Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342117
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Verastem, Inc.

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023


Group/Cohort Intervention/treatment
Duvelisib
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.


Layout table for eligibility information
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT04342117


Contacts
Layout table for location contacts
Contact: Emile Youssef 1-781-292-4200 eyoussef@verastem.com

Locations
Layout table for location information
United States, Arkansas
CARTI Cancer Center Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Cristal Montgomery    501-906-4198    cristal.montgomery@carti.com   
United States, Illinois
Joliet Oncology-Hematology Associates, LTD Recruiting
Joliet, Illinois, United States, 60435
Contact: Joan Pufahl    815-730-3098    joanp@jolietoncology.com   
United States, Indiana
Goshen General Hospital Recruiting
Goshen, Indiana, United States, 46526
Contact: Stephen Glick    574-364-2893    sglick@goshenhealth.com   
United States, Iowa
McFarland Clinic,PC Recruiting
Ames, Iowa, United States, 50010
Contact: Sheri Gatchehl    515-239-2684    gatchel@mgmc.com   
United States, Maryland
St. Agnes Hospital Recruiting
Baltimore, Maryland, United States, 21229
Contact: Elizabeth Chandler    667-234-2966    echandle@ascension.org   
Regional Cancer Care Associates LLC Recruiting
Bethesda, Maryland, United States, 20817
Contact: Natalie Bongiorno    240-482-0526    nbongiorno@regionalcancercare.org   
United States, Mississippi
Hattiesburg Clinic, PA Recruiting
Hattiesburg, Mississippi, United States, 39401
Contact: Tammy McBeth    601-288-2495    tmcbeth@forrestgeneral.com   
United States, Missouri
Capital Region Medical Center Recruiting
Jefferson City, Missouri, United States, 65101
Contact: Amy Franken    573-893-2375    amy5c@socket.net   
Oncology Hematology Associates Recruiting
Springfield, Missouri, United States, 65807
Contact: Adrianna Moore    417-822-4880    Adrianna.moore@aoncology.com   
United States, New York
NY Cancer and Blood Specialists Recruiting
Port Jefferson Station, New York, United States, 11776
Contact: Laura Brady    631-675-5146    lbrady@nycancer.com   
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Jennifer Burken    608-262-1671    burkenbrett@wisc.edu   
Sponsors and Collaborators
Verastem, Inc.
Layout table for additonal information
Responsible Party: Verastem, Inc.
ClinicalTrials.gov Identifier: NCT04342117    
Other Study ID Numbers: VS-0145-401
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

Layout table for additional information
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:
Layout table for MeSH terms
Lymphoma
Leukemia
Lymphoma, Follicular
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell