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.
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
Study Type
OBSERVATIONAL
Enrollment
50
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, China
RECRUITINGoverall response rate（ORR）
Proportion of patients with complete response (CR) and partial response (PR) after the end of induction therapy.
Time frame: 24 weeks
2-year Progression free survival（PFS24）
Time to first disease progression or death from any cause within two years from enrollment.
Time frame: Up to 4.5 years
2-year Event-free survival（EFS24）
Time to any event, including disease progression, discontinuation of treatment for any reason, or death within two years from enrollment.
Time frame: Up to 4.5 years
Complete response (CR)
Proportion of patients with complete response at the end of treatment
Time frame: 2.5 years
Duration of response (DoR)
Time from enrollment to disease progression or death for patients with a complete or partial response
Time frame: Up to 4.5 years
Overall survival (OS)
Time to death from any cause from the date of enrollment
Time frame: Up to 4.5 years
Safety(Proportion of Grade 3-4 Hematologic and Non-Hematologic Toxicities)
All hematological and non-hematological toxicities from enrollment to 28 days after the end of treatment
Time frame: 4.5 years
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