A Disease Registry of Patients With Mantle Cell Lymphoma (SUMMIT)

April 10, 2024 updated by: AstraZeneca

Treatment Patterns, Outcomes, and Patient-Reported Health-Related Quality of Life: A Prospective Disease Registry of Patients With Mantle Cell Lymphoma Treated With Novel Agents

The purpose of this study is to create a patient registry in order to assess treatment patterns, physician reported clinical outcomes and patient-reported health-related quality of life among patients diagnosed with Mantle Cell Lymphoma (MCL) who newly initiated a novel therapy in the past 6 months and whose treatment is ongoing at the time of enrollment.

Study Overview

Status

Completed

Conditions

Detailed Description

Newer targeted therapies (monotherapy or in combination with other agents) have been recently approved in the United States for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least 1 prior therapy. The approval of these newer therapies will have an impact on the treatment patterns, toxicity patterns, and outcomes in the MCL population. A prospective, observational study will help to better understand the evolving real-world treatment outcomes (including treatment patterns, reasons for discontinuation/dose reduction, treatment interruption or treatment switches), physician-reported clinical outcomes, and patient-reported symptoms and health-related quality of life (HRQoL) among patients diagnosed with Mantle Cell Lymphoma (MCL) who newly initiated a novel therapy in the past 6 months and whose treatment is ongoing at the time of enrollment.

Study Type

Observational

Enrollment (Actual)

229

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36101
        • Research Site
    • California
      • Clovis, California, United States, 93611
        • Research Site
    • Colorado
      • Boulder, Colorado, United States, 80303-1385
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Research Site
      • Pensacola, Florida, United States, 32503
        • Research Site
      • Tampa, Florida, United States, 33612-9497
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Research Site
      • Augusta, Georgia, United States, 30912
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Research Site
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Research Site
      • Saint Louis Park, Minnesota, United States, 55416
        • Research Site
      • Saint Paul, Minnesota, United States, 55102
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Research Site
    • New Jersey
      • Berkeley Heights, New Jersey, United States, 07922
        • Research Site
      • Hackensack, New Jersey, United States, 07601
        • Research Site
    • New York
      • East Syracuse, New York, United States, 13057
        • Research Site
      • New York, New York, United States, 10022
        • Research Site
    • Oregon
      • Eugene, Oregon, United States, 97401-8122
        • Research Site
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19111
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Research Site
      • Dallas, Texas, United States, 75231
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98122
        • Research Site
      • Seattle, Washington, United States, 98195-9472
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients with a diagnosis of MCL who have received any line of novel MCL treatment within the past 6 months (and treatment is ongoing at the time of enrollment).

Description

Inclusion Criteria:

  • Patient diagnosed with Mantle Cell Lymphoma (MCL)
  • Informed consent for participation
  • Age ≥ 18 years old, as of the first observed diagnosis of MCL

  • Patients for whom a clinical decision has been made to initiate novel therapy in the last 6 months, limited to the following novel agent categories:

    • Bcl-2 inhibitors
    • BTK inhibitors
    • Immunomodulatory agents
    • Phosphoinositide 3-kinase inhibitors The novel agent must have been granted approval in at least one haematological cancer. Treatment must be ongoing at the time of enrollment.

Exclusion Criteria:

