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Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01980628
Recruitment Status : Completed
First Posted : November 11, 2013
Results First Posted : February 10, 2017
Last Update Posted : October 16, 2019
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Marginal Zone Lymphoma
B-cell Lymphoma
Intervention Drug: ibrutinib
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ibrutinib
Hide Arm/Group Description Subjects receive daily dose of 560 mg of ibrutinib capsules.
Period Title: Overall Study
Started 63 [1]
Completed 0 [2]
Not Completed 63
Reason Not Completed
Adverse Event             12
Physician Decision             5
Withdrawal by Subject             4
PD, Subj non-Compliant,Study Terminated             42
[1]
Total number of patients enrolled to the study and received study treatment
[2]
Participants who remain on treatment at Final Analysis.
Arm/Group Title Ibrutinib
Hide Arm/Group Description Subjects receive a daily dose of 560 mg of ibrutinib capsules
Overall Number of Baseline Participants 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
<=18 years 0
Between 18 and 65 years 27
>=65 years 36
[1]
Measure Description: Participants were required to be of age 18 years or older
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Female
37
  58.7%
Male
26
  41.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
White
53
  84.1%
Black
6
   9.5%
Asian
1
   1.6%
Unknown
3
   4.8%
1.Primary Outcome
Title ORR (Overall Response Rate)
Hide Description

ORR is defined as the proportion of subjects who achieved complete response (CR), partial response (PR). Response criteria are as outlined in the International Working Group Criteria for NHL, Cheson (2007), with disease assessments performed by an independent review committee (IRC).

Per Cheson:

CR is defined as disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites.

Time Frame Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm, Intent to Treat Population
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 63
Mean (95% Confidence Interval)
Unit of Measure: Percentage of Participants
46
(33.5 to 59.3)
2.Secondary Outcome
Title DOR (Duration of Response)
Hide Description The DOR analyses is performed on the subset of subjects that achieve CR or PR as determined by IRC. DOR is calculated as the duration of time from the date of first response to the date of progression or death due to any cause.
Time Frame Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibrutinib
Hide Arm/Group Description:
Patients receive daily dose of 560 mg of ibrutinib capsules.
Overall Number of Participants Analyzed 63
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(16.7 to NA)
[1]
Per IRC assessment, the median DOR was not reached
Time Frame From the time of first ibrutinib dose until 30 days following the last dose of study drug
Adverse Event Reporting Description For “At Risk” we considered 60 because it was the efficacy population (with N=60) is used for OS
 
