Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
Sponsor
Pharmacyclics LLC. (Industry)
Overall Status
Completed
CT.gov ID
NCT01109069
Collaborator
Janssen Research & Development, LLC (Industry)
199
16
1
106.8
12.4
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the long-term safety of a fixed-dose, daily regimen of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
199 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
Study Start Date
:
Jun 1, 2010
Actual Primary Completion Date
:
Apr 26, 2019
Actual Study Completion Date
:
Apr 26, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PCI-32765
|
Drug: PCI-32765
Dose based on parent protocol
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With Adverse Events [30 days after last dose of study drug, continue up to 6 months]
Subjects were to receive ibrutinib once daily at the dose level the subject was receiving in the parent study until disease progression or unacceptable toxicity. The study included Screening, Treatment (from the first dose until study drug discontinuation), and Follow-up Phases.
Secondary Outcome Measures
- Progressive Disease (PD) [30 days after last dose of study drug, continue up to 6 months]
A progressive disease confirmed by a CT scan.
- Death Event [30 days after last dose of study drug]
All death events are due to AE, progressive disease, and other reasons.
- Documented Responses [30 days after last dose of study drug, continue up to 6 months]
Investigator-assessed responses were summarized descriptively for subjects with CLL/SLL and listed for subjects with other NHLs based on the efficacy population.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Men and women with recurrent surface immunoglobulin positive B cell non-Hodgkin's lymphoma (NHL) according to WHO classification (including, but not limited to, CLL/SLL, Waldenström's macroglobulinemia [WM], mantle cell lymphoma [MCL], and diffuse large B cell lymphoma [DLBCL) who have met requirements for roll over from their parent protocol and want to continue study drug.
-
Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose of study drug and agree to use dual methods of contraception during the study and for 1 month following the last dose with study drug. Post menopausal females (>45 years old and without menses for >1 year) and surgically sterilized females are exempt from this criterion.
-
Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential.
-
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
-
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
Exclusion Criteria:
-
A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
-
Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection.
-
Lactating or pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University | Stanford | California | United States | 94305 |
| 2 | Stanford | California | United States | 94305 | |
| 3 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 4 | Boston | Massachusetts | United States | 02215 | |
| 5 | New Hyde Park | New York | United States | 11042 | |
| 6 | New York | New York | United States | 10065 | |
| 7 | Rochester | New York | United States | 14642-0001 | |
| 8 | Columbus | Ohio | United States | 43210 | |
| 9 | Springfield | Oregon | United States | 97477 | |
| 10 | Nashville | Tennessee | United States | 37203 | |
| 11 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 12 | Houston | Texas | United States | 77030 | |
| 13 | Tyler | Texas | United States | 75702 | |
| 14 | Fletcher Allen Health Care and University of Vermont | Burlington | Vermont | United States | 05405 |
| 15 | Vancouver | Washington | United States | 98684 | |
| 16 | Yakima Valley Memorial Hospital/North Star Lodge | Yakima | Washington | United States | 98902 |
Sponsors and Collaborators
- Pharmacyclics LLC.
- Janssen Research & Development, LLC
Investigators
- Study Director: James Dean, MD, Medical Monitor
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT01109069
