protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT01578707 | 6.2 | Ibrutinib | 6.2. Ibrutinib | [] |
NCT01578707 | 6.2.1 | Dosage and Administration | 6.2.1. Dosage and Administration Ibrutinib 420 mg (3 x 140-mg capsules) is to be administered orally once daily with 8 ounces (approximately 240 mL) of water. The capsules should be swallowed intact and patients should not attempt to open capsules or dissolve them in water. Each dose of ibrutinib should be taken at app... | [] |
NCT01578707 | 6.2.2 | Dose Delay | 6.2.2. Dose Delay Treatment with ibrutinib should be held for any unmanageable, potentially study drug-related toxicity that is Grade 3 or higher in severity. Please se[e Section 6.6.1.4](#page-45-2) for guidelines for management of ibrutinib in patients who require anticoagulant treatment. Any other clinically importa... | [] |
NCT01578707 | 6.2.3 | Overdose | 6.2.3. Overdose Any dose of study drug administered in excess of that specified in this protocol is considered to be an overdose. Signs and symptoms of an overdose that meet any SAE criterion must be reported as a SAE in the appropriate time frame and documented as clinical sequelae to an overdose. There is no specific... | [] |
NCT01578707 | 6.2.4 | Dose Reduction and Discontinuation | 6.2.4. Dose Reduction and Discontinuation The actions in Table 2 should be taken for the following toxicities: - Grade 4 ANC ( 7 days (Neutrophil growth factors are permitted per ASCO guidelines [[Smith 2006](#page-94-2)] and use must be recorded in CRF). - Grade 3 or 4 platelets (daily) | | 3rd | Hold ibrutinib until ... | [] |
NCT01578707 | 6.2.5 | Treatment-related Lymphocytosis | 6.2.5. Treatment-related Lymphocytosis Treatment-related lymphocytosis, for the purposes of this protocol, is defined as an elevation in blood lymphocyte count of ≥50% compared to baseline that occurs in the setting of improvement in at least one other disease-related parameter and is associated with agents known to in... | [] |
NCT01578707 | 6.2.6 | Dose Modification for Hepatic Impaired Subjects | 6.2.6. Dose Modification for Hepatic Impaired Subjects Ibrutinib is metabolized in the liver and therefore subjects with clinically significant hepatic impairment at the time of screening (Child- Pugh class B or C) are excluded from study participation. For subjects who develop mild liver impairment while on study (Chi... | [] |
NCT01578707 | 6.2.7 | Precautions and Adverse Events | 6.2.7. Precautions and Adverse Events The most common treatment-emergent adverse events were diarrhea, fatigue, nausea, cough and anemia. Additional common AEs such as peripheral edema, pyrexia, vomiting, constipation, upper respiratory tract infection, arthralgia, dyspnea, thrombocytopenia, decreased appetite, headach... | [] |
NCT01578707 | 6.3 | Identification of Investigational Product(s) | 6.3. Identification of Investigational Product(s) | [] |
NCT01578707 | 6.3.1 | Ibrutinib | 6.3.1. Ibrutinib Ibrutinib is provided as hard gelatin capsules containing 140 mg of ibrutinib. The capsules are packaged in opaque high-density polyethylene (HDPE) plastic bottles with labels bearing the appropriate label text as required by governing regulatory agencies. The drug product is manufactured for Pharmacyc... | [] |
NCT01578707 | 6.3.2 | Ofatumumab | 6.3.2. Ofatumumab Ofatumumab, manufactured by GlaxoSmithKline, is provided in solution in single-use vials. Refer to the local ofatumumab package insert for details. | [] |
NCT01578707 | 6.4 | Treatment Compliance | 6.4. Treatment Compliance Patient compliance with ibrutinib will be assessed by the site pharmacist or designee at each visit using direct questioning, examination of patient diaries, and capsule counts. Ofatumumab compliance will be performed by the site pharmacist or designee as patients will not be taking the study ... | [] |
NCT01578707 | 6.5 | Randomization and Blinding | 6.5. Randomization and Blinding A minimum of 350 patients will be randomized in a 1:1 ratio to each of the 2 treatment arms in this study. Randomization will be used to minimize bias in the assignment of patients to the 2 treatment arms. Two randomization schemes will be generated: one for each geographic region (North... | [] |
