Clinical trial · Observational
A Disease Registry of Patients With Mantle Cell Lymphoma
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
NCT03816683CI-TRIAL-00097234SUMMITcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Single cohort (registry) of MCL patients
- description
- 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.
Primary outcomes (13)
- measure
- The frequency and proportion of patients exposed to each novel agent therapy
- timeFrame
- 24 to 60 months
- description
- 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.
- measure
- The frequency and proportion of patients exposed to novel agent by therapy regimen
- timeFrame
- 24 to 60 months
- description
- MCL treatment regimens are part of the primary study objective relating to treatment patterns and will be descriptive only and use aggregated patient data.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
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.
References
Publications (25)
- BACKGROUNDAhn 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
- BACKGROUNDAstraZeneca Pharmaceuticals LP. CALQUENCE® (acalabrutinib) prescribing information. October 2017.
- BACKGROUNDChen 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
- BACKGROUNDCheson 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
- BACKGROUNDCheson 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
- BACKGROUNDCheson 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.