794-1829
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place