NCT01578707 | 6.6 | Concomitant Therapy | 6.6. Concomitant Therapy | [] |
NCT01578707 | 6.6.1 | Concomitant Medications to be Used With Caution | 6.6.1. Concomitant Medications to be Used With Caution Antiemetics are permitted if clinically indicated. Standard supportive care medications are permitted; this includes pre-medication for ofatumumab infusion as per the ofatumumab package insert. Use of neutrophil growth factors (filgrastim and pegfilgrastim) is perm... | [
"For patients considered at risk for tumor lysis syndrome (TLS):"
] |
NCT01578707 | 6.6.1.1 | Guideline for Use of CYP Inhibiting/Inducing Drugs | 6.6.1.1. Guideline for Use of CYP Inhibiting/Inducing Drugs Ibrutinib is metabolized primarily by CYP3A4. Avoid co-administration with strong or moderate CYP3A inhibitors and consider alternative agents with less CYP3A inhibition. Co-administration of ketoconazole, a strong CYP3A inhibitor, in 18 healthy subjects incre... | [] |
NCT01578707 | 6.6.1.2 | Drugs That May Have Their Plasma Concentrations Altered by Ibrutinib | 6.6.1.2. Drugs That May Have Their Plasma Concentrations Altered by Ibrutinib In vitro studies indicated that ibrutinib is not a substrate of P-glycoprotein (P-gp), but is a mild inhibitor (with an IC50 of 2.15 μg/mL). Ibrutinib is not expected to have systemic drug-drug interactions with P-gp substrates. However, it c... | [] |
NCT01578707 | 6.6.1.3 | Concomitant Use of QT Prolonging Agents | 6.6.1.3. Concomitant Use of QT Prolonging Agents Any medications known to cause QT prolongation should be used with caution; periodic monitoring with electrocardiograms and electrolytes should be considered. | [] |
NCT01578707 | 6.6.1.4 | Concomitant Use of Antiplatelet Agents and Anticoagulants | 6.6.1.4. Concomitant Use of Antiplatelet Agents and Anticoagulants Warfarin or vitamin K antagonists should not be administered concomitantly with ibrutinib. Ibrutinib should be used with caution in patients requiring other anticoagulants or medications that inhibit platelet function. Supplements such as fish oil and v... | [] |
NCT01578707 | 6.6.2 | Prohibited Concomitant Medications | 6.6.2. Prohibited Concomitant Medications Any chemotherapy, anticancer immunotherapy, corticosteroids (at dosages equivalent to prednisone >20 mg/day), experimental therapy, or radiotherapy are prohibited. Localized, hormonal, or bone sparing treatment for non-B cell malignancies may be considered with approval of the ... | [] |
NCT01578707 | 6.6.3 | Guidelines for Ibrutinib Management with Surgeries or Procedures | 6.6.3. Guidelines for Ibrutinib Management with Surgeries or Procedures Ibrutinib may increase risk of bleeding with invasive procedures or surgery. The following guidance should be applied during the perioperative period for subjects who require surgical intervention or an invasive procedure while receiving ibrutinib:... | [] |
NCT01578707 | 7 | EFFICACY AND SAFETY PROCEDURES | 7. EFFICACY AND SAFETY PROCEDURES The Schedule of Assessments is provided in [Appendix A.](#page-96-0) Descriptions of the scheduled evaluations are outlined below. Product: IBRUTINIB (PCI-32765) Protocol PCYC-1112-CA 28 September 2016 IND # 102,688 Version: Amendment 7 Before study entry, throughout the study, and at ... | [] |
NCT01578707 | 7.1 | Description of Procedures | 7.1. Description of Procedures | [] |
NCT01578707 | 7.1.1 | Informed Consent | 7.1.1. Informed Consent The patient must read, understand, and sign the Institutional Review Board/Research Ethics Board/Independent Ethics Committee (IRB/REB/IEC)-approved informed consent form (ICF) confirming his or her willingness to participate in this study before any study-specific screening procedures are perfo... | [] |
NCT01578707 | 7.1.2 | Confirmation of Eligibility | 7.1.2. Confirmation of Eligibility Perform all necessary procedures and evaluations to document that the patient meets each eligibility criterion [\(Section 5\)](#page-33-0). Please refer to the study manual for a more detailed description of the enrollment procedures. Blood samples for hematology, coagulation, and ser... | [] |
