Observational Trial of Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in CLL/SLL and FL

Study Overview
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Brief Summary
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This study will assess whether there are differences in effectiveness and safety outcomes among PI3K-treated patients in a real world registry, compared to patients treated in clinical trials.

Detailed Description
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Phase IV, multicenter, prospective observational study in a real world (RW) setting, designed to observe the utilization and effectiveness of PI3K-inhibitor treatment, and HRQoL of patients with CLL/SLL/FL outside the context of a clinical trial.

Official Title
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PI3K-Inhibitor Registry Study: Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma

Conditions
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Lymphoma, Small Lymphocytic, Lymphoma, Lymphoma, Non-Hodgkin, Chronic Lymphocytic Leukemia, Follicular Lymphoma

Intervention / Treatment
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* Drug: duvelisib
* Drug: PI3K inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical or pathological diagnosis of CLL/SLL according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) diagnosis guideline or pathological diagnosis of FL, for whom the Investigator has decided that PI3K-inhibitor treatment is the appropriate therapy Patients previously treated with PI3K-inhibitors are eligible for this study if they: Are restarting treatment with PI3K-inhibitor at enrollment, or Restarted PI3K-inhibitor treatment within 3 treatment cycles prior to enrollment Patients newly treated with PI3K-inhibitors are eligible for this study if they: Are starting treatment with PI3K-inhibitors at enrollment, or Started on PI3K-inhibitor treatment within 3 treatment cycles prior to enrollment ≥18 years of age at time consent is provided to participate in this study For patients treated with PI3K-inhibitors prior to enrollment in the study, availability of documentation of previous PI3K-inhibitor treatment, including the start date of previous or current PI3K-inhibitor treatment in patient charts or medical records Patient is willing and able to provide a signed and dated Institutional Review Board (IRB)-approved informed consent form (ICF) Exclusion Criteria: Not applicable

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 |
| --- | --- |
| Duvelisib<br>Patients who take duvelisib. | Drug: duvelisib<br>* 25 mg BID, 15 mg BID<br>* Other names: Copiktra, VS-0145;|
| Other PI3K-inhibitors<br>Patients who take a PI3K-inhibitor other than duvelisib | Drug: PI3K inhibitor<br>* FDA approved PI3K inhibitors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-Free Survival (EFS) | Observe the effectiveness of the PI3K-inhibitor administered | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Quality of Life - EQ-5D | EQ-5D is a widely used health status instrument, which developed by the EuroQol Group in the 1980s. It provides a concise and generic measure to compare and value health status across disease areas. The 5-level EQ-5D-5L was introduced in 2009 to improve the sensitivity of the instrument and reduce the ceiling effect. The EQ-5D-5L consists of the descriptive system measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and the EQ visual analogue scale (VAS). The patient is asked to indicate his/her health state by choosing one of the 5 levels for each dimension: no problem, slight problems, moderate problems, severe problems and extreme problems. Each dimension has a 1-digit number that expresses the level selected for that dimension. The digit for the 5 dimensions will be combined into a 5-digit number that describes a patient's health profile. Results of the EQ VAS will be presented to measure overall self-rated health status. | 2 years | 
| Measurement of Quality of Life - FACT-lym | The Functional Assessment of Cancer Therapy - Lymphoma (FACT-lym) is a PRO measure used to assess HRQoL in patients undergoing cancer therapy. The instrument includes 27 questions on the impacts of cancer therapy over the past 7 days in four domains plus 15 questions related to lymphoma patients: physical, social/family, emotional, and functional over the past 7 days. Each question is answered using a 5-point Likert scale ranging from 0 (not at all) to 4 (very much), where higher numbers indicate better health state. Scores of each domain will be calculated by adding scores for questions included in each domain, and a total score for the FACT-Lym will be obtained by adding each of the subscale scores, with higher score indicating better health state. | 2 years | 
| Characterize patient characteristics initiating treatment with PI3K-inhibitors | Patient demographics, medical and disease history, prior therapies, and dosing regimen | 2 years | 
| Measure Time to Next Treatment (TTNT) | The length of time from the date the patient initiates PI3K-inhibitor treatment to the date of initiating the next line of therapy. | 2 years |