A Disease Registry of Patients With Mantle Cell Lymphoma

NCT03816683 | Completed

• 1 other identifier: D8220R00004
• Study Type: observational
• Target: 227
• Locations: 1 country
• Sites: 32

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.

Conditions

Mantle Cell Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (13)

• 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.

  24 to 60 months

• 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.

  24 to 60 months

• 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.

  24 to 60 months

• 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.

  24 to 60 months.

• 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.

  24 to 60 months.

• 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.

  24 to 60 months

• 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.

  24 to 60 months

• 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.

  24 to 60 months

• 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.

  24 to 60 months.

• 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.

  24 to 60 months.

• 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.

  24 to 60 months

• 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).

  24 to 60 months

• 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.

  24 to 60 months

Secondary Outcomes (9)

• The frequency of adverse events (AEs) in patients with MCL, where the term AE is used to include both serious and non-serious AEs.

  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.

  24 to 60 months

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

  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

  24 to 60 months

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

  24 to 60 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (32)

Research Site

Montgomery, Alabama, 36101, United States

Location

Research Site

Clovis, California, 93611, United States

Location

Research Site

Boulder, Colorado, 80303-1385, United States

Location

Research Site

Jacksonville, Florida, 32256, United States

Location

Research Site

Pensacola, Florida, 32503, United States

Location

Research Site

Tampa, Florida, 33612-9497, United States

Location

Research Site

Atlanta, Georgia, 30322, United States

Location

Research Site

Augusta, Georgia, 30912, United States

Location

Research Site

Chicago, Illinois, 60612, United States

Location

Research Site

Iowa City, Iowa, 52242, United States

Location

Research Site

Ann Arbor, Michigan, 48109, United States

Location

Research Site

Duluth, Minnesota, 55805, United States

Location

Research Site

Saint Louis Park, Minnesota, 55416, United States

Location

Research Site

Saint Paul, Minnesota, 55102, United States

Location

Research Site

Lincoln, Nebraska, 68510, United States

Location

Research Site

Berkeley Heights, New Jersey, 07922, United States

Location

Research Site

Hackensack, New Jersey, 07601, United States

Location

Research Site

East Syracuse, New York, 13057, United States

Location

Research Site

New York, New York, 10022, United States

Location

Research Site

Eugene, Oregon, 97401-8122, United States

Location

Research Site

Danville, Pennsylvania, 17822, United States

Location

Research Site

Philadelphia, Pennsylvania, 19104, United States

Location

Research Site

Philadelphia, Pennsylvania, 19111, United States

Location

Research Site

Nashville, Tennessee, 37232, United States

Location

Research Site

Dallas, Texas, 75231, United States

Location

Research Site

Dallas, Texas, 75390, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

Research Site

Seattle, Washington, 98122, United States

Location

Research Site

Seattle, Washington, 98195-9472, United States

Location

Research Site

Morgantown, West Virginia, 26506, United States

Location

Research Site

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (25)

• 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.

  PMID: 29483101 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 24974852 BACKGROUND

• 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.

  PMID: 10561185 BACKGROUND

• 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.

  PMID: 17242396 BACKGROUND

• 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.

  PMID: 25113753 BACKGROUND

• 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].

  BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 26275952 BACKGROUND

• 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.

  BACKGROUND

• 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/.

  BACKGROUND

• 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.

  PMID: 24006156 BACKGROUND

• 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.

  PMID: 29419429 BACKGROUND

• 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.

  BACKGROUND

• National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Non-Hodgkin's Lymphomas. 2014. Version 4.2014.

  BACKGROUND

• Steiner RE, Romaguera J, Wang M. Current trials for frontline therapy of mantle cell lymphoma. J Hematol Oncol. 2018 Jan 27;11(1):13. doi: 10.1186/s13045-018-0556-x.

  PMID: 29374487 BACKGROUND

• Tam CS, Roberts AW, Anderson M, Dawson S, Hicks R, Burbury K, et al. Combination ibrutinib (Ibr) and venetoclax (Ven) for the treatment of mantle cell lymphoma (MCL): primary endpoint assessment of the phase 2 AIM study. Hematol Oncol. 2017;35(S2):144-5.

  BACKGROUND

• Teras LR, DeSantis CE, Cerhan JR, Morton LM, Jemal A, Flowers CR. 2016 US lymphoid malignancy statistics by World Health Organization subtypes. CA Cancer J Clin. 2016 Nov 12;66(6):443-459. doi: 10.3322/caac.21357. Epub 2016 Sep 12.

  PMID: 27618563 BACKGROUND

• Wang M, Rule S, Zinzani PL, Goy A, Casasnovas O, Smith SD, Damaj G, Doorduijn J, Lamy T, Morschhauser F, Panizo C, Shah B, Davies A, Eek R, Dupuis J, Jacobsen E, Kater AP, Le Gouill S, Oberic L, Robak T, Covey T, Dua R, Hamdy A, Huang X, Izumi R, Patel P, Rothbaum W, Slatter JG, Jurczak W. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018 Feb 17;391(10121):659-667. doi: 10.1016/S0140-6736(17)33108-2. Epub 2017 Dec 11.

  PMID: 29241979 BACKGROUND

• Witzig TE. Current treatment approaches for mantle-cell lymphoma. J Clin Oncol. 2005 Sep 10;23(26):6409-14. doi: 10.1200/JCO.2005.55.017.

  PMID: 16155027 BACKGROUND

• Wu J, Liu C, Tsui ST, Liu D. Second-generation inhibitors of Bruton tyrosine kinase. J Hematol Oncol. 2016 Sep 2;9(1):80. doi: 10.1186/s13045-016-0313-y.

  PMID: 27590878 BACKGROUND

• Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.

  PMID: 9095563 BACKGROUND

• Younes A, Hilden P, Coiffier B, Hagenbeek A, Salles G, Wilson W, Seymour JF, Kelly K, Gribben J, Pfreunschuh M, Morschhauser F, Schoder H, Zelenetz AD, Rademaker J, Advani R, Valente N, Fortpied C, Witzig TE, Sehn LH, Engert A, Fisher RI, Zinzani PL, Federico M, Hutchings M, Bollard C, Trneny M, Elsayed YA, Tobinai K, Abramson JS, Fowler N, Goy A, Smith M, Ansell S, Kuruvilla J, Dreyling M, Thieblemont C, Little RF, Aurer I, Van Oers MHJ, Takeshita K, Gopal A, Rule S, de Vos S, Kloos I, Kaminski MS, Meignan M, Schwartz LH, Leonard JP, Schuster SJ, Seshan VE. International Working Group consensus response evaluation criteria in lymphoma (RECIL 2017). Ann Oncol. 2017 Jul 1;28(7):1436-1447. doi: 10.1093/annonc/mdx097.

  PMID: 28379322 BACKGROUND

• Yun S, Vincelette ND, Acharya U, Abraham I. Risk of Atrial Fibrillation and Bleeding Diathesis Associated With Ibrutinib Treatment: A Systematic Review and Pooled Analysis of Four Randomized Controlled Trials. Clin Lymphoma Myeloma Leuk. 2017 Jan;17(1):31-37.e13. doi: 10.1016/j.clml.2016.09.010. Epub 2016 Sep 19.

  PMID: 27780690 BACKGROUND

Related Links

• Redacted CSR synopsis

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard Hermann

  Senior Medical Director, Haematology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: January 25, 2019
• Study Start: April 1, 2019
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• 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

Locations

US (32)