Tests tafasitamab and lenalidomide with chemotherapy in relapsed lymphoma
Compares tafasitamab and lenalidomide with chemotherapy against rituximab with chemotherapy in adults with lymphoma.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Beijing, Changchun, Changsha, Chaozhou, Chengdu, Chongqing, Guangzhou, Hangzhou, Jinan, Nanchang, Nanjing, Shanghai, Suzhou, Tianjin, Ürümqi, Wenzhou, Wuhan, and Zhengzhou, ChinaSee the 20 sites
- Phase
- Phase 3
Where in China
- Beijing HospitalBeijing, ChinaNot yet recruiting
- The First Hospital of Jilin UniversityChangchun, ChinaNot yet recruiting
- Hunan Cancer HospitalChangsha, ChinaNot yet recruiting
- Chenzhou No.1 People's HospitalChaozhou, ChinaNot yet recruiting
- Sichuan Province People's HospitalChengdu, ChinaTaking people
- The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaNot yet recruiting
- Guangdong General HospitalGuangzhou, ChinaNot yet recruiting
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaTaking people
- Hangzhou First People's HospitalHangzhou, ChinaNot yet recruiting
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaNot yet recruiting
- Shandong Cancer Hospital and InstituteJinan, ChinaNot yet recruiting
- Jiangxi Cancer HospitalNanchang, ChinaNot yet recruiting
- The First Affiliated Hospital of Nanchang UniversityNanjing, ChinaNot yet recruiting
- Ruijin Hospital Shanghai Jiaotong University School of MedicineShanghai, ChinaNot yet recruiting
- The Second Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
- Tianjin First Central HospitalTianjin, ChinaNot yet recruiting
- Xinjiang Medical University Affiliated Cancer HospitalÜrümqi, ChinaNot yet recruiting
- The First Affiliated Hospital Wenzhou Medical UniversityWenzhou, ChinaNot yet recruiting
- Union Hospital Tongji Medical CollegeWuhan, ChinaNot yet recruiting
- Henan Cancer HospitalZhengzhou, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing InnoCare Pharma Tech Co., Ltd.
- Trial code
- NCT06521255
- Record updated
- 25 July 2024
- Original description
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 LymphomRead full original descriptionShow less
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 Lymphoma
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
Inclusion: 18 Years and older; One of the histologies of DLBCL confirmed by participated sites below with，not otherwise specified;T-cell/histiocyte-rich large B-cell lymphoma;Epstein-Barr virus (EBV) positive DLBCL (EBV-positive DLBCL); Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse; Disease transformed from an earlier diagnosis of low-grade lymphoma into DLBCL with DLBCL treatment failure; Availability of tumor tissue biopsied post last line of therapy and prior to current study treatment for the patients enrolled in safety and tolerability stage; Relapsed/refractory (R/R) DLBCL, at least one (≥1) but no more than three (≤3) line of prior systemic therapies; Patients who have not received high dose therapy/stem cell transplantation (HDT/SCT) must be ineligible for HDT/SCT; At least one measurable site of disease per CT or magnetic resonance imaging (the longest axis of the lymph node lesion is > 1.5 cm, and the longest diameter of the extra-nodal lesion is > 1.0 cm); ECOG PS score of 0 to 2; Subject must have adequate organ functions, and the laboratory values comply with the protocol requirements; Life expectancy of ≥ 3 months; Informed consent before screening and can understand and comply with the requirements of the study.
Exclusion: Prior exposure to anti-CD19 treatment, and (or) failed with gemcitabine plus platinum-based agent combination therapy; Existing or prior history of other malignant tumor within 3 years, except for those who have received curative treatment; Current or history of central nervous system (CNS) lymphoma; History of allogeneic stem-cell transplantation; Clinically significant cardiovascular disease or nervous system disease; History of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period; Uncontrolled systemic infection requiring parenteral intravenous anti-infective therapy; Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B or C infection; Current toxicity of ≥ Grade 2 from prior anti-cancer therapy (except for alopecia, neutrophil, hemoglobin and platelets); Known high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements; Primary mediastinal B-cell lymphoma.