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A Multicenter Phase 2 Study of Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion

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: NCT01744691
Recruitment Status : Completed
First Posted : December 7, 2012
Results First Posted : June 9, 2015
Last Update Posted : February 27, 2017
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Lymphocytic Leukemia With 17p Deletion
Small Lymphocytic Lymphoma With 17p Deletion
Intervention Drug: Ibrutinib
Enrollment 145
Recruitment Details  
Pre-assignment Details One hundred forty-five subjects were enrolled and 144 subjects received at least 1 dose of PCI-32765 and constitute the all treated population and the safety analysis set.
Arm/Group Title Ibrutinib
Hide Arm/Group Description

All subjects received ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.

Ibrutinib: All subjects received ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.

Period Title: Overall Study
Started 144 [1]
Completed 101 [2]
Not Completed 43
Reason Not Completed
Progressive Disease             18
Unacceptable toxicity, AE or death             18
Withdrawal of consent for treatment             3
Physician Decision             4
[1]
Participants who received study treatment
[2]
Participants who were on study treatment at the time of the primary analysis
Arm/Group Title PCI-32765
Hide Arm/Group Description

All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.

PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.

Overall Number of Baseline Participants 144
Hide Baseline Analysis Population Description
One hundred forty-five subjects were enrolled and 144 subjects received at least 1 dose of PCI-32765 and constitute the all treated population and the safety analysis set.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 144 participants
<=18 years
0
   0.0%
Between 18 and 65 years
75
  52.1%
>=65 years
69
  47.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 144 participants
64.4  (9.9)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 144 participants
Female
48
  33.3%
Male
96
  66.7%
1.Primary Outcome
Title Overall Response Rate
Hide Description The primary objective of this study is to evaluate the efficacy of ibrutinib in terms of ORR according to an Independent Review Committee (IRC). ORR based upon IRC assessment is the proportion of responders in the all treated population. Responders were subjects who achieved partial response (PR) or better, ie, complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR, per IWCLL 2008 criteria with the clarification for treatment-related lymphocytosis.
Time Frame The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed on all 144 treated subjects. The primary analysis (PA) used IRC assessment of efficacy endpoints. In the PA, there were no differences between the IRC and investigator responses. IRC assessment was no longer performed after the PA and the final analysis result report investigator-assessed efficacy outcomes.
Arm/Group Title Ibrutinib
Hide Arm/Group Description:

All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.

ibrutinib: All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.

Overall Number of Participants Analyzed 144
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % of participants with response by PI
77.8
(70.3 to 83.8)
2.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs)
Hide Description Number of participants who had experienced at least one treatment emergent AE
Time Frame From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of PCI-32765 and constitute the all treated population.
Arm/Group Title PCI-32765
Hide Arm/Group Description:

All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.

PCI-32765: All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.

Overall Number of Participants Analyzed 144
Measure Type: Number
Unit of Measure: participants
144
Time Frame From first dose of PCI-32765 to within 30 days of last dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PCI-32765
Hide Arm/Group Description

All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.

PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.

