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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04342117
Recruitment Status : Terminated (Strategy Change)
First Posted : April 10, 2020
Last Update Posted : March 17, 2021
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Lymphoma, Small Lymphocytic Lymphoma Lymphoma, Non-Hodgkin Chronic Lymphocytic Leukemia Follicular Lymphoma 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
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
Actual Study Start Date : April 23, 2020
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Group/Cohort Intervention/treatment
Patients who take duvelisib.
Drug: duvelisib
25 mg BID, 15 mg BID
Other Name: Copiktra, VS-0145

Other PI3K-inhibitors
Patients who take a PI3K-inhibitor other than duvelisib
Drug: PI3K inhibitor
FDA approved PI3K inhibitors

Primary Outcome Measures :
  1. Event-Free Survival (EFS) [ Time Frame: 2 years ]
    Observe the effectiveness of the PI3K-inhibitor administered

Secondary Outcome Measures :
  1. Measurement of Quality of Life - EQ-5D [ Time Frame: 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.

  2. Measurement of Quality of Life - FACT-lym [ Time Frame: 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.

  3. Characterize patient characteristics initiating treatment with PI3K-inhibitors [ Time Frame: 2 years ]
    Patient demographics, medical and disease history, prior therapies, and dosing regimen

  4. Measure Time to Next Treatment (TTNT) [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04342117

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United States, Arkansas
CARTI Cancer Center
Little Rock, Arkansas, United States, 72205
United States, Illinois
Joliet Oncology-Hematology Associates, LTD
Joliet, Illinois, United States, 60435
United States, Indiana
Goshen General Hospital
Goshen, Indiana, United States, 46526
United States, Iowa
McFarland Clinic,PC
Ames, Iowa, United States, 50010
United States, Maryland
St. Agnes Hospital
Baltimore, Maryland, United States, 21229
Regional Cancer Care Associates LLC
Bethesda, Maryland, United States, 20817
United States, Mississippi
Hattiesburg Clinic, PA
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Capital Region Medical Center
Jefferson City, Missouri, United States, 65101
Oncology Hematology Associates
Springfield, Missouri, United States, 65807
United States, New York
NY Cancer and Blood Specialists
Port Jefferson Station, New York, United States, 11776
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
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Responsible Party: SecuraBio Identifier: NCT04342117    
Other Study ID Numbers: VS-0145-401
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021

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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
Additional relevant MeSH terms:
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Lymphoma, Follicular
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell