informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia

Conditions
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Chronic Lymphocytic Leukemia (CLL)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of at least 18 years Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008) Initiating anti-CLL/SLL treatment regimen (excluding clinical trials) within ±45 days of enrollment Availability of documentation of previous CLL/SLL treatment and duration of response in the patient's medical records if patient has received prior line(s) of treatment (i.e. NOT treatment naïve) Willing and able to provide informed consent Willing and able to complete PRO instrument Willing and able to provide information on patient survey questionnaire Willing and able to provide a blood sample at time of enrollment prior to receiving treatment, as possible Exclusion Criteria: Diagnosis of B-cell malignancies other than CLL/SLL Estimated life expectancy <6 months Currently receiving treatment in an interventional clinical trial at time of entry into this study * Note- Exceptions: 1) Patients may enroll in interventional clinical trials for indications other than CLL/SLL, 2) The interventional clinical trial treatment is not the treatment used for meeting Inclusion Criteria #2 (or Index Treatment), 3) Patients may enroll in an interventional clinical trial indicated for CLL/SLL as later line of treatment after discontinuing the Index Treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with CLL/SLL<br>Patients with CLL/SLL in a real-world setting initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other approved anti-CLL therapies/regimens. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summarize baseline characteristics of study population, among CLL patients in a real-world setting | - Summarize baseline characteristics of study participants | 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 | 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 | 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 | up to 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | up to 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Lymphocytic Leukemia, CLL, Small Lymphocytic Leukemia, SLL