Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Follicular Lymphoma in Real World Study

Recruiting

• Conditions: Follicular Lymphoma

• Registration Number: NCT05846763
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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

Study Timeline

• Study Start: 2022-11-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-04-27
• Study First Posted: 2023-05-06
• Last Update Submitted: 2023-05-21
• Last Update Posted: 2023-05-23
• Primary Completion: 2026-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall response rate（ORR）	24 weeks	Proportion of patients with complete response (CR) and partial response (PR) after the end of induction therapy.

Secondary Outcome Measures

Name	Time	Method
2-year Progression free survival（PFS24）	Up to 4.5 years	Time to first disease progression or death from any cause within two years from enrollment.
2-year Event-free survival（EFS24）	Up to 4.5 years	Time to any event, including disease progression, discontinuation of treatment for any reason, or death within two years from enrollment.
Complete response (CR)	2.5 years	Proportion of patients with complete response at the end of treatment
Duration of response (DoR)	Up to 4.5 years	Time from enrollment to disease progression or death for patients with a complete or partial response
Overall survival (OS)	Up to 4.5 years	Time to death from any cause from the date of enrollment
Safety(Proportion of Grade 3-4 Hematologic and Non-Hematologic Toxicities)	4.5 years	All hematological and non-hematological toxicities from enrollment to 28 days after the end of treatment

Trial Locations

Locations (1)

Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, China