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

November 28, 2024 updated by: Zhao Weili, Ruijin Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Shanghai Ruijin Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Baseline up to data cut-off (up to approximately 60 months)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: End of treatment visit (approximately 6 months)
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
Time Frame: End of treatment visit (approximately 6 months)
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
Time Frame: From the start of treatment to the initiation of next-line treatment (up to approximately 60 months)
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 Frame: Baseline up to data cut-off (up to approximately 60 months)
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 Frame: Baseline up to data cut-off (up to approximately 60 months)
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
Time Frame: Baseline up to data cut-off (up to approximately 60 months)
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)
Time Frame: Baseline up to data cut-off (up to approximately 60 months)
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life assessed with EORTC QLQ-C30 questionaire
Time Frame: Baseline up to data cut-off (up to approximately 60 months)
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
Time Frame: Baseline up to data cut-off (up to approximately 60 months)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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