Trial 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
NCT ID:
NCT06521255
Condition:
DLBCL
Conditions: Official terms:
Lymphoma, Large B-Cell, Diffuse
Rituximab
Gemcitabine
Oxaliplatin
Lenalidomide
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tafasitamab
Description:
Tafasitmab was infused intravenously
Arm group label:
Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Lenalidomide orally
Arm group label:
Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine was infused intravenously
Arm group label:
Rituximab in combination with gemcitabine and oxaliplatin
Arm group label:
Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin was infused intravenously
Arm group label:
Rituximab in combination with gemcitabine and oxaliplatin
Arm group label:
Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Rituximab was infused intravenously.
Arm group label:
Rituximab in combination with gemcitabine and oxaliplatin
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 18 Years and older.
2. 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.
3. 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.
4. Relapsed/refractory (R/R) DLBCL, at least one (≥1) but no more than three (≤3) line
of prior systemic therapies.
5. Patients who have not received high dose therapy/stem cell transplantation (HDT/SCT)
must be ineligible for HDT/SCT.
6. 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).
7. ECOG PS score of 0 to 2.
8. Subject must have adequate organ functions, and the laboratory values comply with
the protocol requirements.
9. Life expectancy of ≥ 3 months.
10. Informed consent before screening and can understand and comply with the
requirements of the study.
Exclusion Criteria:
1. Existing or prior history of other malignant tumor within 3 years, except for those
who have received curative treatment.
2. Current or history of central nervous system (CNS) lymphoma.
3. Known high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements.
4. Primary mediastinal B-cell lymphoma.
5. History of allogeneic stem-cell transplantation.
6. Prior exposure to anti-CD19 treatment, and (or) failed with gemcitabine plus
platinum-based agent combination therapy.
7. Current toxicity of ≥ Grade 2 from prior anti-cancer therapy (except for alopecia,
neutrophil, hemoglobin and platelets).
8. Clinically significant cardiovascular disease or nervous system disease.
9. 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.
10. Uncontrolled systemic infection requiring parenteral intravenous anti-infective
therapy.
11. Known human immunodeficiency virus (HIV), or serologic status reflecting active
hepatitis B or C infection.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Hospital
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hui Liu
Facility:
Name:
The First Hospital Of Jilin University
Address:
City:
Changchun
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ou Bai
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yajun Li
Facility:
Name:
Chenzhou No.1 People's Hospital
Address:
City:
Chaozhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xinquan Liang
Facility:
Name:
Sichuan Province People's Hospital
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Rong Xiao
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hongbin Zhang
Facility:
Name:
Guangdong General Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wenyu Li
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingqing Cai
Facility:
Name:
Hangzhou First People's Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiangmin Tong
Facility:
Name:
The First Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wenjuan Yu
Facility:
Name:
Shandong Cancer Hospital and Institute
Address:
City:
Jinan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zengjun Li
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yan Huang
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanjing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Fei Li
Facility:
Name:
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Weili Zhao
Facility:
Name:
The Second Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Bingzong Li
Facility:
Name:
Tianjin First Central Hospital
Address:
City:
Tianjin
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qi Deng
Facility:
Name:
Xinjiang Medical University Affiliated Cancer Hospital
Address:
City:
Urumqi
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shujuan Wen
Facility:
Name:
The First Affiliated Hospital Wenzhou Medical University
Address:
City:
Wenzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Songfu Jiang
Facility:
Name:
Union Hospital Tongji Medical College
Address:
City:
Wuhan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Liling Zhang
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Keshu Zhou
Start date:
May 7, 2024
Completion date:
December 2029
Lead sponsor:
Agency:
Beijing InnoCare Pharma Tech Co., Ltd.
Agency class:
Industry
Source:
Beijing InnoCare Pharma Tech Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06521255