Other Study ID Numbers:
- PCYC-1103-CA
- PCI-32765
First Posted:
Apr 22, 2010
Last Update Posted:
May 27, 2020
Last Verified:
Mar 1, 2020
Keywords provided by Pharmacyclics LLC.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 27 July 2010 (the first Patient enrolled) to 31 March 2016 (the Last patient enrolled), Study was approved on June 2010. |
|---|---|
| Pre-assignment Detail | This study was open to subjects from prior ibrutinib studies who met eligibility criteria for rollover from their parent study and wanted to continue receiving study drug. |
| Arm/Group Title | A LONG-TERM SAFETY STUDY OF BRUTON'S TYROSINE KINASE (BTK) INH |
|---|---|
| Arm/Group Description | A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia. This is a multicenter(16 sites in the USA), open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. Ibrutinib was supplied as 140 mg or 40 mg capsules for oral administration. Subjects were to receive daily administration of a fixed dose of ibrutinib at the same dose level as in the parent study (up to 840 mg). |
| Period Title: Overall Study | |
| STARTED | 199 |
| COMPLETED | 106 |
| NOT COMPLETED | 93 |
Baseline Characteristics
| Arm/Group Title | A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inh |
|---|---|
| Arm/Group Description | A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia. This is a multicenter(16 sites in the USA), open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. Ibrutinib was supplied as 140 mg or 40 mg capsules for oral administration. Subjects were to receive daily administration of a fixed dose of ibrutinib at the same dose level as in the parent study (up to 840 mg). |
| Overall Participants | 199 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
83
41.7%
|
| >=65 years |
116
58.3%
|
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
65.6
(8.98)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
56
28.1%
|
| Male |
143
71.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
6
3%
|
| Not Hispanic or Latino |
192
96.5%
|
| Unknown or Not Reported |
1
0.5%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
1
0.5%
|
| Asian |
2
1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
8
4%
|
| White |
185
93%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
3
1.5%
|
| Region of Enrollment (participants) [Number] | |
| United States |
199
100%
|
| Estimated creatinine clearance rate (mL/min) (ML/min) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [ML/min] |
85.55
(34.150)
|
Outcome Measures
| Title | Number of Subjects With Adverse Events |
|---|---|
| Description | Subjects were to receive ibrutinib once daily at the dose level the subject was receiving in the parent study until disease progression or unacceptable toxicity. The study included Screening, Treatment (from the first dose until study drug discontinuation), and Follow-up Phases. |
| Time Frame | 30 days after last dose of study drug, continue up to 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | A LONG-TERM SAFETY STUDY OF BRUTON'S TYROSINE KINASE (BTK) INH |
|---|---|
| Arm/Group Description | A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia. This is a multicenter(16 sites in the USA), open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. Ibrutinib was supplied as 140 mg or 40 mg capsules for oral administration. Subjects were to receive daily administration of a fixed dose of ibrutinib at the same dose level as in the parent study (up to 840 mg). |
| Measure Participants | 199 |
| Count of Participants [Participants] |
199
100%
|
| Title | Progressive Disease (PD) |
|---|---|
| Description | A progressive disease confirmed by a CT scan. |
| Time Frame | 30 days after last dose of study drug, continue up to 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | IBRUTINIB/PCI-32765 |
|---|---|
