An Observational Study of Glofitamab in Chinese Adult Participants With 2L Diffuse Large B-Cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Glofitamab.
- Who it may be relevant to
- Registry conditions: Diffuse Large B-Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China, Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating Effectiveness and Safety of Glofitamab Based Second-Line Therapy in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter, Cohort Study
Overview
This study will investigate how well glofitamab-based therapy works and how safe it is in Chinese adult participants with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
Interventions
- Drug Glofitamab
Participants will receive glofitamab as part of a cancer-treatment regimen in a real-world setting. No intervention will be administered by study investigators.
Primary outcome measures
- real-world Progression-Free Survival (rwPFS) [Time frame: Up to approximately 4 years]
Secondary outcome measures (8)
- Complete Response Rate (CRR) [Time frame: Up to approximately 4 years]
- Overall Response Rate (ORR) [Time frame: Up to approximately 4 years]
- Disease Control Rate (DCR) [Time frame: Up to approximately 4 years]
- Duration of Response (DoR) [Time frame: Up to approximately 4 years]
- Duration of Complete Response (DoCR) [Time frame: Up to approximately 4 years]
- Overall Survival (OS) [Time frame: Up to approximately 4 years]
- Event-Free Survival (EFS) [Time frame: Up to approximately 4 years]
- Time to Next Treatment (TTNT) [Time frame: Up to approximately 4 years]
Eligibility criteria
Inclusion criteria
- Histologically confirmed R/R DLBCL after one line of systemic therapy
- Will be treated with Glofit-based regimen (known as being recommended and having the intention to be treated with Glofitamab at the time of signing ICF) or have initiated Glofit-based regimen treatment within three months (90 days) prior to enrollment
Exclusion criteria
- Participants who currently participate in or plan to participate in any interventional clinical trial
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 20 centers
- Cancer Hospital Chinese Academy of Medical Sciences. — Langfang
- Chinese Academy of Medical Sciences Hematology Hospital;Lymphoma Diagnosis and Treatment C — Tianjin
- Peking University People's Hospital — Beijing
- Peking University Third Hospital — Beijing
- The First Bethune Hospital of Jilin University — Changchun
- West China Hospital of Sichuan University — Chengdu
- Guangdong Provincial People's Hospital — Guangzhou
- Harbin Medical University Cancer Hospital — Harbin
- … and 12 more centers
Hong Kong · 1 center
- Queen Mary Hospital — Hong Kong
Identifiers
NCT: NCT07200375 · ML45172