Evaluate the Safety and Efficacy 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 Lymphoma
NCT Number: NCT06521255
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: DLBCL
Interventions: DRUG: Tafasitamab|DRUG: Lenalidomide|DRUG: Gemcitabine|DRUG: Oxaliplatin|DRUG: Rituximab
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 244
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-07
Completion Date: 2029-12
Locations: Beijing Hospital, Beijing, China|The First Hospital Of Jilin University, Changchun, China|Hunan Cancer Hospital, Changsha, China|Chenzhou No.1 People's Hospital, Chaozhou, China|Sichuan Province People's Hospital, Chengdu, China|The First Affiliated Hospital of Chongqing Medical University, Chongqing, China|Guangdong General Hospital, Guangzhou, China|Sun Yat-sen University Cancer Center, Guangzhou, China|Hangzhou First People's Hospital, Hangzhou, China|The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China|Shandong Cancer Hospital and Institute, Jinan, China|Jiangxi Cancer Hospital, Nanchang, China|The First Affiliated Hospital of Nanchang University, Nanjing, China|Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China|The Second Affiliated Hospital of Soochow University, Suzhou, China|Tianjin First Central Hospital, Tianjin, China|Xinjiang Medical University Affiliated Cancer Hospital, Urumqi, China|The First Affiliated Hospital Wenzhou Medical University, Wenzhou, China|Union Hospital Tongji Medical College, Wuhan, China|Henan Cancer Hospital, Zhengzhou, China

Summary:
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

Primary Outcome Measures: 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
Secondary Outcome Measures: Objective Response Rate (ORR) according to investigator., 1-3 years approximately|Complete Response Rate (CRR) according to investigator., 1-3 years approximately|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