The study is designed as a multicenter, prospective, observational registry of CLL/SLL patients who are initiating approved oral kinase inhibitors, BCL-2 inhibitors or other approved anti-CLL therapies/regimens. The study will characterize treatment patterns and their association with patient characteristics, healthcare resource utilization, and clinical outcomes, as well as patient-reported outcome (PRO) measures.
This multicenter, prospective, observational registry of CLL patients is designed to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors and other approved anti-CLL therapies/ regimens. The registry will provide information on regimens used to treat first-line and later lines of CLL as well as the sequencing of treatment regimens. The registry will also evaluate the association of these treatment patterns with patient characteristics, healthcare resource utilization, and functional outcomes including patient-reported HRQoL. These data will provide information to physicians that may help guide clinical practice and appropriate use of therapies, and will also provide information on HRQoL and healthcare resource utilization that will be of interest to healthcare decision makers.
Study Type
OBSERVATIONAL
Enrollment
1,504
Summarize baseline characteristics of study population, among CLL patients in a real-world setting
\- Summarize baseline characteristics of study participants
Time frame: up to 7 years
Summarize treatment patterns among CLL patients in a real-world setting
* Summarize number of participants on various initial and subsequent treatments * Summarize proportion of patients switching therapies at each follow up time point
Time frame: up to 7 years
Summarize clinical outcomes among CLL patients in a real-world setting
\- Measures of effectiveness used will include survival status, ECOG Health status, response assessments as evaluated by the investigator such as: complete response, partial response, stable disease, progressive disease
Time frame: up to 7 years
Summarize health care resource utilization among CLL patients in a real-world setting
\- Summarize health care resource utilization among study participants
Time frame: up to 7 years
Summarize non serious adverse events (AEs) that led to discontinuation/modification/interruption of therapy and all serious adverse events in CLL patients
\- Summarize frequencies and percentages of AEs, that led to discontinuation/modification/interruption of therapy or death in CLL patients
Time frame: up to 7 years
Summarize patient-reported HRQoL scores
\- Summarize HRQoL scores as measured by FACT-G and additional questions from other PRO instruments at baseline and each follow-up
Time frame: up to 7 years
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