Efficacy and Safety of Obinutuzumab in Combination With Lenalidomide in Patients With Relapsed and Refractory Follicular Lymphoma (R/R FL): A Prospective Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Follicular Lymphoma
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- overall response rate（ORR）
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is planned to prospectively observe and verify the efficacy and safety of induction therapy with obinutuzumab in combination with lenalidomide followed by maintenance therapy with obinutuzumab and lenalidomide in patients with R/R FL in a real-world setting in a Chinese population.
Detailed Description
Available data have shown that the combination of obinutuzumab and lenalidomide has shown good efficacy and safety in patients with R/R FL, but the efficacy and safety in Chinese patients remain to be verified. This study is planned to prospectively observe and verify the efficacy and safety of induction therapy with obinutuzumab in combination with lenalidomide followed by maintenance therapy with obinutuzumab and lenalidomide in patients with R/R FL in a real-world setting in a Chinese population. The main questions it aims to answer are: * To assess the ORR in the R/R FL patient population treated with the combination of obinutuzumab and lenalidomide * To assess CRR, PFS, EFS, DOR, OS, and safety in patients with R/R FL treated with the combination of obinutuzumab and lenalidomide Participants in this study will not and should not result in any intervention to the patient's treatment and visits. All treatments and visits for patients will be at the physician's discretion according to clinical practice
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
overall response rate（ORR）
Time Frame: 24 weeks
Proportion of patients with complete response (CR) and partial response (PR) after the end of induction therapy.
Secondary Outcomes
- 2-year Progression free survival（PFS24）(Up to 4.5 years)
- 2-year Event-free survival（EFS24）(Up to 4.5 years)
- Complete response (CR)(2.5 years)
- Duration of response (DoR)(Up to 4.5 years)
- Overall survival (OS)(Up to 4.5 years)
- Safety(Proportion of Grade 3-4 Hematologic and Non-Hematologic Toxicities)(4.5 years)