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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCTB35 and Lenalidomide | Experimental |
| |
| Rituximab and Lenalidomide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCTB35 injection | Drug | SCTB35 will be subcutaneously administered at a dose as specified |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Treatment-emergent adverse events/serious adverse events/adverse events of special interest | 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. | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Best Overall Response (BOR) | BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria | Up to approximately 3 years |
| Percentage of Participants Achieving CR |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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| Rituximab | Drug | Intravenous Infusion |
|
| Lenalidomide | Drug | Oral Capsules |
|
Percentage of participants who achieve a CR determined per Lugano criteria.
| 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. | 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. | 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. | Up to approximately 3 years |
| 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). | 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. | 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. | 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) | Up to approximately 1 years |
| Anti-drug Antibodies of SCTB35 | Blood samples (or blood derivative) will be screened for antibodies binding to SCTB35 | Up to approximately 3 years |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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