NCT01578707 | 7.1.3 | Medical History | 7.1.3. Medical History Collect and record the patient's complete history including concurrent medical signs and symptoms. Disease history, including the date of initial diagnosis, Rai and Binet staging [\(Appendix I\)](#page-109-0) within 28 days of first dose with study drug, documentation of refractory disease, prior... | [] |
NCT01578707 | 7.1.4 | Adverse Events | 7.1.4. Adverse Events The accepted regulatory definition for an AE is provided in [Section 9.2.](#page-70-2) All medical occurrences that meet the AE definition must be recorded from the time the ICF is signed until 30 days after the last dose of study drug. Laboratory abnormalities designated clinically significant by... | [] |
NCT01578707 | 7.1.5 | Physical Examination, Height and Weight | 7.1.5. Physical Examination, Height and Weight Physical examinations should include height (Screening only) and weight, examination of the skin, eyes, ears, nose, throat, lungs, heart, abdomen, extremities, and lymphatic system. The lymphatic system examination will include bidimensional measurements of palpable lymph ... | [] |
NCT01578707 | 7.1.6 | Eye-related Symptoms Assessment | 7.1.6. Eye-related Symptoms Assessment The patients will be asked about the following eye-related symptoms at Screening and throughout the study: dry eye, watering eye/abnormal discharge, eye pain, blurred vision/double vision, decreased visual acuity, photophobia/sensitivity to light, floaters, flashing lights, and ey... | [] |
NCT01578707 | 7.1.7 | Disease-related Symptoms | 7.1.7. Disease-related Symptoms Disease-related symptoms including fatigue, night sweats, fever, weight loss, anorexia, and symptoms of splenomegaly (abdominal pain/discomfort) will be assessed and recorded in the patient records. | [] |
NCT01578707 | 7.1.8 | Vital Signs | 7.1.8. Vital Signs Vital signs will include blood pressure, heart rate, respiratory rate, and body temperature. | [] |
NCT01578707 | 7.1.9 | Electrocardiogram (ECG) | 7.1.9. Electrocardiogram (ECG) Patients should have a 12-lead ECG done at Screening. Abnormalities should be included in the medical history, as appropriate. ECGs should be performed at the investigator's discretion, particularly in patients with arrhythmic symptoms (eg, palpitations, lightheadedness) or new onset dysp... | [] |
NCT01578707 | 7.1.10 | ECOG Performance Status | 7.1.10. ECOG Performance Status The ECOG performance index is provided in [Appendix B.](#page-97-0) | [] |
NCT01578707 | 7.1.11 | Cumulative Illness Rating Scale (CIRS) | 7.1.11. Cumulative Illness Rating Scale (CIRS) CIRS is an indicator of illness severity and comorbidity in older patients [\(Extermann 1998\)](#page-92-0). CIRS scoring is to be performed by a licensed provider (eg, physician, physician assistant, or nurse) for all patients 65 years and older in the setting of a pretre... | [] |
NCT01578707 | 7.1.12 | Prior and Concomitant Medications | 7.1.12. Prior and Concomitant Medications Document all medications from 14 days before the start of study drug administration through 30 days after the last dose of study drug. After a patient discontinues study treatment, receipt of all subsequent anticancer therapies will be collected until patient death. | [] |
NCT01578707 | 7.1.13 | Patient-reported Outcomes (PRO) | 7.1.13. Patient-reported Outcomes (PRO) Three PRO instruments, including the EORTC QLQ-C30 [\(Appendix E\)](#page-100-0), EQ-5D-5L [\(Appendix F\)](#page-102-0), and FACiT-fatigue [\(Appendix G\)](#page-105-0), will be administered in this study. These questionnaires are to be completed by the patient prior to any othe... | [] |
NCT01578707 | 7.1.13.1 | EORTC QLQ-C30 | 7.1.13.1. EORTC QLQ-C30 The EORTC QLQ-C30 includes 30 separate questions (items) resulting in 5 functional scales (Physical Functioning, Role Functioning, Emotional Functioning, Cognitive Functioning, and Social Functioning), 1 Global Health Status scale, 3 symptom scales (Fatigue, Nausea and Vomiting, and Pain), and 6... | [] |
