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

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Hospital
NOT_YET_RECRUITING
Beijing
The First Hospital Of Jilin University
NOT_YET_RECRUITING
Changchun
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Chenzhou No.1 People's Hospital
NOT_YET_RECRUITING
Chaozhou
Sichuan Province People's Hospital
RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
Guangdong General Hospital
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Hangzhou First People's Hospital
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Shandong Cancer Hospital and Institute
NOT_YET_RECRUITING
Jinan
Jiangxi Cancer Hospital
NOT_YET_RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanjing
Ruijin Hospital Shanghai Jiaotong University School of Medicine
NOT_YET_RECRUITING
Shanghai
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Tianjin First Central Hospital
NOT_YET_RECRUITING
Tianjin
Xinjiang Medical University Affiliated Cancer Hospital
NOT_YET_RECRUITING
Ürümqi
The First Affiliated Hospital Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Union Hospital Tongji Medical College
NOT_YET_RECRUITING
Wuhan
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Weili Zhao
zwl_trial@163.com
+86 021-64370045
Time Frame
Start Date: 2024-05-07
Estimated Completion Date: 2029-12
Participants
Target number of participants: 244
Treatments
Experimental: Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin
Active_comparator: Rituximab in combination with gemcitabine and oxaliplatin
Sponsors
Leads: Beijing InnoCare Pharma Tech Co., Ltd.

This content was sourced from clinicaltrials.gov

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