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NCT Number: NCT06534463

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

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.

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Weili Zhao, M.D. and Ph.D

CONTACT

[email protected]

+86021-64370045

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Other outcomes

  1. 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) .

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Weili Zhao

CONTACT

[email protected]

+862164370045 ext. 610707

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Acronym: MOTIVE

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Aug 2, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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