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

NCT06534463 | Recruiting

• 1 other identifier: MOTIVE
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Marginal Zone Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Overall Response Rate

  End of treatment visit (approximately 6 months)

• Complete Response Rate

  End of treatment visit (approximately 6 months)

• Time to Next Treatment

  From the start of treatment to the initiation of next-line treatment (up to approximately 60 months)

• Duration of Response

  Baseline up to data cut-off (up to approximately 60 months)

• Duration of Complete Response

  Baseline up to data cut-off (up to approximately 60 months)

Other Outcomes (2)

• Health-Related Quality of Life assessed with EORTC QLQ-C30 questionaire

  Baseline up to data cut-off (up to approximately 60 months)

• Health-Related Quality of Life assessed with EORTC QLQ-NHL-LG20 questionaire

  Baseline up to data cut-off (up to approximately 60 months)

Study Arms (1)

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.

Interventions

All treatment regimen selections and usage will be determined by the physician based on clinical practice and/or the respective drug labels in China. OTHER

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.

Observational Cohort

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Weili Zhao

CONTACT

+862164370045; zwl_trial@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of hospital

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: August 2, 2024
• Study Start: August 2, 2024
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)