A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SCTB35 injection, Rituximab, Lenalidomide.
- Who it may be relevant to
- Registry conditions: Follicular Lymphoma (FL). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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).
Interventions
- Drug SCTB35 injection
SCTB35 will be subcutaneously administered at a dose as specified - Drug Rituximab
Intravenous Infusion - Drug Lenalidomide
Oral Capsules
Primary outcome measures
- Adverse Events [Time frame: Up to approximately 3 years]
- Progression free survival (PFS) [Time frame: Up to approximately 3 years]
Secondary outcome measures (10)
- Percentage of Participants Achieving Best Overall Response (BOR) [Time frame: Up to approximately 3 years]
- Percentage of Participants Achieving CR [Time frame: Up to approximately 3 years]
- Overall Survival (OS) [Time frame: Up to approximately 3 years]
- Duration of Response (DOR) [Time frame: Up to approximately 3 years]
- Time to Response (TTR) [Time frame: Up to approximately 3 years]
- Event-Free Survival (EFS) [Time frame: Up to approximately 3 years]
- Duration of Complete Response (DOCR) [Time frame: Up to approximately 3 years]
- Time to Complete Response (TTCR) [Time frame: Up to approximately 3 years]
- Blood Concentrations of SCTB35 [Time frame: Up to approximately 1 years]
- Anti-drug Antibodies of SCTB35 [Time frame: Up to approximately 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT07562022 · SCTB35-A301