Clinical trial · Interventional
A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma
A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide Versus Rituximab and Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma
NCT07562022CI-TRIAL-00121833recruitingPhase 3ClinicalTrials.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)
The purpose of this study is to evaluate the efficacy and safety of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular lymphoma (FL).
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 (FL) | Follicular Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| SCTB35 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SCTB35 and Lenalidomide
- interventionNames
- Drug: SCTB35 injection
- Drug: Lenalidomide
- type
- ACTIVE_COMPARATOR
- label
- Rituximab and Lenalidomide
- interventionNames
- Drug: Rituximab
- Drug: Lenalidomide
Primary outcomes (2)
- measure
- Adverse Events
- timeFrame
- Up to approximately 3 years
- description
- Treatment-emergent adverse events/serious adverse events/adverse events of special interest
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-80 years old * Histologically confirmed Follicular lymphoma (FL) grade 1, 2, or 3a according to WHO 2022 criteria * Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy * Judged by the investigator, the participant must urgently need to receive systemic treatment, based on meeting at least one GELF criterion * A measurable or evaluable disease at the time of enrolment * ECOG PS 0-2 * Adequate organ function and bone marrow function * Expected survival ≥ 6 months Exclusion Criteria: * Documented refractoriness to lenalidomide. * Have lenalidomide exposure within 12 months prior to randomization
References
Publications (0)
Data not yet available
No reference posted for this study.