NCT01578707 | 7.1.13.2 | EQ-5D-5L | 7.1.13.2. EQ-5D-5L The EQ-5D-5L is a standardized instrument for use as a measure of health outcome (The [Euro Qol Group 1990\)](#page-92-0). The EQ-5D-5L is a 5-item questionnaire and a "thermometer" visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores ... | [] |
NCT01578707 | 7.1.13.3 | FACiT-Fatigue | 7.1.13.3. FACiT-Fatigue The FACiT-Fatigue questionnaire is an instrument for use as a measure of fatigue-related quality of life in patients with cancer and other chronic diseases (http://www.facit.org). The 13-item FACiT-Fatigue Scale measures each item on a 5‐point Likert scale. The FACiT-Fatigue Scale has been valid... | [] |
NCT01578707 | 7.1.14 | Pregnancy Test | 7.1.14. Pregnancy Test Pregnancy tests (urine or serum) are required at Screening only for women of childbearing potential. If positive, pregnancy must be ruled out by ultrasound to be eligible. This test may be performed more frequently if required by local regulatory authorities. | [] |
NCT01578707 | 7.1.15 | Hepatitis Serologies | 7.1.15. Hepatitis Serologies Hepatitis serologies include Hepatitis C antibody, Hepatitis B surface antigen, Hepatitis B surface antibody, and Hepatitis B core antibody and will be evaluated by central laboratory. Hepatitis B surface antigen must be confirmed negative prior to enrollment. If Hepatitis B core antibody i... | [] |
NCT01578707 | 7.1.16 | Hematology | 7.1.16. Hematology Hematology will be evaluated by a central laboratory and will include a complete blood count (CBC) with white blood cell differential. Any missing central lab blood samples should be redrawn as soon as possible. In the event that the missing central lab sample is unrecoverable, local lab results will... | [] |
NCT01578707 | 7.1.17 | Coagulation Studies | 7.1.17. Coagulation Studies Measurement of prothrombin time (PT)/INR, and activated partial thromboplastin time (aPTT) will be performed at Screening using a central laboratory. Any missing central lab blood samples should be redrawn as soon as possible. | [] |
NCT01578707 | 7.1.18 | Serum Chemistry | 7.1.18. Serum Chemistry Serum chemistry will be evaluated by a central laboratory and will include albumin, alkaline phosphatase, ALT, AST, blood urea nitrogen (BUN), calcium, creatinine, glucose, lactate dehydrogenase (LDH), phosphate, potassium, sodium, total bilirubin, and uric acid. Any missing central lab blood sa... | [] |
NCT01578707 | 7.1.19 | Serum Immunoglobulin and β2-microglobulin | 7.1.19. Serum Immunoglobulin and β2-microglobulin Sample(s) will be sent to a central laboratory for quantitative immunoglobulin (IgG, IgM, IgA) levels, and serum β2-microglobulin. | [] |
NCT01578707 | 7.1.20 | Sparse Pharmacokinetics (PK) Sample Collection | 7.1.20. Sparse Pharmacokinetics (PK) Sample Collection Sparse PK samples will be collected in patients randomized to ibrutinib. Samples will be collected from at least 100 patients. Five (5) blood samples will be collected per patient on the Week 1 Visit. - 1. Pre-dose - 2. 1 hour (window: 45–75 minutes) - 3. 2 hours (... | [] |
NCT01578707 | 7.1.21 | Pharmacokinetics Sample Collection for Patients Treated with Concomitant CYP3A4/5 Inhibitors on Ibrutinib Treatment | 7.1.21. Pharmacokinetics Sample Collection for Patients Treated with Concomitant CYP3A4/5 Inhibitors on Ibrutinib Treatment For patients who must take strong or moderate CYP3A4/5 inhibitors while on treatment with ibrutinib, additional PK collections for evaluation of ibrutinib exposure may be requested at the followin... | [] |
NCT01578707 | 7.1.22 | Bone Marrow Aspirate and Biopsy | 7.1.22. Bone Marrow Aspirate and Biopsy
For Eligibility A unilateral bone marrow aspirate or biopsy must be obtained at Screening or up to 90 days prior to randomization. Patients who have a bone marrow aspirate or biopsy result since completion of their last therapy for CLL may use those bone marrow results provided ... | [
"For Eligibility",
"For Response Evaluation"
] |
NCT01578707 | 7.1.23 | Cytogenetic CLL FISH Panel | 7.1.23. Cytogenetic CLL FISH Panel Cytogenetic profiles will use the standard CLL FISH probes to detect abnormalities in chromosomes 13q, 12, 11q, and 17p. Within 90 days prior to randomization, a peripheral blood sample or bone marrow sample (aspirate or biopsy) must be tested for FISH analysis for stratification purp... | [] |