| Arm/Group Description | This was a multicenter, open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. PCI-32765: Dose based on parent protocol CLL: chronic lymphocytic leukemia/ SLL: small lymphocytic lymphoma. |
| Measure Participants | 199 |
| Count of Participants [Participants] |
70
35.2%
|
| Title | Death Event |
|---|---|
| Description | All death events are due to AE, progressive disease, and other reasons. |
| Time Frame | 30 days after last dose of study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | IBRUTINIB/PCI-32765 |
|---|---|
| Arm/Group Description | This was a multicenter, open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. PCI-32765: Dose based on parent protocol CLL: chronic lymphocytic leukemia/ SLL: small lymphocytic lymphoma. |
| Measure Participants | 199 |
| Count of Participants [Participants] |
42
21.1%
|
| Title | Documented Responses |
|---|---|
| Description | Investigator-assessed responses were summarized descriptively for subjects with CLL/SLL and listed for subjects with other NHLs based on the efficacy population. |
| Time Frame | 30 days after last dose of study drug, continue up to 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | IBRUTINIB/PCI-32765 |
|---|---|
| Arm/Group Description | This was a multicenter, open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. PCI-32765: Dose based on parent protocol CLL: chronic lymphocytic leukemia/ SLL: small lymphocytic lymphoma. |
| Measure Participants | 199 |
| CLL/SLL |
180
90.5%
|
| Other NHL |
16
8%
|
| Treatment discontinuation |
3
1.5%
|
Adverse Events
| Time Frame | 8 Years, 5 months. This is a safety longterm follow-up study, it doesn't have any common milestones. | |
|---|---|---|
| Adverse Event Reporting Description | Adverse event data collection included Grade 3 or 4 AEs and major hemorrhage AEs, and the following: Grade 2 or higher eye-related AEs, and AEs of any grade that were serious, an +other malignancy, or led to dose reduction or treatment discontinuation. | |
| Arm/Group Title | IBRUTINIB/PCI-32765 | |
| Arm/Group Description | This was a multicenter, open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. PCI-32765: Dose based on parent protocol CLL: chronic lymphocytic leukemia/ SLL: small lymphocytic lymphoma. | |
All Cause Mortality |
||
| IBRUTINIB/PCI-32765 | ||
| Affected / at Risk (%) | # Events | |
| Total | 111/199 (55.8%) | |
Serious Adverse Events |
||
| IBRUTINIB/PCI-32765 | ||
| Affected / at Risk (%) | # Events | |
| Total | 111/199 (55.8%) | |
| Blood and lymphatic system disorders | ||
| Febrile neutropenia | 4/199 (2%) | 5 |
| Anaemia | 1/199 (0.5%) | 1 |
| Neutropenia | 1/199 (0.5%) | 1 |
| Cardiac disorders | ||
| Atrial fibrillation | 21/199 (10.6%) | 25 |
| Angina pectoris | 2/199 (1%) | 2 |
| Atrial flutter | 2/199 (1%) | 2 |
| Sinus bradycardia | 2/199 (1%) | 2 |
| Arteriosclerosis coronary artery | 1/199 (0.5%) | 1 |
| Atrioventricular block complete | 1/199 (0.5%) | 1 |
| Bundle branch block left | 1/199 (0.5%) | 1 |
| Bundle branch block right | 1/199 (0.5%) | 1 |
| Cardiac failure congestive | 1/199 (0.5%) | 1 |
| Cardio-respiratory arrest | 1/199 (0.5%) | 1 |
| Coronary artery disease | 1/199 (0.5%) | 1 |
| Ischaemic cardiomyopathy | 1/199 (0.5%) | 1 |
| Myocardial infarction | 1/199 (0.5%) | 1 |
| Palpitations | 1/199 (0.5%) | 1 |
| Pericarditis | 1/199 (0.5%) | 1 |
| Subendocardial ischaemia | 1/199 (0.5%) | 1 |
| Ventricular tachycardia | 1/199 (0.5%) | 2 |
| Ear and labyrinth disorders | ||
| Haematotympanum | 1/199 (0.5%) | 1 |
| Eye disorders | ||
| Uveitis | 1/199 (0.5%) | 1 |
| Gastrointestinal disorders | ||
| Diarrhoea | 3/199 (1.5%) | 3 |
| Abdominal pain upper | 2/199 (1%) | 2 |
| Gastrointestinal haemorrhage | 2/199 (1%) | 2 |
| Upper gastrointestinal haemorrhage | 2/199 (1%) | 2 |
| Dysphagia | 1/199 (0.5%) | 1 |
| Enteritis | 1/199 (0.5%) | 1 |
| Nausea | 1/199 (0.5%) | 1 |
| Oesophageal ulcer | 1/199 (0.5%) | 1 |
| Pancreatitis necrotising | 1/199 (0.5%) | 1 |
| Small intestinal obstruction | 1/199 (0.5%) | 1 |
