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A Phase II Study of Carfilzomib in the Treatment of Relapsed/Refractory Mantle Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT02042950
Recruitment Status : Terminated (Terminated due to poor accrual)
First Posted : January 23, 2014
Results First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
Onyx Therapeutics, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Intervention Drug: Carfilzomib
Enrollment 6
Recruitment Details  
Pre-assignment Details Out of 6 enrolled participants 2 failed screening.
Arm/Group Title Carfilzomib
Hide Arm/Group Description To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
Period Title: Overall Study
Started 4
Completed 0
Not Completed 4
Reason Not Completed
Progressive Disease             4
Arm/Group Title Carfilzomib
Hide Arm/Group Description To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  25.0%
>=65 years
3
  75.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
1
  25.0%
Male
3
  75.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Hispanic or Latino
1
  25.0%
Not Hispanic or Latino
3
  75.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Overall Response Rate of Carfilzomib
Hide Description To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
Time Frame 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
Unable to complete final analysis due to not meeting enrollment requirements.
Arm/Group Title Carfilzomib
Hide Arm/Group Description:
To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Other Pre-specified Outcome
Title Toxicity of Carfilzomib
Hide Description To further evaluate the toxicity of Carfilzomib in patients
Time Frame 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
Unable to complete final analysis due to not meeting enrollment requirements.
Arm/Group Title Carfilzomib
Hide Arm/Group Description:
To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Other Pre-specified Outcome
Title Post Treatment
Hide Description To estimate the response duration, progression free survival, time to failure and overall survival.
Time Frame 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
Unable to complete final analysis due to not meeting enrollment requirements.
Arm/Group Title Carfilzomib
Hide Arm/Group Description:
To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 21 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carfilzomib
Hide Arm/Group Description To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
All-Cause Mortality
Carfilzomib
Affected / at Risk (%)
Total   0/4 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Carfilzomib
Affected / at Risk (%) # Events
Total   2/4 (50.00%)    
Infections and infestations   
Upper Respiratory Infection  1  1/4 (25.00%)  1
Vascular disorders   
Hypotension  1  1/4 (25.00%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Carfilzomib
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  3/4 (75.00%)  5
Endocrine disorders   
Adrenal Insufficiency  1  1/4 (25.00%)  1
Eye disorders   
Blurred Vision  1  2/4 (50.00%)  2
Dry Eyes  1  1/4 (25.00%)  2
Gastrointestinal disorders   
Constipation  1  1/4 (25.00%)  1
Diarrhea  1  2/4 (50.00%)  2
Mucositis  1  1/4 (25.00%)  1
Nausea  1  2/4 (50.00%)  2
General disorders   
Edema Limbs  1  1/4 (25.00%)  1
Fatigue  1  4/4 (100.00%)  7
Fever  1  1/4 (25.00%)  1
Investigations   
Alk Phos Increase  1  1/4 (25.00%)  1
AST Increase  1  1/4 (25.00%)  1
Bili Rubin Increase  1  1/4 (25.00%)  1
Creatinine Increase  1  2/4 (50.00%)  2
Neutrophil Decrease  1  1/4 (25.00%)  3
Platelet Count Decrease  1  4/4 (100.00%)  9
White Blood Cell Decrease  1  3/4 (75.00%)  5
Metabolism and nutrition disorders   
Dehydration  1  2/4 (50.00%)  2
Elevated BUN  1  3/4 (75.00%)  4
Elevated Lactic Acids  1  1/4 (25.00%)  1
Hyperglycemia  1  3/4 (75.00%)  3
Hyperhidrosis  1  1/4 (25.00%)  1
Hyperkalemia  1  2/4 (50.00%)  2
Hypertension  1  1/4 (25.00%)  1
Hyperuricemia  1  2/4 (50.00%)  2
Hypoalbuminemia  1  2/4 (50.00%)  2
Hypocalemia  1  1/4 (25.00%)  1
Hypoglycemia  1  1/4 (25.00%)  1
Hypomagnesium  1  1/4 (25.00%)  1
Hyponatremia  1  1/4 (25.00%)  1
Musculoskeletal and connective tissue disorders   
Myalgia  1  2/4 (50.00%)  3
Pain  1  2/4 (50.00%)  3
Nervous system disorders   
Dizziness  1  2/4 (50.00%)  3
Memory Impairment  1  1/4 (25.00%)  1
Peripheral Sensory Neuropathy  1  1/4 (25.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/4 (50.00%)  2
Dyspnea  1  2/4 (50.00%)  3
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Hun Ju Lee/ Assistant Professor, Lymphoma/Myeloma
Organization: UT MD Anderson Cancer Center
Phone: (713) 794-1829
EMail: hunlee@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02042950     History of Changes
Other Study ID Numbers: 2013-0259
NCI-2014-01271 ( Registry Identifier: NCI CTRP )
First Submitted: January 21, 2014
First Posted: January 23, 2014
Results First Submitted: April 9, 2019
Results First Posted: May 1, 2019
Last Update Posted: May 1, 2019