NCT01578707 | 7.1.24 | Determination of T/B/NK Counts | 7.1.24. Determination of T/B/NK Counts In order to monitor the effects of ibrutinib on the immune cells in patients, specifically on the normal B cells, T cells and NK cells, whole blood samples will be analyzed for absolute T/B/NK IND # 102,688 Version: Amendment 7 counts (CD3, CD19, CD4, CD8, CD16/56) using a standar... | [] |
NCT01578707 | 7.1.25 | Flow Cytometry-based Immunophenotype Assays | 7.1.25. Flow Cytometry-based Immunophenotype Assays To determine the temporal effect of study drugs on the phenotype of malignant cells in patients, blood samples will be collected and analyzed centrally. Samples taken in the first 6 months will be more frequent in order to capture the treatment-effect of lymphocytosis... | [] |
NCT01578707 | 7.1.26 | Genetic and Molecular Prognostic Markers | 7.1.26. Genetic and Molecular Prognostic Markers A blood sample will be collected and analyzed centrally to study the pretreatment prognostic factors. These prognostic factors have previously been associated with disease outcome in CLL patients.
IgVH and p53 Mutational Status One sample will be collected to study leuk... | [
"IgVH and p53 Mutational Status",
"CD38 and ZAP-70 Leukemia Cell Expression"
] |
NCT01578707 | 7.1.27 | Exploratory Investigations of Predictive Biomarkers and Mechanism of Treatment Resistance | 7.1.27. Exploratory Investigations of Predictive Biomarkers and Mechanism of Treatment Resistance Additional blood samples will be collected and assessed or maintained centrally to evaluate potential biomarkers related to response to therapy and/or to investigate potential mechanisms of treatment resistance. These samp... | [] |
NCT01578707 | 7.1.28 | Computed Tomography (CT) Scans | 7.1.28. Computed Tomography (CT) Scans Radiological imaging by CT with contrast is required and must include the pelvis, abdomen, chest, and neck. Patients who are intolerant to IV CT contrast agents will have CT scans performed with oral contrast. When possible, all patients should have radiographic tumor measurements... | [] |
NCT01578707 | 7.1.29 | Medical Resources Utilization (MRU) | 7.1.29. Medical Resources Utilization (MRU) Hospitalizations, emergency department visits, blood product transfusions, and hematopoietic growth factor use will be collected for each treatment arm. | [] |
NCT01578707 | 7.1.30 | Routine Clinical Assessments | 7.1.30. Routine Clinical Assessments Routine clinical assessments include physical exams, recording of symptoms, and hematological evaluations to evaluate for both AEs and for disease progression at times when the CT scan is IND # 102,688 Version: Amendment 7 not obtained. If a patient shows signs of progression, the p... | [] |
NCT01578707 | 7.1.31 | Overall Response Evaluations | 7.1.31. Overall Response Evaluations Overall response assessments will include evaluation of physical exams, recording of symptoms, hematological evaluations, and radiographic evaluations per the schedule of assessments (see [Appendix A](#page-96-0) and [Appendix M\)](#page-113-0). Patients who have signs and symptoms ... | [] |
NCT01578707 | 7.1.32 | Survival | 7.1.32. Survival After progression, patients will be contacted to assess survival status approximately every 12 weeks until death, withdrawal by patient, lost to follow-up, or study terminated by Sponsor, whichever comes first. At the time of the interim analysis and at study closure, a survival sweep will be conducted... | [] |
NCT01578707 | 7.1.33 | Subsequent Anticancer Therapies | 7.1.33. Subsequent Anticancer Therapies After study drug treatment is complete, the following information on subsequent anticancer therapies will be collected approximately every 12 weeks until death, withdrawal by patient, lost to follow-up, or study terminated by Sponsor, whichever comes first: - Receipt of all subse... | [] |
NCT01578707 | 7.2 | Drug Concentration Measurements | 7.2. Drug Concentration Measurements | [] |