Arm/Group Title Ibrutinib
Hide Arm/Group Description ibrutinib capsules: 560 mg once daily
All-Cause Mortality
Ibrutinib
Affected / at Risk (%)
Total   17/63 (26.98%) 
Hide Serious Adverse Events
Ibrutinib
Affected / at Risk (%)
Total   29/63 (46.03%) 
Blood and lymphatic system disorders   
Autoimmune Haemolytic Anaemia  2/63 (3.17%) 
Haemolytic Anaemia  1/63 (1.59%) 
Cardiac disorders   
Atrial Fibrillation  1/63 (1.59%) 
Pericardial Effusion  1/63 (1.59%) 
Cardiac Failure Congestive *  1/63 (1.59%) 
Gastrointestinal disorders   
Pancreatitis  1/63 (1.59%) 
Stomatitis  1/63 (1.59%) 
General disorders   
Asthenia  1/63 (1.59%) 
Multiple Organ Dysfunction Syndrome  1/63 (1.59%) 
Non-Cardiac Chest Pain  1/63 (1.59%) 
Pyrexia  1/63 (1.59%) 
Hepatobiliary disorders   
Cholelithiasis  1/63 (1.59%) 
Infections and infestations   
Pneumonia  5/63 (7.94%) 
Cellulitis  2/63 (3.17%) 
Sepsis  2/63 (3.17%) 
Escherichia Sepsis  1/63 (1.59%) 
Infection  1/63 (1.59%) 
Influenza  1/63 (1.59%) 
Listeria Sepsis  1/63 (1.59%) 
Lung Infection  1/63 (1.59%) 
Parainfluenzae Virus Infection  1/63 (1.59%) 
Injury, poisoning and procedural complications   
Ankle Fracture  1/63 (1.59%) 
Bronchial Injury *  1/63 (1.59%) 
Metabolism and nutrition disorders   
Dehydration  1/63 (1.59%) 
Fluid Overload  1/63 (1.59%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lymphoma  1/63 (1.59%) 
Marginal Zone Lymphoma  1/63 (1.59%) 
Nervous system disorders   
Cerebral Haemorrhage  1/63 (1.59%) 
Cervical Radiculopathy  1/63 (1.59%) 
Transient Ischaemic Attack  1/63 (1.59%) 
Renal and urinary disorders   
Acute Kidney Injury  1/63 (1.59%) 
Respiratory, thoracic and mediastinal disorders   
Pneumothorax  1/63 (1.59%) 
Dyspnoea  1/63 (1.59%) 
Eosinophilic Pneumonia  1/63 (1.59%) 
Hypoxia  1/63 (1.59%) 
Pleural Effusion  1/63 (1.59%) 
Pneumonitis  1/63 (1.59%) 
Pulmonary Embolism  1/63 (1.59%) 
Respiratory Failure  1/63 (1.59%) 
Haemoptysis  1/63 (1.59%) 
Organising Pneumonia  1/63 (1.59%) 
Vascular disorders   
Hypotension  1/63 (1.59%) 
Embolism  1/63 (1.59%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ibrutinib
Affected / at Risk (%)
Total   63/63 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  23/63 (36.51%) 
Thrombocytopenia  15/63 (23.81%) 
Increased Tendency To Bruise  12/63 (19.05%) 
Cardiac disorders   
Atrial Fibrillation  5/63 (7.94%) 
Eye disorders   
Vision Blurred  4/63 (6.35%) 
Dry Eye  4/63 (6.35%) 
Gastrointestinal disorders   
Diarrhoea  30/63 (47.62%) 
Nausea  20/63 (31.75%) 
Dyspepsia  12/63 (19.05%) 
Abdominal Pain  10/63 (15.87%) 
Constipation  10/63 (15.87%) 
Abdominal Pain Upper  7/63 (11.11%) 
Stomatitis  8/63 (12.70%) 
Vomiting  7/63 (11.11%) 
Abdominal Discomfort  4/63 (6.35%) 
Abdominal Distension  4/63 (6.35%) 
General disorders   
Fatigue  29/63 (46.03%) 
Oedema Peripheral  15/63 (23.81%) 
Pyrexia  12/63 (19.05%) 
Asthenia  6/63 (9.52%) 
Pain  4/63 (6.35%) 
Infections and infestations   
Upper Respiratory Tract Infection  16/63 (25.40%) 
Sinusitis  13/63 (20.63%) 
Bronchitis  7/63 (11.11%) 
Urinary Tract Infection  9/63 (14.29%) 
Oral Herpes  5/63 (7.94%) 
Conjunctivitis  4/63 (6.35%) 
Cystitis  4/63 (6.35%) 
Cellulitis  7/63 (11.11%) 
Pneumonia  6/63 (9.52%) 
Ear Infection  4/63 (6.35%) 
Viral Upper Respiratory tract  4/63 (6.35%) 
Injury, poisoning and procedural complications   
Fall  10/63 (15.87%) 
Contusion  7/63 (11.11%) 
Skin Abrasion  6/63 (9.52%) 
Investigations   
Weight Decreased  9/63 (14.29%) 
Blood Alkaline Phosphatase Increased  5/63 (7.94%) 
Blood Creatinine Increased  4/63 (6.35%) 
Metabolism and nutrition disorders   
Decreased Appetite  11/63 (17.46%) 
Hyperglycaemia  10/63 (15.87%) 
Hyperuricaemia  10/63 (15.87%) 
Hypoalbuminaemia  11/63 (17.46%) 
Hypokalaemia  9/63 (14.29%) 
Hypocalcaemia  7/63 (11.11%) 
Hyponatraemia  5/63 (7.94%) 
Dehydration  4/63 (6.35%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  15/63 (23.81%) 
Muscle Spasms  13/63 (20.63%) 
Pain In Extremity  10/63 (15.87%) 
Back Pain  7/63 (11.11%) 
Musculoskeletal Pain  5/63 (7.94%) 
Myalgia  4/63 (6.35%) 
Joint Swelling  4/63 (6.35%) 
Nervous system disorders   
Dizziness  14/63 (22.22%) 
Headache  13/63 (20.63%) 
Psychiatric disorders   
Anxiety  11/63 (17.46%) 
Depression  4/63 (6.35%) 
Renal and urinary disorders   
Haematuria  7/63 (11.11%) 
Dysuria  4/63 (6.35%) 
Respiratory, thoracic and mediastinal disorders   
Cough  16/63 (25.40%) 
Dyspnoea  13/63 (20.63%) 
Epistaxis  8/63 (12.70%) 
Nasal Congestion  6/63 (9.52%) 
Oropharyngeal Pain  4/63 (6.35%) 
Productive Cough  4/63 (6.35%) 
Rhinorrhoea  4/63 (6.35%) 
Sinus Congestion  3/63 (4.76%) 
Pleural Effusion  5/63 (7.94%) 
Skin and subcutaneous tissue disorders   
Rash Maculo-Papular  11/63 (17.46%) 
Pruritus  9/63 (14.29%) 
Ecchymosis  6/63 (9.52%) 
Night Sweats  6/63 (9.52%) 
Alopecia  5/63 (7.94%) 
Dry Skin  4/63 (6.35%) 
Erythema  4/63 (6.35%) 
Rash Erythematous  4/63 (6.35%) 
Hyperhidrosis  4/63 (6.35%) 
Petechiae  4/63 (6.35%) 
Vascular disorders   
Hypertension  10/63 (15.87%) 
Hypotension  4/63 (6.35%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Agreement restrictions can vary and typically include (but are not limited to):

Required submission of all material for sponsor review at least thirty days prior to the proposed date of any presentation or submission. Materials must remove Proprietary Information, excluding Data /Study results. All Sponsor's comments are required to be included. Sponsor may delay the presentation/submission upon Sponsor review of materials that are being proposed for presentation/submission.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Isaiah Dimery, MD, Senior Medical Director
Organization: Pharmacyclics, LLC
Phone: 408-215-3579
EMail: idimery@pcyc.com
Layout table for additonal information
Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT01980628    
Other Study ID Numbers: PCYC-1121-CA
First Submitted: October 29, 2013
First Posted: November 11, 2013
Results First Submitted: December 20, 2016
Results First Posted: February 10, 2017
Last Update Posted: October 16, 2019