All-Cause Mortality
PCI-32765
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
PCI-32765
Affected / at Risk (%)
Total   76/144 (52.78%) 
Blood and lymphatic system disorders   
Anaemia  1  4/144 (2.78%) 
Febrile neutropenia  1  2/144 (1.39%) 
Autoimmune haemolytic anaemia  1  1/144 (0.69%) 
Coagulopathy  1  1/144 (0.69%) 
Haemolytic anaemia  1  1/144 (0.69%) 
Immune thrombocytopenic purpura  1  1/144 (0.69%) 
Iron deficiency anaemia  1  1/144 (0.69%) 
Spontaneous haematoma  1  1/144 (0.69%) 
Thrombocytopenia  1  1/144 (0.69%) 
Cardiac disorders   
Atrial fibrillation  1  8/144 (5.56%) 
Acute myocardial infarction  1  2/144 (1.39%) 
Pericarditis  1  2/144 (1.39%) 
Cardiac failure  1  1/144 (0.69%) 
Myocardial infarction  1  1/144 (0.69%) 
Pericardial effusion  1  1/144 (0.69%) 
Sinus node dysfunction  1  1/144 (0.69%) 
Eye disorders   
Iritis  1  1/144 (0.69%) 
Gastrointestinal disorders   
Colitis  1  2/144 (1.39%) 
Diarrhoea  1  2/144 (1.39%) 
Colitis ischaemic  1  1/144 (0.69%) 
Gastric ulcer haemorrhage  1  1/144 (0.69%) 
Gastritis  1  1/144 (0.69%) 
Intestinal obstruction  1  1/144 (0.69%) 
Oral mucosal blistering  1  1/144 (0.69%) 
Stomatitis  1  1/144 (0.69%) 
Upper gastrointestinal haemorrhage  1  1/144 (0.69%) 
Vomiting  1  1/144 (0.69%) 
General disorders   
Pyrexia  1  3/144 (2.08%) 
Fatigue  1  2/144 (1.39%) 
Asthenia  1  1/144 (0.69%) 
General physical health deterioration  1  1/144 (0.69%) 
Localised oedema  1  1/144 (0.69%) 
Oedema peripheral  1  1/144 (0.69%) 
Hepatobiliary disorders   
Cholecystitis  1  2/144 (1.39%) 
Cholecystitis acute  1  1/144 (0.69%) 
Hepatic function abnormal  1  1/144 (0.69%) 
Infections and infestations   
Pneumonia  1  21/144 (14.58%) 
Urinary tract infection  1  5/144 (3.47%) 
Cellulitis  1  4/144 (2.78%) 
Bronchitis  1  2/144 (1.39%) 
Pyelonephritis  1  2/144 (1.39%) 
Sepsis  1  2/144 (1.39%) 
Septic shock  1  2/144 (1.39%) 
Appendicitis  1  1/144 (0.69%) 
Aspergillus infection  1  1/144 (0.69%) 
Atypical pneumonia  1  1/144 (0.69%) 
Bacteraemia  1  1/144 (0.69%) 
Campylobacter gastroenteritis  1  1/144 (0.69%) 
Cystitis  1  1/144 (0.69%) 
Empyema  1  1/144 (0.69%) 
Epiglottitis  1  1/144 (0.69%) 
Gastroenteritis clostridial  1  1/144 (0.69%) 
Groin abscess  1  1/144 (0.69%) 
Herpes simplex  1  1/144 (0.69%) 
Influenza  1  1/144 (0.69%) 
Lower respiratory tract infection viral  1  1/144 (0.69%) 
Lung infection  1  1/144 (0.69%) 
Lymphadenitis bacterial  1  1/144 (0.69%) 
Oropharyngeal candidiasis  1  1/144 (0.69%) 
Pneumocystis jirovecii pneumonia  1  1/144 (0.69%) 
Sinusitis fungal  1  1/144 (0.69%) 
Staphylococcal sepsis  1  1/144 (0.69%) 
Subcutaneous abscess  1  1/144 (0.69%) 
Varicella zoster virus infection  1  1/144 (0.69%) 
Injury, poisoning and procedural complications   
Subdural haematoma  1  3/144 (2.08%) 
Alcohol poisoning  1  1/144 (0.69%) 
Femoral neck fracture  1  1/144 (0.69%) 
Meniscus injury  1  1/144 (0.69%) 
Muscle rupture  1  1/144 (0.69%) 
Post procedural haematuria  1  1/144 (0.69%) 
Post procedural haemorrhage  1  1/144 (0.69%) 
Traumatic haematoma  1  1/144 (0.69%) 
Metabolism and nutrition disorders   
Hypercalcaemia  1  1/144 (0.69%) 
Hyperkalaemia  1  1/144 (0.69%) 
Hypomagnesaemia  1  1/144 (0.69%) 
Hyponatraemia  1  1/144 (0.69%) 
Musculoskeletal and connective tissue disorders   
Arthritis  1  2/144 (1.39%) 
Myalgia  1  2/144 (1.39%) 
Osteoporosis  1  2/144 (1.39%) 
Arthralgia  1  1/144 (0.69%) 
Chondromalacia  1  1/144 (0.69%) 
Dactylitis  1  1/144 (0.69%) 
Muscular weakness  1  1/144 (0.69%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Richter's syndrome  1  6/144 (4.17%) 
Chronic lymphocytic leukaemia  1  5/144 (3.47%) 
Basal cell carcinoma  1  2/144 (1.39%) 
Hodgkin's disease  1  2/144 (1.39%) 
B-cell small lymphocytic lymphoma  1  1/144 (0.69%) 
Lymphoma transformation  1  1/144 (0.69%) 
Skin papilloma  1  1/144 (0.69%) 
Squamous cell carcinoma of skin  1  1/144 (0.69%) 
Vulval cancer stage 0  1  1/144 (0.69%) 
Nervous system disorders   
Syncope  1  2/144 (1.39%) 
Cerebrovascular accident  1  1/144 (0.69%) 
Critical illness polyneuropathy  1  1/144 (0.69%) 
Encephalopathy  1  1/144 (0.69%) 
Haemorrhage intracranial  1  1/144 (0.69%) 
Psychiatric disorders   
Psychotic disorder  1  1/144 (0.69%) 
Renal and urinary disorders   
Acute kidney injury  1  2/144 (1.39%) 
