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This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with Follicular Lymphoma (FL).
This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with FL.
There are two study treatment arms.
Subjects enrolled into main study treatment arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment.
Subjects enrolled into the exploratory study treatment arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main Study Arm 1 | Experimental | Subjects enrolled into this arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment. |
|
| Exploratory Study Arm 2 | Experimental | Subjects enrolled into this arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrutinib | Drug | All subjects will receive 560 mg of Ibrutinib orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR): Proportion of Subjects Achieving the Best Overall Responses of Complete Response (CR) or Partial Response (PR) | Number of subjects achieving the best overall responses of CR or PR prior to the initiation of the next line of antineoplastic therapy as assessed by investigator per the Cheson et al, 2007 criteria. Target lesions are measured by CT, unless MRI is used as the assessment modality for lesions in anatomical locations not amenable to CT. CR is defined as the disappearance of all evidence of disease. PR is defined as >=50% decrease in the sum of the product of the diameters of up to 6 largest dominant masses. | Subjects in Arm 1 will have imaging assessments every 12 weeks for the first 8 assessments, then every 24 weeks. Subjects in Arm 2 will have imaging assessments starting at week 9, then every 12 weeks for 8 assessments, then every 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR is defined as the interval between the date of the first documented response (CR, PR) and the date of the first documented evidence of progressive disease (PD) or death. DOR will be analyzed for the subjects who achieve an overall response during the duration of study. | Up to 45 months |
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Key Inclusion criteria:
Key Exclusion criteria:
Medically apparent central nervous system lymphoma or leptomeningeal disease
FL with evidence of large cell transformation
Any prior history of other hematologic malignancy besides FL or myelodysplasia
History of other malignancies, except
Currently active, clinically significant cardiovascular disease or myocardial infarction within 6 months of screening
Known anaphylaxis or Immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab (Rituxan®)
Requires anti-coagulation with warfarin or a vitamin K antagonist.
Requires treatment with strong cytochrome P450 (CYP) 3A inhibitors.
Known bleeding diathesis or hemophilia
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| Name | Affiliation | Role |
|---|---|---|
| Jutta K. Neuenburg, MD, PhD | Pharmacyclics LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Saint Joseph Medical Center | Burbank | California | 91505 | United States | ||
| City of Hope |
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| ID | Title | Description |
|---|---|---|
| FG000 | Main Study Arm 1 | Subjects enrolled into this arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment. Ibrutinib: All subjects will receive 560 mg of Ibrutinib orally. rituximab: All subjects will receive rituximab 375 mg/m2 intravenously |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2016 | Oct 24, 2018 |
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| rituximab | Drug | All subjects will receive rituximab 375 mg/m2 intravenously |
|
|
| Progression Free Survival (PFS) |
PFS is defined as the time interval between the date of the first dose and the date of the earliest occurrence of PD or death due to any cause, whichever occurs first. PD is characterized by any new lesion or increase by >=50% of previously involved sites from nadir. |
| Up to 45 months |
| Overall Survival (OS) | Subjects will be followed for survival information up to three years after the last dose of study treatment, until new treatment or death, whichever occurs first. OS is defined as the duration of time from the date of the first dose to the date of death from any cause. | Up to 45 months |
| Number of Participants With Treatment-emergent Adverse Events | Frequency, severity, and relatedness of treatment-emergent adverse events (AEs) Frequency of treatment-emergent AEs requiring discontinuation of study drug or dose reductions | Up to 45 months |
| Duarte |
| California |
| 91010 |
| United States |
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| Stanford University, Stanford Care Center | Stanford | California | 94305 | United States |
| Southeastern Regional Medical Center | Newnan | Georgia | 30265 | United States |
| Community Health Network Community Regional Cancer Center North | Indianapolis | Indiana | 46256 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89074 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Weill Cornell Medical College New York-Presbyterian Hospital | New York | New York | 10065 | United States |
| Mid-Ohio Oncology/ Hematology Inc | Columbus | Ohio | 43219 | United States |
| Tennessee Oncology, PLLC The Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| FG001 | Exploratory Study Arm 2 | Subjects enrolled into this arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity. Ibrutinib: All subjects will receive 560 mg of Ibrutinib orally. rituximab: All subjects will receive rituximab 375 mg/m2 intravenously |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Main Study Arm 1 | Subjects enrolled into this arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment. Ibrutinib: All subjects will receive 560 mg of Ibrutinib orally. rituximab: All subjects will receive rituximab 375 mg/m2 intravenously |
