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
Trial record 1 of 1 for:    D8220R00004
Previous Study | Return to List | Next Study

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

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: NCT03816683
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date December 10, 2018
First Posted Date January 25, 2019
Last Update Posted Date July 8, 2020
Actual Study Start Date April 1, 2019
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 24, 2019)
  • 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.
  • The frequency and proportion of patients exposed to novel agent 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.
  • 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.
  • The frequency and proportion of patients exposed to novel agent 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 during the observation period.
  • 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.
  • 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).
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 24, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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).
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Disease Registry of Patients With Mantle Cell Lymphoma
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
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 3 months and treatment is ongoing at the time of enrollment.
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 MCL who newly initiated a novel therapy in the past 3 months, and treatment is ongoing at the time of enrollment
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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 3 months (and treatment is ongoing at the time of enrollment).
Condition Mantle Cell Lymphoma
Intervention Not Provided
Study Groups/Cohorts Single cohort (registry) of MCL patients
Patients diagnosed with MCL who have initiated a novel therapy meeting inclusion/exclusion criteria in the past 3 months and treatment is ongoing at the time of enrollment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 24, 2019)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2024
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Eligibility 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 3 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 enrolment.

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03816683
Other Study ID Numbers D8220R00004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators Not Provided
PRS Account AstraZeneca
Verification Date June 2020