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

Recruiting now · Phase 3

Conditions studied: DLBCL

In brief

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

Key facts

Study ID

NCT06521255

Run by

Beijing InnoCare Pharma Tech Co., Ltd.

People needed

244

Starts

2024-05-07

Expected to finish

2029-12-01

Last updated by the study team

2024-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Second Affiliated Hospital of Soochow University — Suzhou, China (enrolling)
• Sichuan Province People's Hospital — Chengdu, China (enrolling)
• Sun Yat-sen University Cancer Center — Guangzhou, China (enrolling)
• Chenzhou No.1 People's Hospital — Chaozhou, China
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, China
• Guangdong General Hospital — Guangzhou, China
• Hangzhou First People's Hospital — Hangzhou, China
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, China
• Shandong Cancer Hospital and Institute — Jinan, China
• Jiangxi Cancer Hospital — Nanchang, China
• The First Affiliated Hospital of Nanchang University — Nanjing, China
• Ruijin Hospital Shanghai Jiaotong University School of Medicine — Shanghai, China
• Tianjin First Central Hospital — Tianjin, China
• Xinjiang Medical University Affiliated Cancer Hospital — Ürümqi, China
• The First Affiliated Hospital Wenzhou Medical University — Wenzhou, China
• Union Hospital Tongji Medical College — Wuhan, China
• Beijing Hospital — Beijing, China
• Henan Cancer Hospital — Zhengzhou, China
• The First Hospital Of Jilin University — Changchun, China
• Hunan Cancer Hospital — Changsha, China

Full record on ClinicalTrials.gov

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