Renal failure  1  2/144 (1.39%) 
Renal infarct  1  1/144 (0.69%) 
Reproductive system and breast disorders   
Prostatomegaly  1  1/144 (0.69%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  3/144 (2.08%) 
Alveolitis allergic  1  1/144 (0.69%) 
Haemoptysis  1  1/144 (0.69%) 
Haemothorax  1  1/144 (0.69%) 
Interstitial lung disease  1  1/144 (0.69%) 
Pneumonitis  1  1/144 (0.69%) 
Pulmonary embolism  1  1/144 (0.69%) 
Pulmonary mass  1  1/144 (0.69%) 
Pulmonary oedema  1  1/144 (0.69%) 
Skin and subcutaneous tissue disorders   
Livedo reticularis  1  1/144 (0.69%) 
Skin erosion  1  1/144 (0.69%) 
Stevens-Johnson syndrome  1  1/144 (0.69%) 
Trichodysplasia spinulosa  1  1/144 (0.69%) 
Vascular disorders   
Arterial haemorrhage  1  1/144 (0.69%) 
Hypertension  1  1/144 (0.69%) 
Orthostatic hypotension  1  1/144 (0.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PCI-32765
Affected / at Risk (%)
Total   144/144 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  33/144 (22.92%) 
Neutropenia  1  29/144 (20.14%) 
Increased tendency to bruise  1  23/144 (15.97%) 
Thrombocytopenia  1  21/144 (14.58%) 
Spontaneous haematoma  1  8/144 (5.56%) 
Cardiac disorders   
Atrial fibrillation  1  16/144 (11.11%) 
Eye disorders   
Vision blurred  1  16/144 (11.11%) 
Visual acuity reduced  1  12/144 (8.33%) 
Dry eye  1  11/144 (7.64%) 
Lacrimation increased  1  11/144 (7.64%) 
Eye irritation  1  8/144 (5.56%) 
Gastrointestinal disorders   
Diarrhoea  1  63/144 (43.75%) 
Nausea  1  34/144 (23.61%) 
Constipation  1  21/144 (14.58%) 
Dyspepsia  1  18/144 (12.50%) 
Vomiting  1  17/144 (11.81%) 
Abdominal pain  1  14/144 (9.72%) 
Stomatitis  1  11/144 (7.64%) 
Abdominal pain upper  1  8/144 (5.56%) 
Gastrooesophageal reflux disease  1  8/144 (5.56%) 
General disorders   
Fatigue  1  54/144 (37.50%) 
Pyrexia  1  31/144 (21.53%) 
Oedema peripheral  1  28/144 (19.44%) 
Chills  1  9/144 (6.25%) 
Peripheral swelling  1  9/144 (6.25%) 
Infections and infestations   
Upper respiratory tract infection  1  30/144 (20.83%) 
Urinary tract infection  1  30/144 (20.83%) 
Pneumonia  1  28/144 (19.44%) 
Nasopharyngitis  1  18/144 (12.50%) 
Sinusitis  1  16/144 (11.11%) 
Bronchitis  1  14/144 (9.72%) 
Cellulitis  1  9/144 (6.25%) 
Injury, poisoning and procedural complications   
Contusion  1  10/144 (6.94%) 
Fall  1  8/144 (5.56%) 
Investigations   
Weight increased  1  20/144 (13.89%) 
Weight decreased  1  16/144 (11.11%) 
Metabolism and nutrition disorders   
Decreased appetite  1  28/144 (19.44%) 
Hyperuricaemia  1  18/144 (12.50%) 
Hyponatraemia  1  11/144 (7.64%) 
Hypokalaemia  1  9/144 (6.25%) 
Hyperglycaemia  1  8/144 (5.56%) 
Hypomagnesaemia  1  8/144 (5.56%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  41/144 (28.47%) 
Muscle spasms  1  28/144 (19.44%) 
Back pain  1  23/144 (15.97%) 
Myalgia  1  17/144 (11.81%) 
Pain in extremity  1  15/144 (10.42%) 
Musculoskeletal pain  1  8/144 (5.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma  1  13/144 (9.03%) 
Nervous system disorders   
Headache  1  18/144 (12.50%) 
Dizziness  1  14/144 (9.72%) 
Peripheral sensory neuropathy  1  12/144 (8.33%) 
Psychiatric disorders   
Insomnia  1  12/144 (8.33%) 
Depression  1  10/144 (6.94%) 
Anxiety  1  8/144 (5.56%) 
Renal and urinary disorders   
Haematuria  1  9/144 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  46/144 (31.94%) 
Dyspnoea  1  18/144 (12.50%) 
Oropharyngeal pain  1  13/144 (9.03%) 
Epistaxis  1  12/144 (8.33%) 
Nasal congestion  1  10/144 (6.94%) 
Productive cough  1  10/144 (6.94%) 
Rhinorrhoea  1  8/144 (5.56%) 
Skin and subcutaneous tissue disorders   
Night sweats  1  23/144 (15.97%) 
Rash maculo-papular  1  13/144 (9.03%) 
Rash erythematous  1  12/144 (8.33%) 
Rash  1  11/144 (7.64%) 
Skin lesion  1  11/144 (7.64%) 
Pruritus  1  9/144 (6.25%) 
Vascular disorders   
Hypertension  1  39/144 (27.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Alvina Chu
Organization: Pharmacyclics, Inc.
Phone: 855-427-8846
EMail: medinfo@pcyc.com
Layout table for additonal information
Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT01744691    
Other Study ID Numbers: PCYC-1117-CA
2012-004476-19 ( EudraCT Number )
First Submitted: December 3, 2012
First Posted: December 7, 2012
Results First Submitted: May 21, 2015
Results First Posted: June 9, 2015
Last Update Posted: February 27, 2017