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This is a Randomized, Multi-center, Phase 3 Study of Tafasitamab and Lenalidomide in Combination with Gemcitabine and Oxaliplatin versus Rituximab in Combination with Gemcitabine and Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphom
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin | Experimental |
| |
| Rituximab in combination with gemcitabine and oxaliplatin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafasitamab | Drug | Tafasitmab was infused intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity(DLT)and other adverse events (AEs) of tafasitamab and lenalidomide in combination with GemOx (TL-GemOx) assessed using CTCAE v5.0 | within 28 days after therapy initiation | |
| PFS assessed by IRC according to Lugano 2014 | 1-3 years approximately |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) according to investigator. | 1-3 years approximately | |
| Complete Response Rate (CRR) according to investigator. | 1-3 years approximately | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao | Contact | +86 021-64370045 | zwl_trial@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Not yet recruiting | Beijing | China |
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| Lenalidomide | Drug | Lenalidomide orally |
|
| Gemcitabine | Drug | Gemcitabine was infused intravenously |
|
| Oxaliplatin | Drug | Oxaliplatin was infused intravenously |
|
| Rituximab | Drug | Rituximab was infused intravenously. |
|
| Duration of Response (DOR) according to investigator. |
| 1-3 years approximately |
| Progression free survival (PFS) assessed by investigator according to the Lugano 2014 | 1-3 years approximately |
| Time to response (TTR) | 1-3 years approximately |
| Overall Survival (OS) | 1-3 years approximately |
| Time to next treatment (TTNT) | 1-3 years approximately |
| Adverse events assessed by CTCAE version 5.0 criteria. | 1-3 years approximately |
| Quality of life assessment: Patient-reported outcomes (PROs) on happiness and general health status based on Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) | 1-3 years approximately |
| Quality of life assessment: Patient-reported outcomes (PROs) on happiness and general health status based on EuroQol five dimensions questionnaire (EQ-5D-5L) | 1-3 years approximately |
| The First Hospital Of Jilin University | Not yet recruiting | Changchun | China |
|
| Hunan Cancer Hospital | Not yet recruiting | Changsha | China |
|
| Chenzhou No.1 People's Hospital | Not yet recruiting | Chaozhou | China |
|
| Sichuan Province People's Hospital | Recruiting | Chengdu | China |
|
| The First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | China |
|
| Guangdong General Hospital | Not yet recruiting | Guangzhou | China |
|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | China |
|
| Hangzhou First People's Hospital | Not yet recruiting | Hangzhou | China |
|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | China |
|
| Shandong Cancer Hospital and Institute | Not yet recruiting | Jinan | China |
|
| Jiangxi Cancer Hospital | Not yet recruiting | Nanchang | China |
|
| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanjing | China |
|
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Not yet recruiting | Shanghai | China |
|
| The Second Affiliated Hospital of Soochow University | Recruiting | Suzhou | China |
|
| Tianjin First Central Hospital | Not yet recruiting | Tianjin | China |
|
| Xinjiang Medical University Affiliated Cancer Hospital | Not yet recruiting | Ürümqi | China |
|
| The First Affiliated Hospital Wenzhou Medical University | Not yet recruiting | Wenzhou | China |
|
| Union Hospital Tongji Medical College | Not yet recruiting | Wuhan | China |
|
| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | China |
|
| ID | Term |
|---|---|
| C000613469 | tafasitamab |
| D000077269 | Lenalidomide |
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| 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 |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D056831 | Coordination Complexes |
| 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 |
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