NCT01578707 | 7.2.1 | Sample Collection and Analysis | 7.2.1. Sample Collection and Analysis Sparse PK samples will be collected from at least 100 patients on the ibrutinib arm. Refer to the laboratory binder for instructions on collecting and processing these samples. Plasma samples will be analyzed by a validated and specific LC-MS/MS method for the determination of ibru... | [] |
NCT01578707 | 7.2.2 | Pharmacokinetic Assessment | 7.2.2. Pharmacokinetic Assessment Plasma concentrations, dosing history, demographic data, and other covariates will be assembled into a dataset suitable for a population PK analysis. The analysis will be performed using mixed-effects methods. Based on previous PK studies for ibrutinib, it is likely that the structural... | [] |
NCT01578707 | 7.3 | Assessments by Visit | 7.3. Assessments by Visit | [] |
NCT01578707 | 7.3.1 | Screening Phase | 7.3.1. Screening Phase The procedures below will be performed for potential patients within 28 days of Week 1 Visit: - Informed consent - Review of eligibility criteria - PRO assessments - Adverse events - Medical history - Physical examination - Eye-related symptoms - Vital signs - 12-lead ECG - ECOG performance statu... | [] |
NCT01578707 | 7.3.2 | Treatment Phase | 7.3.2. Treatment Phase Following completion of the Screening Visit and once eligibility has been confirmed, patients will be randomized to either ofatumumab or ibrutinib via an automatic IWRS or alternative system provided by the Sponsor. Randomization should occur as close to the time of the expected first dose as pos... | [] |
NCT01578707 | 7.3.2.1 | Pre-Dose Week 1 Visit | 7.3.2.1. Pre-Dose Week 1 Visit The following procedures will be performed prior to dosing (within 3 days) of the Week 1 Visit. Please note, Week 1 Visit procedures done at Screening will not need to be repeated if done within 3 days of first dose with study drug. - Confirmation of eligibility - Update medical history -... | [] |
NCT01578707 | 7.3.2.2 | Dose Week 1 Visit | 7.3.2.2. Dose Week 1 Visit • Administration of ofatumumab or ibrutinib | [] |
NCT01578707 | 7.3.2.3 | Post-Dose Week 1 Visit | 7.3.2.3. Post-Dose Week 1 Visit - Adverse events - Concomitant medications - Sparse PK sample at 1, 2, 4, and 6 hours (ibrutinib arm only) - MRU (no longer required per Amendment 5) | [] |
NCT01578707 | 7.3.2.4 | Week 2, 3, 5, 6, and 7 Visits | 7.3.2.4. Week 2, 3, 5, 6, and 7 Visits The following procedures will be performed, however, patients on the ibrutinib arm may have their blood drawn for the central lab submission at the site lab and do not need to return to clinic: - Administration of ofatumumab in clinic (ofatumumab arm only) - Hematology - Flow cyto... | [] |
NCT01578707 | 7.3.2.5 | Week 4-24 Visits, every 4 weeks | 7.3.2.5. Week 4-24 Visits, every 4 weeks The following procedures will be performed: - Administration of ofatumumab or ibrutinib - Physical examination - Eye-related symptoms (Weeks 12 and 24) - Disease-related symptoms (no longer required per Amendment 5) - Vital signs - ECOG performance status - PRO assessments - Con... | [] |
NCT01578707 | 7.3.2.6 | Weeks 36 until Discontinuation of Treatment, every 12 weeks | 7.3.2.6. Weeks 36 until Discontinuation of Treatment, every 12 weeks The following procedures will be performed: - Physical examination - Eye-related symptoms (every 12 weeks until 18 months, then once every 24 weeks) - Disease-related symptoms (no longer required per Amendment 5) - Vital signs - ECOG performance statu... | [] |
NCT01578707 | 7.3.2.7 | Response Evaluations, every 12 weeks from first dose until progression | 7.3.2.7. Response Evaluations, every 12 weeks from first dose until progression The following procedures will be performed in conjunction with standard visits every 12 weeks and then every 24 weeks after 18 months until the patient exhibits disease progression: - Radiologic exam by CT, only required every 24 weeks afte... | [] |
NCT01578707 | 7.3.2.8 | End-of-Treatment Visit | 7.3.2.8. End-of-Treatment Visit The following will be performed 30 (± 3) days after the discontinuation of treatment with study drug: - Physical examination - Vital signs - ECOG performance status - Eye-related symptoms - Disease-related symptoms (no longer required per Amendment 5) - PRO assessments - Concomitant medi... | [] |
