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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lymphoma; Lymphoma, Non-Hodgkin; Follicular Lymphoma; Chronic Lymphocytic Leukemia; Lymphoma, Small Lymphocytic
• Intervention / Treatment: Drug: duvelisib; Drug: PI3K inhibitor

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.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • CARTI Cancer Center
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Joliet Oncology-Hematology Associates, LTD
  • Indiana
    • Goshen, Indiana, United States, 46526
      • Goshen General Hospital
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic,PC
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • St. Agnes Hospital
    • Bethesda, Maryland, United States, 20817
      • Regional Cancer Care Associates LLC
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic, PA
  • Missouri
    • Jefferson City, Missouri, United States, 65101
      • Capital Region Medical Center
    • Springfield, Missouri, United States, 65807
      • Oncology Hematology Associates
  • New York
    • Port Jefferson Station, New York, United States, 11776
      • NY Cancer and Blood Specialists
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Approximately 200 patients with a clinical or pathological diagnosis of CLL/SLL or pathological diagnosis of FL, for whom the Investigator has decided PI3K-inhibitor treatment is the appropriate therapy will be enrolled

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Duvelisib; Patients who take duvelisib.	Drug: duvelisib; 25 mg BID, 15 mg BID; Other Names: Copiktra, VS-0145
Other PI3K-inhibitors; Patients who take a PI3K-inhibitor other than duvelisib	Drug: PI3K inhibitor; FDA approved PI3K inhibitors

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SecuraBio

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, B-Cell; Lymphoma; Lymphoma, Follicular; Leukemia; Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: VS-0145-401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No