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Mantle Cell LymphomaSUMMITNCT03816683

A Disease Registry of Patients With Mantle Cell Lymphoma

An observational study of Mantle Cell Lymphoma, run by AstraZeneca at 32 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
Mantle Cell Lymphoma
How many people
227 participants
Where
32 sitesUnited States
Study dates
1 Apr 2019to 18 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

United States32 sites

  • Research Site

    Ann Arbor, Michigan, 48109

  • Research Site

    Atlanta, Georgia, 30322

  • Research Site

    Augusta, Georgia, 30912

  • Research Site

    Berkeley Heights, New Jersey, 07922

  • Research Site

    Boulder, Colorado, 80303-1385

  • Research Site

    Chicago, Illinois, 60612

  • Research Site

    Clovis, California, 93611

  • Research Site

    Dallas, Texas, 75231

  • Research Site

    Dallas, Texas, 75390

  • Research Site

    Danville, Pennsylvania, 17822

  • Research Site

    Duluth, Minnesota, 55805

  • Research Site

    East Syracuse, New York, 13057

  • Research Site

    Eugene, Oregon, 97401-8122

  • Research Site

    Hackensack, New Jersey, 07601

  • Research Site

    Houston, Texas, 77030

  • Research Site

    Iowa City, Iowa, 52242

  • Research Site

    Jacksonville, Florida, 32256

  • Research Site

    Lincoln, Nebraska, 68510

  • Research Site

    Milwaukee, Wisconsin, 53226

  • Research Site

    Montgomery, Alabama, 36101

  • Research Site

    Morgantown, West Virginia, 26506

  • Research Site

    Nashville, Tennessee, 37232

  • Research Site

    New York, New York, 10022

  • Research Site

    Pensacola, Florida, 32503

  • Research Site

    Philadelphia, Pennsylvania, 19104

  • Research Site

    Philadelphia, Pennsylvania, 19111

  • Research Site

    Saint Louis Park, Minnesota, 55416

  • Research Site

    Saint Paul, Minnesota, 55102

  • Research Site

    San Antonio, Texas, 78229

  • Research Site

    Seattle, Washington, 98122

  • Research Site

    Seattle, Washington, 98195-9472

  • Research Site

    Tampa, Florida, 33612-9497

Other trials in United States

About this study

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

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.

Read the 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.

Keywords
Mantle Cell Lymphoma, Registry, MCL novel therapy, MCL treatment patterns, MCL reported outcomes
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03816683
Study groupRoleWhat they receive
Single cohort (registry) of MCL patientsPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. The frequency and proportion of patients exposed to each novel agent therapy

    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.

    Measured: 24 to 60 months

  2. The frequency and proportion of patients exposed to novel agent by therapy regimen

    MCL treatment regimens are part of the primary study objective relating to treatment patterns and will be descriptive only and use aggregated patient data.

    Measured: 24 to 60 months

  3. The frequency and proportion of patients exposed to novel agent by line of therapy

    MCL treatment line is part of the primary study objective relating to treatment patterns and will be descriptive only and use aggregated patient data.

    Measured: 24 to 60 months

  4. The frequency and proportion of patients exposed to novel agent by therapy class

    MCL treatment class is part of the primary study objective relating to treatment patterns and will be descriptive only and use aggregated patient data.

    Measured: 24 to 60 months.

  5. The rate of patients who change novel agent therapy dose (in 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.

    Measured: 24 to 60 months.

  6. The rate of patients who interrupt novel agent therapy (in 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.

    Measured: 24 to 60 months

  7. The rate of patients who discontinue novel agent therapy (in 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.

    Measured: 24 to 60 months

  8. The duration of MCL treatment

    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.

    Measured: 24 to 60 months

  9. Estimate the overall response rate (ORR) among patients diagnosed with MCL and initiating treatment with novel therapies

    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.

    Measured: 24 to 60 months.

  10. Estimate the complete response rate (CR) among patients diagnosed with MCL and initiating treatment with novel therapies.

    The CR will be calculated as the frequency and proportion of patients with a complete response based on physician assessment during the observation period.

    Measured: 24 to 60 months.

  11. Estimate progression-free survival (PFS) among patients diagnosed with MCL and initiating treatment with novel therapies.

    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.

    Measured: 24 to 60 months

  12. Estimate event-free survival (EFS) among patients diagnosed with MCL and initiating treatment with novel therapies.

    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).

    Measured: 24 to 60 months

  13. Estimate overall survival (OS) among patients diagnosed with MCL and initiating treatment with novel therapies.

    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.

    Measured: 24 to 60 months

Secondary outcomes (9)

  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.

    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.

    Measured: 24 to 60 months

  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.

    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.

    Measured: 24 to 60 months

  3. Estimate the frequency of serious adverse events (SAEs) in patients with MCL

    The proportion and frequency patients with SAEs will be tabulated from the start of index novel MCL treatment.

    Measured: 24 to 60 months

  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

    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.

    Measured: 24 to 60 months

  5. Estimate the frequency and proportion of patients experiencing a clinical event of interest (related to MCL or MCL treatment)

    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.

    Measured: 24 to 60 months

  6. Estimate the frequency and proportion of patients experiencing healthcare resource utilization (HCRU), such as inpatient or emergency department visits

    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.