• Patient is participating in a clinical study that prohibits participation in non-interventional studies, or where treatment is blinded, at the time of consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Single cohort (registry) of MCL patients
Patients diagnosed with MCL who have initiated a novel therapy meeting inclusion/exclusion criteria in the past 6 months and treatment is ongoing at the time of enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The frequency and proportion of patients exposed to each novel agent therapy
Time Frame: 24 to 60 months
MCL novel agent treatment types are part of the primary study objective relating to treatment patterns and will be descriptive only and use aggregated patient data.
24 to 60 months
The frequency and proportion of patients exposed to novel agent by therapy regimen
Time Frame: 24 to 60 months
MCL treatment regimens are part of the primary study objective relating to treatment patterns and will be descriptive only and use aggregated patient data.
24 to 60 months
The frequency and proportion of patients exposed to novel agent by line of therapy
Time Frame: 24 to 60 months
MCL treatment line is part of the primary study objective relating to treatment patterns and will be descriptive only and use aggregated patient data.
24 to 60 months
The frequency and proportion of patients exposed to novel agent by therapy class
Time Frame: 24 to 60 months.
MCL treatment class is part of the primary study objective relating to treatment patterns and will be descriptive only and use aggregated patient data.
24 to 60 months.
The rate of patients who change novel agent therapy dose (in months)
Time Frame: 24 to 60 months.
Summarizing MCL novel agent treatment dose changes are part of the primary study objective relating to treatment patterns and will be descriptive only. Time-to-dose change will be assessed. The rate of dose modification (in months) will be estimated using aggregated patient data. Summary statistics (mean, SD, median, IQR, minimum, and maximum) will be used to describe time on a particular dose, which will be measured from the start of treatment until the date of dose change or death.
24 to 60 months.
The rate of patients who interrupt novel agent therapy (in months)
Time Frame: 24 to 60 months
Summarizing MCL treatment interruptions are part of the primary study objective relating to treatment patterns and will be descriptive only. The rate of treatment interruption (in months) will be estimated using aggregated patient data. Summary statistics (mean, SD, median, IQR, minimum, and maximum) will be used to describe time on therapy, which will be measured from the start of treatment until the date of interruption or death.
24 to 60 months
The rate of patients who discontinue novel agent therapy (in months)
Time Frame: 24 to 60 months
Summarizing MCL treatment discontinuations are part of the primary study objective relating to treatment patterns and will be descriptive only. The rate of treatment discontinuation (in months) will be estimated using aggregated patient data. Reasons for discontinuations will be collected and summarized categorically. Summary statistics (mean, SD, median, IQR, minimum, and maximum) will be used to describe time on therapy, which will be measured from the start of treatment until the date of discontinuation or death.
24 to 60 months
The duration of MCL treatment
Time Frame: 24 to 60 months
Summarizing MCL treatment duration is part of the primary study objective relating to treatment patterns and will be descriptive only. The duration and number of cycles of each targeted treatment (mean, SD, median, IQR, minimum, and maximum) will be summarized. Summary statistics (mean, SD, median, IQR, minimum, and maximum) will be used to describe time on therapy (in months), which will be measured from the start of treatment until the date of discontinuation, interruption, switch or death.
24 to 60 months
Estimate the overall response rate (ORR) among patients diagnosed with MCL and initiating treatment with novel therapies
Time Frame: 24 to 60 months.
ORR will be measured as the frequency and proportion of patients with a complete or partial response based on physician assessment during the observation period.
24 to 60 months.
Estimate the complete response rate (CR) among patients diagnosed with MCL and initiating treatment with novel therapies.
Time Frame: 24 to 60 months.
The CR will be calculated as the frequency and proportion of patients with a complete response based on physician assessment during the observation period.
24 to 60 months.
Estimate progression-free survival (PFS) among patients diagnosed with MCL and initiating treatment with novel therapies.
Time Frame: 24 to 60 months
All survival outcome measures will be descriptive only. PFS will be calculated as the time from the start of novel MCL treatment until progression or death. Summary statistics (mean, median, SD, IQR, minimum and maximum) will be used to describe PFS. Kaplan-Meier curves will be used to graphically show PFS.
24 to 60 months
Estimate event-free survival (EFS) among patients diagnosed with MCL and initiating treatment with novel therapies.
Time Frame: 24 to 60 months
All survival outcome measures will be descriptive only. EFS will be calculated as the time from the start of novel MCL treatment to disease progression, death, or discontinuation of treatment for any reason (eg, toxicity, patient preference, or initiation of a new treatment without documented progression).
24 to 60 months
Estimate overall survival (OS) among patients diagnosed with MCL and initiating treatment with novel therapies.
Time Frame: 24 to 60 months
