Follicular Lymphoma
Conditions
Keywords
follicular lymphoma, Obinutuzumab, Lenalidomide, real-world
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
Interventions
None listed
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate（ORR） | 24 weeks | Proportion of patients with complete response (CR) and partial response (PR) after the end of induction therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| 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 |
| Overall survival (OS) | Up to 4.5 years | Time to death from any cause from the date of enrollment |
Countries
China
Contacts
Primary Contactshuhua Yi, Dr
Backup ContactLugui Qiu, Dr
Outcome results
None listed