The Effectiveness and Safety of Glofitamab in Real-World Clinical Practice Among Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter Study

Sponsor
Ruijin Hospital
Study ID
NCT06656234
Status
Not Yet Recruiting

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Conditions

  • Diffuse Large B Cell Lymphoma (DLBCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glofitamab — DRUG
    Glofitamab will be administered at the discretion of the physician per local clinical practice and local labeling.
  • Obinutuzumab — DRUG
    Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.

Study Details

The purpose of this study is to evaluate the the efficacy and safety in the real-world settings of glofitamab among Chinese R/R DLBCL participants.

Key Dates

Start date
Oct 30, 2024
Status verified
Oct 2024
Primary completion
Sep 15, 2027
Completion
Sep 15, 2028

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Cohort 1
    Participants with relapsed or refractory (R/R) DLBCL who have started receiving glofitamab at physician's discretion in accordance with local clinical practice and/or labeling will be observed for safety and efficacy until death, withdrawal of consent, loss to follow-up or end of study whichever occurs first (up to approximately 4 years).

Primary Outcome Measure

Progression free survival (PFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [ Time Frame: Baseline up to end of study (EOS) (approximately 48 months) ]

Central Contacts

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