Actively Recruiting
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
Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2024-07-25
244
Participants Needed
20
Research Sites
290 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years and older
- Confirmed histology of DLBCL including T-cell/histiocyte-rich large B-cell lymphoma, EBV-positive DLBCL, composite lymphoma with DLBCL component, or transformed low-grade lymphoma with DLBCL relapse
- Availability of tumor tissue biopsy after last therapy and before current study treatment for safety stage patients
- Relapsed or refractory DLBCL with 1 to 3 prior systemic therapies
- Ineligible for high dose therapy or stem cell transplantation if not previously received
- At least one measurable disease site with lymph node lesion >1.5 cm or extra-nodal lesion >1.0 cm
- ECOG performance status score of 0 to 2
- Adequate organ function and laboratory values meeting protocol requirements
- Life expectancy of at least 3 months
- Able to provide informed consent and comply with study requirements
You will not qualify if you...
- History of other malignant tumors within 3 years except curatively treated cases
- Current or prior central nervous system lymphoma
- High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
- Primary mediastinal B-cell lymphoma
- History of allogeneic stem-cell transplantation
- Previous anti-CD19 treatment or failure with gemcitabine plus platinum-based therapy
- Current toxicity grade 2 or higher from prior anti-cancer therapy except alopecia, neutrophil, hemoglobin, or platelets
- Significant cardiovascular or nervous system disease
- History or high risk of thromboembolism without prophylaxis willingness
- Uncontrolled systemic infection needing intravenous anti-infective therapy
- Known HIV or active hepatitis B or C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Beijing Hospital
Beijing, China
Not Yet Recruiting
2
The First Hospital Of Jilin University
Changchun, China
Not Yet Recruiting
3
Hunan Cancer Hospital
Changsha, China
Not Yet Recruiting
4
Chenzhou No.1 People's Hospital
Chaozhou, China
Not Yet Recruiting
5
Sichuan Province People's Hospital
Chengdu, China
Actively Recruiting
6
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Not Yet Recruiting
7
Guangdong General Hospital
Guangzhou, China
Not Yet Recruiting
8
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
9
Hangzhou First People's Hospital
Hangzhou, China
Not Yet Recruiting
10
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Not Yet Recruiting
11
Shandong Cancer Hospital and Institute
Jinan, China
Not Yet Recruiting
12
Jiangxi Cancer Hospital
Nanchang, China
Not Yet Recruiting
13
The First Affiliated Hospital of Nanchang University
Nanjing, China
Not Yet Recruiting
14
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China
Not Yet Recruiting
15
The Second Affiliated Hospital of Soochow University
Suzhou, China
Actively Recruiting
16
Tianjin First Central Hospital
Tianjin, China
Not Yet Recruiting
17
Xinjiang Medical University Affiliated Cancer Hospital
Ürümqi, China
Not Yet Recruiting
18
The First Affiliated Hospital Wenzhou Medical University
Wenzhou, China
Not Yet Recruiting
19
Union Hospital Tongji Medical College
Wuhan, China
Not Yet Recruiting
20
Henan Cancer Hospital
Zhengzhou, China
Not Yet Recruiting
Research Team
W
Weili Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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