NCT01578707 | 7.3.3 | Follow-up Phase | 7.3.3. Follow-up Phase | [] |
NCT01578707 | 7.3.3.1 | Post-treatment Phase | 7.3.3.1. Post-treatment Phase After discontinuation of treatment, the following assessments will be performed every 12 weeks (±7 days) until disease progression or study closure, whichever is earlier: - Subsequent anticancer therapies - Physical examination and ECOG performance status - Disease-related symptoms (no lon... | [] |
NCT01578707 | 7.3.3.2 | Post-disease Progression Phase | 7.3.3.2. Post-disease Progression Phase Once patient progresses, the following assessments will be assessed every 12 weeks until death, withdrawal by patient, lost to follow-up, or study terminated by Sponsor, whichever comes first. - Subsequent anticancer therapies - MRU (no longer required per Amendment 5) - Survival... | [] |
NCT01578707 | 7.3.4 | Treatment with Ibrutinib for Patients on Control Arm | 7.3.4. Treatment with Ibrutinib for Patients on Control Arm On 03 January 2014, the DMC determined that the primary endpoint of the study had been met and the analysis be considered final. Patients randomized to ofatumumab who meet the criteria outlined in Section 7.3.4.1, per the investigator's discretion, can receive... | [] |
NCT01578707 | 7.3.4.1 | Criteria for Next-line Ibrutinib Therapy | 7.3.4.1. Criteria for Next-line Ibrutinib Therapy - 1. Medical Monitor approval - 2. ECOG Performance Status of ≤3 ([Appendix B](#page-97-0)) - 3. Platelet count ≥25,000/μL - 4. No uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infe... | [] |
NCT01578707 | 7.3.4.2 | Next-line Ibrutinib Therapy Treatment Phase | 7.3.4.2. Next-line Ibrutinib Therapy Treatment Phase Refer to the next-line ibrutinib therapy Schedule of Assessments [\(Appendix M\)](#page-113-0) for a complete list of procedures to be performed at each scheduled study visit. | [] |
NCT01578707 | 8 | MAIN EFFICACY EVALUATIONS | 8. MAIN EFFICACY EVALUATIONS Disease evaluations will include: - Physical examination (which will focus on the presence or absence or increase or decrease in lymph nodes, liver, and spleen). - CBC with measurement of parameters by a central laboratory. - Computed tomography (CT) scan of the neck, chest, abdomen, and pe... | [] |
NCT01578707 | 8.1 | Definitions | 8.1. Definitions | [] |
NCT01578707 | 8.1.1 | Refractory | 8.1.1. Refractory Refractory is defined as treatment failure or progression within 12 months post-treatment. | [] |
NCT01578707 | 8.1.2 | Relapsed | 8.1.2. Relapsed Relapsed is defined as a patient who met criteria for CR or PR, but progressed beyond 12 months post-treatment. | [] |
NCT01578707 | 8.1.3 | Treatment Failure | 8.1.3. Treatment Failure Treatment failure is defined as best response of progressive disease or SD while on study treatment. | [] |
NCT01578707 | 8.1.4 | Measurable Disease | 8.1.4. Measurable Disease Patients must have at least 1 measurable site of disease to participate in this study. Measurable sites of disease are defined as lymph nodes, or lymph node masses. Each measurable site of IND # 102,688 Version: Amendment 7 disease must be greater than 1.5 cm in the longest diameter. Measureme... | [] |
NCT01578707 | 8.1.5 | Treatment-related Lymphocytosis | 8.1.5. Treatment-related Lymphocytosis Treatment-related lymphocytosis, for the purposes of this protocol, is defined as an elevation in blood lymphocyte count of ≥50% compared to baseline and ≥5000/µL that occurs in the setting of unequivocal improvement in at least one other disease-related parameter including lymph ... | [] |
NCT01578707 | 8.1.6 | Richter's Transformation | 8.1.6. Richter's Transformation Richter's syndrome (RS) is lymphomatous transformation to a more aggressive histology in a patient with CLL or SLL. RS is most often characterized by the development of high-grade NHL or Hodgkin's disease. Symptoms of Richter's transformation can include new or progressive lymphadenopath... | [] |
NCT01578707 | 8.1.7 | Minimal Residual Disease (MRD) | 8.1.7. Minimal Residual Disease (MRD) Patients who have achieved a CR should be evaluated for eradication of disease cells as determined by flow cytometry on the bone marrow aspiration when available. | [] |