| Umbilical hernia | 1/199 (0.5%) | 1 |
| Vomiting | 1/199 (0.5%) | 1 |
| General disorders | ||
| Pyrexia | 8/199 (4%) | 9 |
| Asthenia | 1/199 (0.5%) | 1 |
| Chest pain | 1/199 (0.5%) | 1 |
| Fatigue | 1/199 (0.5%) | 1 |
| Multiple organ dysfunction syndrome | 1/199 (0.5%) | 1 |
| Hepatobiliary disorders | ||
| Cholecystitis | 2/199 (1%) | 2 |
| Cholecystitis acute | 1/199 (0.5%) | 1 |
| Infections and infestations | ||
| Pneumonia | 32/199 (16.1%) | 61 |
| Cellulitis | 13/199 (6.5%) | 16 |
| Sepsis | 11/199 (5.5%) | 12 |
| Urinary tract infection | 6/199 (3%) | 7 |
| Gastroenteritis | 3/199 (1.5%) | 4 |
| Gastroenteritis viral | 3/199 (1.5%) | 4 |
| Herpes zoster | 3/199 (1.5%) | 3 |
| Septic shock | 3/199 (1.5%) | 3 |
| Bacteraemia | 2/199 (1%) | 2 |
| Clostridium difficile colitis | 2/199 (1%) | 2 |
| Diverticulitis | 2/199 (1%) | 3 |
| Gastroenteritis clostridial | 2/199 (1%) | 2 |
| Influenza | 2/199 (1%) | 3 |
| Localised infection | 2/199 (1%) | 2 |
| Lung infection | 2/199 (1%) | 3 |
| Urosepsis | 2/199 (1%) | 2 |
| Viral infection | 2/199 (1%) | 2 |
| Acute sinusitis | 1/199 (0.5%) | 1 |
| Appendicitis | 1/199 (0.5%) | 1 |
| Bronchitis | 1/199 (0.5%) | 1 |
| Bronchopulmonary aspergillosis | 1/199 (0.5%) | 1 |
| Cellulitis orbital | 1/199 (0.5%) | 1 |
| Cellulitis staphylococcal | 1/199 (0.5%) | 1 |
| Clostridial sepsis | 1/199 (0.5%) | 1 |
| Clostridium difficile infection | 1/199 (0.5%) | 1 |
| Dengue fever | 1/199 (0.5%) | 1 |
| Ear infection | 1/199 (0.5%) | 1 |
| Fusarium infection | 1/199 (0.5%) | 3 |
| Gangrene | 1/199 (0.5%) | 1 |
| Gastrointestinal infection | 1/199 (0.5%) | 1 |
| Klebsiella infection | 1/199 (0.5%) | 1 |
| Klebsiella sepsis | 1/199 (0.5%) | 1 |
| Lymphangitis | 1/199 (0.5%) | 1 |
| Osteomyelitis | 1/199 (0.5%) | 1 |
| Parainfluenzae virus infection | 1/199 (0.5%) | 1 |
| Pelvic abscess | 1/199 (0.5%) | 1 |
| Pharyngitis | 1/199 (0.5%) | 1 |
| Pilonidal cyst | 1/199 (0.5%) | 1 |
| Pneumonia bacterial | 1/199 (0.5%) | 1 |
| Pneumonia fungal | 1/199 (0.5%) | 1 |
| Pneumonia legionella | 1/199 (0.5%) | 1 |
| Pneumonia pseudomonal | 1/199 (0.5%) | 1 |
| Pneumonia respiratory syncytial viral | 1/199 (0.5%) | 1 |
| Pseudomonal bacteraemia | 1/199 (0.5%) | 1 |
| Pseudomonas infection | 1/199 (0.5%) | 1 |
| Pyelonephritis | 1/199 (0.5%) | 1 |
| Sinusitis | 1/199 (0.5%) | 1 |
| Staphylococcal infection | 1/199 (0.5%) | 1 |
| Vestibular neuronitis | 1/199 (0.5%) | 1 |
| Wound infection | 1/199 (0.5%) | 1 |
| Wound infection staphylococcal | 1/199 (0.5%) | 1 |
| Injury, poisoning and procedural complications | ||
| Subdural haematoma | 3/199 (1.5%) | 4 |
| Fall | 2/199 (1%) | 2 |
| Femoral neck fracture | 1/199 (0.5%) | 1 |
| Hip fracture | 1/199 (0.5%) | 1 |
| Perirenal haematoma | 1/199 (0.5%) | 1 |
| Splenic rupture | 1/199 (0.5%) | 1 |
| Subarachnoid haemorrhage | 1/199 (0.5%) | 1 |
| Thermal burn | 1/199 (0.5%) | 1 |
| Investigations | ||
| Transaminases increased | 1/199 (0.5%) | 1 |
| Metabolism and nutrition disorders | ||
| Hypercalcaemia | 2/199 (1%) | 2 |
| Decreased appetite | 1/199 (0.5%) | 1 |
| Dehydration | 1/199 (0.5%) | 1 |
| Diabetic ketosis | 1/199 (0.5%) | 1 |
| Failure to thrive | 1/199 (0.5%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Osteoarthritis | 2/199 (1%) | 2 |
| Lumbar spinal stenosis | 1/199 (0.5%) | 1 |
| Musculoskeletal chest pain | 1/199 (0.5%) | 1 |
| Pain in extremity | 1/199 (0.5%) | 1 |
| Spinal column stenosis | 1/199 (0.5%) | 1 |
| Spondylolisthesis | 1/199 (0.5%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Chronic lymphocytic leukaemia | 3/199 (1.5%) | 4 |
| Lung adenocarcinoma | 3/199 (1.5%) | 3 |
| Richter's syndrome | 3/199 (1.5%) | 4 |
| Bladder neoplasm | 2/199 (1%) | 2 |
| Adenocarcinoma | 1/199 (0.5%) | 1 |
| Appendix cancer | 1/199 (0.5%) | 1 |
| Basal cell carcinoma | 1/199 (0.5%) | 1 |
| Bladder transitional cell carcinoma | 1/199 (0.5%) | 1 |
