Chronic Lymphocytic Leukemia, Follicular Lymphoma, Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Small Lymphocytic
Conditions
Brief summary
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
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.
Interventions
DRUGduvelisib
25 mg BID, 15 mg BID
DRUGPI3K inhibitor
FDA approved PI3K inhibitors
Sponsors
SecuraBio
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-Free Survival (EFS) | 2 years | Observe the effectiveness of the PI3K-inhibitor administered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Quality of Life - EQ-5D | 2 years | 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. |
| Measurement of Quality of Life - FACT-lym | 2 years | 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. |
| Characterize patient characteristics initiating treatment with PI3K-inhibitors | 2 years | Patient demographics, medical and disease history, prior therapies, and dosing regimen |
| Measure Time to Next Treatment (TTNT) | 2 years | The length of time from the date the patient initiates PI3K-inhibitor treatment to the date of initiating the next line of therapy. |
Countries
United States
Outcome results
None listed