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

Sponsor

Institute of Hematology & Blood Diseases Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05846763

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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/RFL in a real-world setting in a Chinese population.

Condition or Disease	Intervention/Treatment	Phase
Follicular Lymphoma

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.

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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Efficacy and Safety of Obinutuzumab in Combination With Lenalidomide in Patients With Relapsed and Refractory Follicular Lymphoma (R/R FL): A Prospective Observational Study

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

May 31, 2026

Anticipated Study Completion Date :

May 31, 2028

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The patient voluntarily joined the study and signed the 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 oltuzumab 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