Clinical trial · Observational
Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Follicular Lymphoma in Real World Study
Efficacy and Safety of Obinutuzumab in Combination With Lenalidomide in Patients With Relapsed and Refractory Follicular Lymphoma (R/R FL): A Prospective Observational Study
NCT05846763CI-TRIAL-00066613recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- overall response rate（ORR）
- timeFrame
- 24 weeks
- description
- Proportion of patients with complete response (CR) and partial response (PR) after the end of induction therapy.
Secondary outcomes (6)
- measure
- 2-year Progression free survival（PFS24）
- timeFrame
- Up to 4.5 years
- description
- Time to first disease progression or death from any cause within two years from enrollment.
- measure
- 2-year Event-free survival（EFS24）
- timeFrame
- Up to 4.5 years
- description
- Time to any event, including disease progression, discontinuation of treatment for any reason, or death within two years from enrollment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.