    Measured: 24 to 60 months

  7. Tabulate HRQoL responses for the validated EORTC QLC-C30 Patient Reported Outcome (PRO) in patients with MCL

    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.

    Measured: 24 to 60 months

  8. Tabulate HRQoL responses for the three selected, validated PRO-CTCAE PRO measures in patients with MCL

    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).

    Measured: 24 to 60 months

  9. Tabulate HRQoL responses for the validated PRO EuroQoL 5-Dimension 5-Level (EQ-5D-5L) in patients with MCL

    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.

    Measured: 24 to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2019
  2. Study start1 Apr 2019
  3. Primary completion18 Mar 2024
  4. Study completion18 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03816683
Sponsor's protocol ID
D8220R00004
Acronym
SUMMIT
Status last verified
Nov 2025
First submitted
10 Dec 2018
Last updated
14 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Ahn IE, Farooqui MZH, Tian X, Valdez J, Sun C, Soto S, Lotter J, Housel S, Stetler-Stevenson M, Yuan CM, Maric I, Calvo KR, Nierman P, Hughes TE, Saba NS, Marti GE, Pittaluga S, Herman SEM, Niemann CU, Pedersen LB, Geisler CH, Childs R, Aue G, Wiestner A. Depth and durability of response to ibrutinib in CLL: 5-year follow-up of a phase 2 study. Blood. 2018 May 24;131(21):2357-2366. doi: 10.1182/blood-2017-12-820910. Epub 2018 Feb 26.

    PubMed 29483101

  • AstraZeneca Pharmaceuticals LP. CALQUENCE® (acalabrutinib) prescribing information. October 2017.

  • Chen Y, Wang M, Romaguera J. Current regimens and novel agents for mantle cell lymphoma. Br J Haematol. 2014 Oct;167(1):3-18. doi: 10.1111/bjh.13000. Epub 2014 Jun 28.

    PubMed 24974852

  • Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, Lister TA, Vose J, Grillo-Lopez A, Hagenbeek A, Cabanillas F, Klippensten D, Hiddemann W, Castellino R, Harris NL, Armitage JO, Carter W, Hoppe R, Canellos GP. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999 Apr;17(4):1244. doi: 10.1200/JCO.1999.17.4.1244.

    PubMed 10561185

  • Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.

    PubMed 17242396

  • Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.

    PubMed 25113753

  • ClinicalTrials.gov. Identifier NCT02756247. A Clinical Trial of Buparlisib and Ibrutinib in Lymphoma. Accessed 24 January 2018. Available from: https://clinicaltrials.gov/ct2/show/NCT02756247].

  • ClinicalTrials.gov. Identifier NCT03112174. Study of Ibrutinib Combined with Venetoclax in Subjects with Mantle Cell Lymphoma (SYMPATICO). Accessed 24 January 2018. Available from: https://clinicaltrials.gov/ct2/show/NCT03112174.

  • Collett D. Modelling Survival Data in Medical Research. 3rd edition. Boca Raton, FL: CRC press; 2015.

  • de Claro RA, McGinn KM, Verdun N, Lee SL, Chiu HJ, Saber H, Brower ME, Chang CJ, Pfuma E, Habtemariam B, Bullock J, Wang Y, Nie L, Chen XH, Lu DR, Al-Hakim A, Kane RC, Kaminskas E, Justice R, Farrell AT, Pazdur R. FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia. Clin Cancer Res. 2015 Aug 15;21(16):3586-90. doi: 10.1158/1078-0432.CCR-14-2225.

    PubMed 26275952

  • EORTC Quality of Life Group. EORTC QLQ-C30 Version 3.0. 1995. Accessed 25 January 2018. Available from: http://groups.eortc.be/qol/eortc-qlq-c30.

  • EuroQol Research Foundation. EQ-5D-5L: About. Version 18 April 2017. Accessed 25 January 2018. Available from: https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/.

  • Martin P, Byrtek M, Dawson K, Ziemiecki R, Friedberg JW, Cerhan JR, Flowers CR, Link BK. Patterns of delivery of chemoimmunotherapy to patients with follicular lymphoma in the United States: results of the National LymphoCare Study. Cancer. 2013 Dec 1;119(23):4129-36. doi: 10.1002/cncr.28350. Epub 2013 Sep 4.

    PubMed 24006156

  • Mato AR, Nabhan C, Thompson MC, Lamanna N, Brander DM, Hill B, Howlett C, Skarbnik A, Cheson BD, Zent C, Pu J, Kiselev P, Goy A, Claxton D, Isaac K, Kennard KH, Timlin C, Landsburg D, Winter A, Nasta SD, Bachow SH, Schuster SJ, Dorsey C, Svoboda J, Barr P, Ujjani CS. Toxicities and outcomes of 616 ibrutinib-treated patients in the United States: a real-world analysis. Haematologica. 2018 May;103(5):874-879. doi: 10.3324/haematol.2017.182907. Epub 2018 Feb 1.

    PubMed 29419429

  • National Cancer Institute. Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) (version 1.0). Last updated 24 February 2017. Accessed 25 January 2018. Available from: https://healthcaredelivery.cancer.gov/pro- ctcae/overview.html.

Questions about this trial

What is this clinical trial studying?

An observational study of Mantle Cell Lymphoma, run by AstraZeneca at 32 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The frequency and proportion of patients exposed to each novel agent therapy (time frame: 24 to 60 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03816683, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.

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