Combining obinutuzumab and lenalidomide for treating relapsed follicular lymphoma
Efficacy and Safety of Obinutuzumab in Combination With Lenalidomide in Patients With Relapsed and Refractory Follicular Lymphoma (R/R FL): A Prospective Observational Study
This study is testing if combining obinutuzumab and lenalidomide can help people in China with relapsed follicular lymphoma feel better and live longer, while keeping their current treatment plans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | obinutuzumab, chemotherapy |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT05846763 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy and safety of obinutuzumab in combination with lenalidomide for patients with relapsed or refractory follicular lymphoma (R/R FL) in a real-world setting in China. It will assess various outcomes including overall response rate (ORR), complete response rate (CRR), progression-free survival (PFS), event-free survival (EFS), duration of response (DOR), overall survival (OS), and safety. The study will not involve any changes to the patients' treatment plans, as all interventions will be at the discretion of their physicians. The goal is to verify the previously observed efficacy and safety of this combination specifically in the Chinese patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of at least one prior line of systemic therapy for follicular lymphoma who are relapsed or refractory to previous treatments.
Not a fit: Patients currently participating in interventional clinical trials or deemed unsuitable by the investigator will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into effective treatment options for patients with relapsed or refractory follicular lymphoma.
How similar studies have performed: Previous studies have indicated good efficacy and safety of the obinutuzumab and lenalidomide combination, but this specific study aims to confirm these findings in a Chinese population.
Eligibility criteria
Show full inclusion / exclusion criteria
Patients must meet the following criteria for study entry:: * Signed Informed Consent Form * Age ≥ 18 years at enrollment * At least one prior line of systemic (Stage III-IV) follicular lymphoma therapy * Relapsed or refractory to front-line anti-lymphoma therapy; refractory is defined as: tumor shrinkage of less than 50% or disease progression after 4 cycles of standard regimen chemotherapy; response to standard regimen chemotherapy, relapse within 24 months; 2 or more relapses, meeting one of the above criteria as refractory lymphoma. * Conditional treatment with obinutuzumab in combination with lenalidomide Exclusion Criteria: * Patients currently participating or planning to participate in any interventional clinical trial * Any other reason that, in the opinion of the investigator, makes the patient unsuitable for this study
Where this trial is running
Tianjin
- Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences — Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Shuhua Yi, Dr — Institute of Hematology & Blood Diseases Hospital, Chinese
- Study coordinator: shuhua Yi, Dr
- Email: yishuhua@ihcams.ac.cn
- Phone: 86-22-23909106
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.