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
- Conditions
- DLBCL
- Interventions
- Registration Number
- NCT06521255
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 244
- 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.
- 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.
- Known high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements.
- Primary mediastinal B-cell lymphoma.
- History of allogeneic stem-cell transplantation.
- Prior exposure to anti-CD19 treatment, and (or) failed with gemcitabine plus platinum-based agent combination therapy.
- Current toxicity of ≥ Grade 2 from prior anti-cancer therapy (except for alopecia, neutrophil, hemoglobin and platelets).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin Gemcitabine - Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin Tafasitamab - Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin Lenalidomide - Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin Oxaliplatin - Rituximab in combination with gemcitabine and oxaliplatin Oxaliplatin - Rituximab in combination with gemcitabine and oxaliplatin Gemcitabine - Rituximab in combination with gemcitabine and oxaliplatin Rituximab -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Overall Survival (OS) 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 Duration of Response (DOR) according to investigator. 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 Time to response (TTR) 1-3 years approximately Objective Response Rate (ORR) according to investigator. 1-3 years approximately Complete Response Rate (CRR) 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 next treatment (TTNT) 1-3 years approximately
Trial Locations
- Locations (20)
Xinjiang Medical University Affiliated Cancer Hospital
🇨🇳Urumqi, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
Beijing Hospital
🇨🇳Beijing, China
Hunan Cancer Hospital
🇨🇳Changsha, China
Chenzhou No.1 People's Hospital
🇨🇳Chaozhou, China
The First Hospital Of Jilin University
🇨🇳Changchun, China
Guangdong General Hospital
🇨🇳Guangzhou, China
Sichuan Province People's Hospital
🇨🇳Chengdu, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Shandong Cancer Hospital and Institute
🇨🇳Jinan, China
Hangzhou First People's Hospital
🇨🇳Hangzhou, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
Tianjin First Central Hospital
🇨🇳Tianjin, China
Union Hospital Tongji Medical College
🇨🇳Wuhan, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, China
The First Affiliated Hospital Wenzhou Medical University
🇨🇳Wenzhou, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanjing, China