Observational Trial of Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in CLL/SLL and FL
- Conditions
- Lymphoma, Small LymphocyticLymphomaLymphoma, Non-HodgkinChronic Lymphocytic LeukemiaFollicular Lymphoma
- Interventions
- Drug: PI3K inhibitor
- Registration Number
- NCT04342117
- Lead Sponsor
- SecuraBio
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
-
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)
- Not applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Other PI3K-inhibitors PI3K inhibitor Patients who take a PI3K-inhibitor other than duvelisib Duvelisib duvelisib Patients who take duvelisib.
- Primary Outcome Measures
Name Time Method Event-Free Survival (EFS) 2 years Observe the effectiveness of the PI3K-inhibitor administered
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (11)
CARTI Cancer Center
🇺🇸Little Rock, Arkansas, United States
Joliet Oncology-Hematology Associates, LTD
🇺🇸Joliet, Illinois, United States
McFarland Clinic,PC
🇺🇸Ames, Iowa, United States
Goshen General Hospital
🇺🇸Goshen, Indiana, United States
Hattiesburg Clinic, PA
🇺🇸Hattiesburg, Mississippi, United States
St. Agnes Hospital
🇺🇸Baltimore, Maryland, United States
NY Cancer and Blood Specialists
🇺🇸Port Jefferson Station, New York, United States
Oncology Hematology Associates
🇺🇸Springfield, Missouri, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Capital Region Medical Center
🇺🇸Jefferson City, Missouri, United States
Regional Cancer Care Associates LLC
🇺🇸Bethesda, Maryland, United States