All survival outcome measures will be descriptive only. OS will be captured using summary statistics (mean, SD, median, IQR, minimum and maximum), which will be used to describe time from diagnosis to death, time from enrollment to death, time from index novel MCL treatment to death and time from second treatment (if applicable) to death. Kaplan-Meier curves will be used to graphically show patient survival.
24 to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The frequency of adverse events (AEs) in patients with MCL, where the term AE is used to include both serious and non-serious AEs.
Time Frame: 24 to 60 months
The frequency of patients with AEs will be tabulated from the start of index novel MCL treatment. AEs (both in terms of the MedDRA Preferred Terms (PTs) and Common Terminology Criteria for Adverse Events [CTCAE] grade) will be listed individually by patient and described by System Organ Class (SOC) and PT.
24 to 60 months
The proportion of adverse events (AEs) in patients with MCL, where the term AE is used to include both serious and non-serious AEs.
Time Frame: 24 to 60 months
The proportion of patients with AEs will be calculated from the start of index novel MCL treatment. AEs (both in terms of the MedDRA Preferred Terms (PTs) and Common Terminology Criteria for Adverse Events [CTCAE] grade) will be listed individually by patient and described by System Organ Class (SOC) and PT.
24 to 60 months
Estimate the frequency of serious adverse events (SAEs) in patients with MCL
Time Frame: 24 to 60 months
The proportion and frequency patients with SAEs will be tabulated from the start of index novel MCL treatment.
24 to 60 months
Estimate the frequency of reported serious adverse safety events and adverse events leading to treatment changes associated with novel agents in patients with MCL
Time Frame: 24 to 60 months
The proportion and frequency of all SAEs and any AEs leading to treatment changes will be tabulated overall, and will also include the frequency and proportion of: (1) drug discontinuations, (2) dose interruptions or (3) dose changes.
24 to 60 months
Estimate the frequency and proportion of patients experiencing a clinical event of interest (related to MCL or MCL treatment)
Time Frame: 24 to 60 months
The clinical events of interest that have an economic impact will be tabulated with the frequency and proportion of patients experiencing the event. Medical interventions used for managing clinical events of interest including but not limited to: diagnostic tests, procedures and medications.
24 to 60 months
Estimate the frequency and proportion of patients experiencing healthcare resource utilization (HCRU), such as inpatient or emergency department visits
Time Frame: 24 to 60 months
Each type of physician visit will be tabulated at the aggregate level using the mean, SD, median, IQR, minimum and maximum. The total number of visits across all facilities will also be calculated.
24 to 60 months
Tabulate HRQoL responses for the validated EORTC QLC-C30 Patient Reported Outcome (PRO) in patients with MCL
Time Frame: 24 to 60 months
Descriptive statistics for each validated PRO will include continuous measures (mean, median, SD, IQR, minimum, and maximum) or achievement of a particular threshold (frequency and proportion), if applicable. This study will collect patient perceptions of HRQoL based on PRO measures in patients with MCL by collecting the European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) on a quarterly basis. The EORTC QLQ-C30 has a recall/observation period during the past week. The questionnaire uses a 4-point Likert scale ranging from 1: "Not at all" to 4: "Very much," and scores by dimension range from 0 to 100.
24 to 60 months
Tabulate HRQoL responses for the three selected, validated PRO-CTCAE PRO measures in patients with MCL
Time Frame: 24 to 60 months
Descriptive statistics for each validated PRO will include continuous measures (mean, median, SD, IQR, minimum, and maximum) or achievement of a particular threshold (frequency and proportion), if applicable. This study will collect patient perceptions of HRQoL by collecting the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) (3 questions regarding muscle pain, joint pain, heart palpitations) on a quarterly basis. The PRO-CTCAE is intended for individuals 18 years or older and has a recall of the past 7 days. Responses to each question are scored from 0 to 4 (in order of increasing frequency and severity).
24 to 60 months
Tabulate HRQoL responses for the validated PRO EuroQoL 5-Dimension 5-Level (EQ-5D-5L) in patients with MCL
Time Frame: 24 to 60 months
Descriptive statistics for each validated PRO will include continuous measures (mean, median, SD, IQR, minimum, and maximum) or achievement of a particular threshold (frequency and proportion), if applicable. This study will collect patient perceptions of HRQoL based on PRO measures in patients with MCL by collecting the EQ-5D-5L on a quarterly basis. This questionnaire is comprised of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and 1 visual analog scale used to assess a patient's self-rated health. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A unique health state is defined by combining 1 level from each of the 5 dimensions. Each health state is referred to in terms of a 5-digit code.
24 to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Richard Hermann, Senior Medical Director, Haematology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

March 18, 2024

Study Completion (Actual)

March 18, 2024

Study Registration Dates

First Submitted

December 10, 2018

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 25, 2019

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8220R00004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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