| BG001 | Exploratory Study Arm 2 | Subjects enrolled into this arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity. Ibrutinib: All subjects will receive 560 mg of Ibrutinib orally. rituximab: All subjects will receive rituximab 375 mg/m2 intravenously |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Baseline B-Symptoms | Criteria used to assess B-symptoms- Subject presenting with at least one of the following: Weight loss of >10% for the last 6 months or less; Fever >38C (100.4F) for at least 3 consecutive days within the last 3 months; Drenching night sweats within the last 3 months | Count of Participants | Participants |
| |||||||||||||||||
| Baseline Eastern Cooperative Oncology Group (ECOG) Score | ECOG Performance status = 0 Fully active, able to carry on all predisease performance without restriction. ECOG Performance status = 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light housework, office work. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR): Proportion of Subjects Achieving the Best Overall Responses of Complete Response (CR) or Partial Response (PR) | Number of subjects achieving the best overall responses of CR or PR prior to the initiation of the next line of antineoplastic therapy as assessed by investigator per the Cheson et al, 2007 criteria. Target lesions are measured by CT, unless MRI is used as the assessment modality for lesions in anatomical locations not amenable to CT. CR is defined as the disappearance of all evidence of disease. PR is defined as >=50% decrease in the sum of the product of the diameters of up to 6 largest dominant masses. | Posted | Count of Participants | Participants | Subjects in Arm 1 will have imaging assessments every 12 weeks for the first 8 assessments, then every 24 weeks. Subjects in Arm 2 will have imaging assessments starting at week 9, then every 12 weeks for 8 assessments, then every 24 weeks. |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR is defined as the interval between the date of the first documented response (CR, PR) and the date of the first documented evidence of progressive disease (PD) or death. DOR will be analyzed for the subjects who achieve an overall response during the duration of study. | Posted | Median | 95% Confidence Interval | months | Up to 45 months |
| |||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS is defined as the time interval between the date of the first dose and the date of the earliest occurrence of PD or death due to any cause, whichever occurs first. PD is characterized by any new lesion or increase by >=50% of previously involved sites from nadir. | Posted | Median | 95% Confidence Interval | months | Up to 45 months |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Subjects will be followed for survival information up to three years after the last dose of study treatment, until new treatment or death, whichever occurs first. OS is defined as the duration of time from the date of the first dose to the date of death from any cause. | Posted | Median | 95% Confidence Interval | months | Up to 45 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events | Frequency, severity, and relatedness of treatment-emergent adverse events (AEs) Frequency of treatment-emergent AEs requiring discontinuation of study drug or dose reductions | Posted | Count of Participants | Participants | Up to 45 months |
|
|
3 years, 9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Main Study Arm 1 | Subjects enrolled into this arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment. Ibrutinib: All subjects will receive 560 mg of Ibrutinib orally. rituximab: All subjects will receive rituximab 375 mg/m2 intravenously | 4 | 60 | 14 | 60 | 60 | 60 |
| EG001 | Exploratory Study Arm 2 | Subjects enrolled into this arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity. Ibrutinib: All subjects will receive 560 mg of Ibrutinib orally. rituximab: All subjects will receive rituximab 375 mg/m2 intravenously | 0 | 20 | 6 | 20 | 20 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Fallopian tube cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cerebral artery stenosis | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vascular encephalopathy | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cardiac flutter | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gilbert's syndrome | Congenital, familial and genetic disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Conductive deafness | Ear and labyrinth disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chapped lips | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Barrett's oesophagus | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Lip discolouration | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Lip ulceration | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Swelling | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Unevaluable event | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dacryocanaliculitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Prostate infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Polydipsia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dyspareunia | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vulvovaginal erythema | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vulvovaginal pain | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Eczema nummular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Koilonychia | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Scab | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jutta Neuenburg | Pharmacyclics | 408-215-3735 | jneuenburg@pcyc.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2017 | Oct 24, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C551803 | ibrutinib |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| B-Symptoms absent |
|
| Baseline ECOG Score = 1 |
|
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