NCT01578707 | 8.2 | Radiographic Images Assessment | 8.2. Radiographic Images Assessment Radiological efficacy assessments, for the purpose of the study result analyses, will be performed by the IRC, which will be blinded to study treatment information. The process and convention of the review will be detailed in a separate charter. The baseline disease assessment will i... | [] |
NCT01578707 | 8.3 | Guidelines for Evaluation | 8.3. Guidelines for Evaluation Table 3 outlines what is required for each parameter at baseline to be evaluable throughout the study. Table 3: Evaluable Parameter Requirements | Parameter | Requirements to be Evaluable for Response | |------------------------------------------------|------------------------------------... | [] |
NCT01578707 | 8.4 | Response Categories | 8.4. Response Categories Assessment of response should include physical examination, radiographic imaging, and evaluation of blood and marrow per the schedule of assessments (see [Appendix A](#page-96-0) and [Appendix M](#page-113-0)) and to confirm CR. Definition of response for CR, CRi, nPR, PR, PR with lymphocytosis... | [] |
NCT01578707 | 8.4.1 | Complete Response (CR) | 8.4.1. Complete Response (CR) All of the following are required for a CR: - No significant lymphadenopathy (>1.5cm) palpable on examination or by CT - No hepatosplenomegaly on examination or by CT • No constitutional symptoms (ie, no fever >38ºC for ≥2 weeks, no unintentional ≥10% body weight loss within last 6 months,... | [] |
NCT01578707 | 8.4.2 | Complete Response with an Incomplete Marrow Recovery (CRi) | 8.4.2. Complete Response with an Incomplete Marrow Recovery (CRi) CRi is defined as a CR with an incomplete recovery of the patient's bone marrow. Patients who have a CRi fulfill all criteria for a CR, but continue to have persistent anemia, thrombocytopenia, or neutropenia. These cytopenias are due to drug toxicity in... | [] |
NCT01578707 | 8.4.3 | Nodular Partial Response (nPR) | 8.4.3. Nodular Partial Response (nPR) nPR is a response where patients meet criteria for a CR, but the bone marrow biopsy shows that there are still B-lymphoid nodules, which may represent a clonal infiltrate. These nodules are residual disease and therefore the patient is termed an nPR. | [] |
NCT01578707 | 8.4.4 | Partial Response (PR) | 8.4.4. Partial Response (PR) A ≥50% drop in lymphocyte count from baseline or ≤4.0 x 109 /L is required for a PR and all of the following are observed: - ≥50% decrease in the sum products of up to 6 lymph nodes, a ≥50% decrease in the longest diameter of the single lymph node, or normalization of lymphadenopathy when c... | [] |
NCT01578707 | 8.4.5 | PR with Lymphocytosis | 8.4.5. PR with Lymphocytosis Patient achieved all PR criteria with the exception of lymphocyte criteria. | [] |
NCT01578707 | 8.4.6 | Stable Disease (SD) | 8.4.6. Stable Disease (SD) Not meeting criteria for CR, CRi, nPR, PR, PR with lymphocytosis, or progressive disease. | [] |
NCT01578707 | 8.4.7 | Progressive Disease | 8.4.7. Progressive Disease A CT scan is required to evaluate all cases of suspected progressive disease for this protocol regardless of the modality of disease progression (eg. lymph node, lymphocytosis, or transformation). Progressive disease requires at least ONE of following: - New enlarged nodes >1.5 cm, new hepato... | [] |
NCT01578707 | 8.5 | Sustained Hematological Improvement | 8.5. Sustained Hematological Improvement In the subset of patients with cytopenia(s) at baseline (Hgb ≤11g/dL, platelets ≤100,000/μL, or ANC ≤1500/μL), time to improvement in blood counts and percentage of patients with sustained improvement in blood counts, (sustained improvement, defined as improvement in cytopenia b... | [] |
NCT01578707 | 8.6 | Resolution of Pretreatment Disease-related Symptoms | 8.6. Resolution of Pretreatment Disease-related Symptoms Resolution of pretreatment symptoms including fatigue, weight loss, anorexia, fevers, night sweats, or symptoms of splenomegaly will be evaluated. | [] |
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