Follicular Lymphoma (FL)
Conditions
Brief summary
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
DRUGSCTB35 injection
SCTB35 will be subcutaneously administered at a dose as specified
DRUGRituximab
Intravenous Infusion
DRUGLenalidomide
Oral Capsules
Sponsors
Sinocelltech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Up to approximately 3 years | Treatment-emergent adverse events/serious adverse events/adverse events of special interest |
| Progression free survival (PFS) | Up to approximately 3 years | Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) or the date of death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Best Overall Response (BOR) | Up to approximately 3 years | BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria |
| Percentage of Participants Achieving CR | Up to approximately 3 years | Percentage of participants who achieve a CR determined per Lugano criteria. |
| Overall Survival (OS) | Up to approximately 3 years | Overall survival is defined as the duration from the date of randomization to the date of the participant's death. |
| Duration of Response (DOR) | Up to approximately 3 years | DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first. |
| Time to Response (TTR) | Up to approximately 3 years | Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR. |
| Event-Free Survival (EFS) | Up to approximately 3 years | EFS is defined as the duration from randomization to disease progression determined by Lugano criteria as assessed by the investigator, initiation of any non-protocol-specified new anti-lymphoma therapy for any reason, or death (whichever occurs first). |
| Duration of Complete Response (DOCR) | Up to approximately 3 years | DOCR is defined as the time from the first occurrence of CR to disease progression or death, whichever occurs first. |
| Time to Complete Response (TTCR) | Up to approximately 3 years | Time to complete response is defined for participants achieving a CR as the time from starting therapy to first a CR. |
| Blood Concentrations of SCTB35 | Up to approximately 1 years | The pharmacokinetics of SCTB35 will be analyzed based on the drug concentrations at respective timepoints in the blood samples (or blood derivative) |
| Anti-drug Antibodies of SCTB35 | Up to approximately 3 years | Blood samples (or blood derivative) will be screened for antibodies binding to SCTB35 |
Countries
China
Outcome results
None listed