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

• ClinicalTrials.gov Identifier: NCT03816683
• Recruitment Status: Active, not recruiting
• First Posted: January 25, 2019
• Last Update Posted: February 13, 2023
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Study Description

Brief Summary:

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.

Condition or disease
Mantle Cell Lymphoma

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 Design

• Study Type: Observational
• Actual Enrollment: 231 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Actual Study Start Date: April 1, 2019
• Estimated Primary Completion Date: June 30, 2024
• Estimated Study Completion Date: June 30, 2024

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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).
13. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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).
9. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 130 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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).

Criteria

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.

Contacts and Locations

Locations

United States, Alabama

Research Site

Montgomery, Alabama, United States, 36101

United States, California

Research Site

Clovis, California, United States, 93611

United States, Colorado

Research Site

Boulder, Colorado, United States, 80303-1385

United States, Florida

Research Site

Jacksonville, Florida, United States, 32256

Research Site

Pensacola, Florida, United States, 32503

Research Site

Tampa, Florida, United States, 33612-9497

United States, Georgia

Research Site

Atlanta, Georgia, United States, 30322

Research Site

Augusta, Georgia, United States, 30912

United States, Illinois

Research Site

Chicago, Illinois, United States, 60612

United States, Iowa

Research Site

Iowa City, Iowa, United States, 52242

United States, Maryland

Research Site

Rockville, Maryland, United States, 20852

United States, Michigan

Research Site

Ann Arbor, Michigan, United States, 48109

United States, Minnesota

Research Site

Duluth, Minnesota, United States, 55805

Research Site

Saint Louis Park, Minnesota, United States, 55416

Research Site

Saint Paul, Minnesota, United States, 55102

United States, Nebraska

Research Site

Lincoln, Nebraska, United States, 68510

United States, New Jersey

Research Site

Berkeley Heights, New Jersey, United States, 07922

Research Site

Hackensack, New Jersey, United States, 07601

United States, New York

Research Site

East Syracuse, New York, United States, 13057

Research Site

New York, New York, United States, 10022

United States, Oregon

Research Site

Bend, Oregon, United States, 97701

Research Site

Eugene, Oregon, United States, 97401-8122

United States, Pennsylvania

Research Site

Philadelphia, Pennsylvania, United States, 19104

Research Site

Philadelphia, Pennsylvania, United States, 19111

United States, Tennessee

Research Site

Nashville, Tennessee, United States, 37232

United States, Texas

Research Site

Dallas, Texas, United States, 75231

Research Site

Dallas, Texas, United States, 75390

Research Site

Houston, Texas, United States, 77030

Research Site

Lubbock, Texas, United States, 79410

Research Site

San Antonio, Texas, United States, 78229

United States, Washington

Research Site

Seattle, Washington, United States, 98122

Research Site

Seattle, Washington, United States, 98195-9472

United States, West Virginia

Research Site

Morgantown, West Virginia, United States, 26506

United States, Wisconsin

Research Site

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

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• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT03816683
• Other Study ID Numbers: D8220R00004
• First Posted: January 25, 2019
• Last Update Posted: February 13, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

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.

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

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

• URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AstraZeneca:

Mantle Cell Lymphoma; Registry; MCL novel therapy; MCL treatment patterns; MCL reported outcomes

Additional relevant MeSH terms:

Lymphoma; Lymphoma, Mantle-Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin