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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
SCTB35 will be subcutaneously administered at a dose as specified
Intravenous Infusion
Oral Capsules
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGAdverse Events
Treatment-emergent adverse events/serious adverse events/adverse events of special interest
Time frame: Up to approximately 3 years
Progression free survival (PFS)
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.
Time frame: Up to approximately 3 years
Percentage of Participants Achieving Best Overall Response (BOR)
BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria
Time frame: Up to approximately 3 years
Percentage of Participants Achieving CR
Percentage of participants who achieve a CR determined per Lugano criteria.
Time frame: Up to approximately 3 years
Overall Survival (OS)
Overall survival is defined as the duration from the date of randomization to the date of the participant's death.
Time frame: Up to approximately 3 years
Duration of Response (DOR)
DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.
Time frame: Up to approximately 3 years
Time to Response (TTR)
Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.
Time frame: Up to approximately 3 years
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Event-Free Survival (EFS)
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).
Time frame: Up to approximately 3 years
Duration of Complete Response (DOCR)
DOCR is defined as the time from the first occurrence of CR to disease progression or death, whichever occurs first.
Time frame: Up to approximately 3 years
Time to Complete Response (TTCR)
Time to complete response is defined for participants achieving a CR as the time from starting therapy to first a CR.
Time frame: Up to approximately 3 years
Blood Concentrations of SCTB35
The pharmacokinetics of SCTB35 will be analyzed based on the drug concentrations at respective timepoints in the blood samples (or blood derivative)
Time frame: Up to approximately 1 years
Anti-drug Antibodies of SCTB35
Blood samples (or blood derivative) will be screened for antibodies binding to SCTB35
Time frame: Up to approximately 3 years