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The purpose of this study is to evaluate the efficacy and safety of SCTB35 in Combination With Gemcitabine and Oxaliplatin vs Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCTB35-GemOx | Experimental |
| |
| R-GemOx | 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 |
|---|---|---|
| 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 |
| Percentage of Participants Achieving Best Overall Response (BOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | 100142 | China |
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| Rituxumab |
| Drug |
Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles. |
|
| Gemcitabine | Drug | Participants will receive IV gemcitabine administration for up to 8 cycles. |
|
| Oxaliplatin | Drug | Participants will receive IV oxaliplatin administration for up to 8 cycles. |
|
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 | Percentage of participants who achieve a CR determined per Lugano criteria. | 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
|---|---|
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| ID | Term |
|---|---|
| D015620 | Histiocytic Disorders, Malignant |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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