Registry Study of Chinese Patients with Marginal Zone Lymphoma (MOTIVE) (MOTIVE)

The Effectiveness and Safety of Different Treatment Modalities in Real-World Clinical Practice Among Chinese Patients with Marginal Zone Lymphoma: a Prospective, Observational, Multi-center Study

This study aims to evaluate real-world treatment modalities and their corresponding effectiveness and safety in Chinese patients with marginal zone lymphoma, while also exploratively analyzing patient characteristics and health-related quality of life.

Study Overview

• Status: Recruiting
• Conditions: Marginal Zone Lymphoma
• Intervention / Treatment: Other: All treatment regimen selections and usage will be determined by the physician based on clinical practice and/or the respective drug labels in China.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Weili Zhao; Phone Number: 610707 +862164370045; Email: zwl_trial@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Shanghai Ruijin Hospital
      • Contact: Weili Zhao, M.D. and Ph.D; Phone Number: +86021-64370045; Email: zwl_trial@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants who are about to undergo marginal zone lymphoma(MZL) treatment (i.e., those who have been recommended for and intend to receive MZL treatment at the time of signing the informed consent form)

Description

Inclusion Criteria:

• Be diagnosed as MZL
• Meet the treatment indications for MZL

Exclusion Criteria:

• Any reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational Cohort; Including newly diagnosed marginal zone lymphoma (MZL) and relapse/refractory MZL participants who meet the treatment indications for MZL and are about to undergo MZL treatment.

Other: All treatment regimen selections and usage will be determined by the physician based on clinical practice and/or the respective drug labels in China.; The dosage and duration of any drug in this study will be determined by the physician based on local clinical practice and local drug labels. The drugs in this study include, but are not limited to, Obinutuzumab, Rituximab, Bruton tyrosine kinase inhibitors, and Lenalidomide. In this non-interventional study, all treatment drug usage will be determined by the physician based on clinical practice and/or the respective drug labels in China.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.	Baseline up to data cut-off (up to approximately 60 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate	Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria.	End of treatment visit (approximately 6 months)
Complete Response Rate	Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.	End of treatment visit (approximately 6 months)
Time to Next Treatment	From the start of treatment to the initiation of next-line treatment	From the start of treatment to the initiation of next-line treatment (up to approximately 60 months)
Duration of Response	Time from first occurrence of documented complete response or partial response to disease progression/relapse, or death from any cause for participants, whichever occurs first.	Baseline up to data cut-off (up to approximately 60 months)
Duration of Complete Response	Time from the first occurrence of a documented complete response to the date of progression, relapse, or death from any cause, whichever occurs first.	Baseline up to data cut-off (up to approximately 60 months)
Overall survival	Overall survival was defined as the time from the date of diagnosis to the date of death from any cause.	Baseline up to data cut-off (up to approximately 60 months)
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.	Baseline up to data cut-off (up to approximately 60 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-Related Quality of Life assessed with EORTC QLQ-C30 questionaire	Patient-reported outcomes using The European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30) .	Baseline up to data cut-off (up to approximately 60 months)
Health-Related Quality of Life assessed with EORTC QLQ-NHL-LG20 questionaire	Patient-reported outcomes using The European Organization for Research and Treatment of Cancer Quality of Life questionnaire including 20 items for patients with low-grade non-Hodgkin lymphoma (EORTC QLQ-NHL-LG20).	Baseline up to data cut-off (up to approximately 60 months)

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2024
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: July 21, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Lymphoma, B-Cell, Marginal Zone
• Other Study ID Numbers: MOTIVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No