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

Lymphoma Clinical Trial

— REAL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04342117
• Other study ID #: VS-0145-401
• Status: Terminated
• Start date: April 23, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: SecuraBio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Follicular Lymphoma
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin
• Lymphoma, Small Lymphocytic

Intervention

Drug:
• duvelisib
25 mg BID, 15 mg BID
• PI3K inhibitor
FDA approved PI3K inhibitors

Locations

Country	Name	City	State
United States	McFarland Clinic,PC	Ames	Iowa
United States	St. Agnes Hospital	Baltimore	Maryland
United States	Regional Cancer Care Associates LLC	Bethesda	Maryland
United States	Goshen General Hospital	Goshen	Indiana
United States	Hattiesburg Clinic, PA	Hattiesburg	Mississippi
United States	Capital Region Medical Center	Jefferson City	Missouri
United States	Joliet Oncology-Hematology Associates, LTD	Joliet	Illinois
United States	CARTI Cancer Center	Little Rock	Arkansas
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	NY Cancer and Blood Specialists	Port Jefferson Station	New York
United States	Oncology Hematology Associates	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
SecuraBio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-Free Survival (EFS)	Observe the effectiveness of the PI3K-inhibitor administered	2 years
Secondary	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
Secondary	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
Secondary	Characterize patient characteristics initiating treatment with PI3K-inhibitors	Patient demographics, medical and disease history, prior therapies, and dosing regimen	2 years
Secondary	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