Observing the effects of obinutuzumab for untreated follicular lymphoma
A Real-world Study of the Efficacy and Safety of Obinutuzumab-based Therapy for Previously Untreated Follicular Lymphoma
This study looks at how well the drug obinutuzumab works and how safe it is for people with untreated follicular lymphoma in real-life settings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 332 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | obinutuzumab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05899621 on ClinicalTrials.gov |
What this trial studies
This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for patients with previously untreated follicular lymphoma. It is a non-interventional, real-world observational study that collects data from actual clinical practice cases. The study will gather comprehensive medical data, including patient demographics, tumor characteristics, laboratory results, treatment history, adverse reactions, efficacy outcomes, and potential prognostic factors.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with pathologically confirmed CD20 positive follicular lymphoma who have not received prior treatment.
Not a fit: Patients with transformed follicular lymphoma, those with certain viral infections, or individuals deemed unsuitable by researchers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of obinutuzumab-based therapies for treating follicular lymphoma.
How similar studies have performed: Other studies have shown promising results with obinutuzumab in treating follicular lymphoma, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification * Treatment naive * Age ≥ 18 years * Indications for treatment confirmed * Must has measurable lesion in CT or PET-CT prior to treatment * Considered suitable for GR, GB or GCHOP regimens * Informed consented Exclusion Criteria: * Transformed follicular lymphoma or 3B follicular lymphoma; * HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive * Central nervous system or meninges involved * Any drug contraindication in the treatment plan * Patients judged by other researchers to be unsuitable for inclusion in the study
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Weili Zhao, +862164370045
- Email: zwl_trial@163.com
- Phone: +862164370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.