HO-14-14607 - OBSERVATIONAL STUDY TO EXPLORE THE SAFETY, COSTS AND HEALTH CARE RESOURCE UTILIZATION, ASSOCIATED WITH FIRST LINE ARZERRA (OFATUMUMAB) OR GAZYVA (OBINUTUZUMAB) THERAPIES IN PATIENTS WITH UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) IN REAL WORLD SETTING

Trial description: This is an observational study that involves both prospective and retrospective elements. All data collection occurs retrospectively from data that was collected as part of routine clinical care in community oncology practices. The prospective element is ongoing, periodic review of the data to assess of the uptake of ofatumumab and obinutuzumab, and accrual of patients with a record of treatment with ofatumumab and obinutuzumab in the first line chronic lymphocytic leukemia (CLL) setting. The term “accrual” in this study refers to the identification of eligible patients and the decision to include them in the study. Accrual will be stratified to provide approximately 50% (plus or minus 3%) of the study sample in the ofatumumab and obinutuzumab treatment groups. The design is therefore a serial retrospective chart review.A review cycle will be initiated approximately every 6 months until the accrual targets for analysis of cost and of safety endpoints are reached. Within each review cycle, the study databases will be queried to identify patients with CLL who have initiated treatment with either ofatumumab or obinutuzumab. Eligible patients will be identified and accrued, and baseline study data collected.Data for each patient will be collected on two case report forms (CRF). The first will collect baseline demographic and clinical information, and document the regimen initiated as first line therapy. The second will retrospectively collect follow-up data from initiation of the ofatumumab- or obinutuzumab-containing regimen through the end of first line therapy. Consequently, the baseline and follow-up CRFs will overlap only to the extent of indicating the initial regimen and starting date of that regimen. The purpose of having a separate baseline CRF is to be able to readily examine the clinical and demographic characteristics of the patients that have been accrued in the study at interim time points, including at the planned interim analysis at accrual of the 150th patient. The follow-up CRF will have a safety section that will cover collection of safety endpoints through the end of first line therapy. The balance of the follow-up CRF will cover all other aspects of follow-up, including actual treatments delivered, as well as HRU and cost-related endpoints. New accruals and completion of follow-up CRFs will occur serially. The first analysis of the data will be a blinded safety review to assess the risk of grade 3 and 4 infusion reactions among the total study sample. For the first 100 patients accrued, the safety section of the follow-up CRF will be scheduled to be completed after patients have completed one month of first line therapy. This will permit early, blinded, evaluation of the risk of grade 3 and 4 infusion reaction. The balance of the CRFs for these first 100 patients will be completed on schedule with other follow-up CRFs, after patients have completed first line therapy. The complete follow-up CRF, including both cost and safety endpoints, will be completed for the first 200 patients accrued, even if these are not the first 200 patients to complete first line therapy. The reason is that collection of data on the first 200 to complete first line therapy would bias selection of cases for this endpoint toward those who have shorter duration of first line therapy. For patients accrued after the first 200, a more limited follow-up CRF that assesses only safety endpoints will be completed.The review cycle will repeat until the follow-up CRFs for all study patients are complete. The follow-up data collection for the 200 patients for whom cost and safety data are collected is expected to be complete before follow-up assessment for the additional 100 patients for whom safety endpoints only are collected. Because the cost and safety assessment follows patients over the course of first line therapy only, it is expected that there will be minimal censoring of data for cost or HRU analysis in the study.At each data collection point, data collection is retrospective, and will employ existing data that was collected as part of routine clinical care in community oncology practices. Data to be utilized for this study are data that have been aggregated by Vector Oncology into the Vector Oncology Data Warehouse, and data that resides within practices that are part of a network available to Vector Oncology through a large community oncology EMR vendor. No data will be collected prospectively, and there will be no contact with patients as part of this study. ARZERRA is a registered trademark of the GlaxoSmithKline group of companies.Gazyva is a registered trademark of Hoffmann-La Roche AG in the EU and Genentech, Inc. in the US.