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

SecuraBio2 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

duvelisibDRUG

25 mg BID, 15 mg BID

PI3K inhibitorDRUG

FDA approved PI3K inhibitors

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

CARTI Cancer Center

Little Rock, Arkansas, United States

Joliet Oncology-Hematology Associates, LTD

Joliet, Illinois, United States

Goshen General Hospital

Goshen, Indiana, United States

Outcomes

Primary Outcomes

Event-Free Survival (EFS)

Observe the effectiveness of the PI3K-inhibitor administered

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 2 years

Characterize patient characteristics initiating treatment with PI3K-inhibitors

Data from ClinicalTrials.gov

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