| Chronic lymphocytic leukaemia transformation | 1/199 (0.5%) | 1 |
| Colon cancer | 1/199 (0.5%) | 1 |
| Invasive ductal breast carcinoma | 1/199 (0.5%) | 1 |
| Lung adenocarcinoma recurrent | 1/199 (0.5%) | 1 |
| Malignant melanoma | 1/199 (0.5%) | 1 |
| Mantle cell lymphoma | 1/199 (0.5%) | 1 |
| Metastases to central nervous system | 1/199 (0.5%) | 1 |
| Metastases to lung | 1/199 (0.5%) | 1 |
| Myelodysplastic syndrome | 1/199 (0.5%) | 1 |
| Nasopharyngeal cancer | 1/199 (0.5%) | 1 |
| Neuroendocrine carcinoma of the skin | 1/199 (0.5%) | 1 |
| Ovarian cancer | 1/199 (0.5%) | 1 |
| Ovarian cancer metastatic | 1/199 (0.5%) | 1 |
| Prostate cancer | 1/199 (0.5%) | 1 |
| Renal cell carcinoma | 1/199 (0.5%) | 1 |
| Nervous system disorders | ||
| Syncope | 3/199 (1.5%) | 3 |
| Headache | 2/199 (1%) | 2 |
| Transient ischaemic attack | 2/199 (1%) | 2 |
| Autoimmune neuropathy | 1/199 (0.5%) | 1 |
| Cauda equina syndrome | 1/199 (0.5%) | 1 |
| Dizziness | 1/199 (0.5%) | 1 |
| Embolic stroke | 1/199 (0.5%) | 1 |
| Encephalopathy | 1/199 (0.5%) | 1 |
| Hypoaesthesia | 1/199 (0.5%) | 1 |
| Ischaemic stroke | 1/199 (0.5%) | 1 |
| Myelitis transverse | 1/199 (0.5%) | 1 |
| Optic neuritis | 1/199 (0.5%) | 1 |
| Psychiatric disorders | ||
| Mental status changes | 3/199 (1.5%) | 3 |
| Confusional state | 1/199 (0.5%) | 1 |
| Renal and urinary disorders | ||
| Acute kidney injury | 4/199 (2%) | 4 |
| Haematuria | 1/199 (0.5%) | 1 |
| Ureterolithiasis | 1/199 (0.5%) | 1 |
| Urinary retention | 1/199 (0.5%) | 1 |
| Reproductive system and breast disorders | ||
| Prostatic obstruction | 1/199 (0.5%) | 1 |
| Prostatitis | 1/199 (0.5%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspnoea | 4/199 (2%) | 5 |
| Pleural effusion | 4/199 (2%) | 5 |
| Acute respiratory failure | 1/199 (0.5%) | 1 |
| Atelectasis | 1/199 (0.5%) | 1 |
| Hypoxia | 1/199 (0.5%) | 1 |
| Pulmonary alveolar haemorrhage | 1/199 (0.5%) | 1 |
| Respiratory failure | 1/199 (0.5%) | 2 |
| Tachypnoea | 1/199 (0.5%) | 1 |
| Tracheal stenosis | 1/199 (0.5%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Eosinophilic pustular folliculitis | 1/199 (0.5%) | 1 |
| Vascular disorders | ||
| Hypotension | 3/199 (1.5%) | 4 |
| Aortic aneurysm | 1/199 (0.5%) | 1 |
| Aortic stenosis | 1/199 (0.5%) | 1 |
| Deep vein thrombosis | 1/199 (0.5%) | 1 |
| Hypertension | 1/199 (0.5%) | 1 |
| Orthostatic hypotension | 1/199 (0.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| IBRUTINIB/PCI-32765 | ||
| Affected / at Risk (%) | # Events | |
| Total | 114/199 (57.3%) | |
| Blood and lymphatic system disorders | ||
| Neutropenia | 21/199 (10.6%) | 24 |
| Thrombocytopenia | 10/199 (5%) | 23 |
| Ear and labyrinth disorders | ||
| Cataract | 14/199 (7%) | 20 |
| Gastrointestinal disorders | ||
| Diarrohea | 9/199 (4.5%) | 10 |
| Infections and infestations | ||
| Upper Respiratory Track Infection | 9/199 (4.5%) | 10 |
| Investigations | ||
| Lymphocyte count decreased | 24/199 (12.1%) | 59 |
| Neutrophil Count decreased | 17/199 (8.5%) | 32 |
| White Blood cell count decreased | 8/199 (4%) | 12 |
| Metabolism and nutrition disorders | ||
| Hyperglycemia | 10/199 (5%) | 15 |
| Vascular disorders | ||
| Hypertension | 67/199 (33.7%) | 197 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Institution/Investigator will not publish without Sponsor prior review and approval Institution/Investigator will not publish until the earlier of (i) results of the study are submitted for publication (ii) notification that submission of the multicenter results is no longer planned (iii) 18 months after study termination.
Results Point of Contact
| Name/Title | James Dean |
|---|---|
| Organization | Pharmacyclics |
| Phone | 669-224-1880 |
| jdean@pcyc.com |
Responsible Party:
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT01109069
Other Study ID Numbers:
- PCYC-1103-CA
- PCI-32765
First Posted:
Apr 22, 2010
Last Update Posted:
May 27, 2020
Last Verified:
Mar 1, 2020