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

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

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

Study Overview

• Status: Recruiting
• Conditions: DLBCL
• Intervention / Treatment: Drug: Tafasitamab; Drug: Lenalidomide; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Rituximab

• Study Type: Interventional
• Enrollment (Estimated): 244
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Weili Zhao; Phone Number: +86 021-64370045; Email: zwl_trial@163.com

Study Locations

• China
  • Beijing, China
    • Not yet recruiting
    • Beijing Hospital
    • Contact: Hui Liu
  • Changchun, China
    • Not yet recruiting
    • The First Hospital of Jilin University
    • Contact: Ou Bai
  • Changsha, China
    • Not yet recruiting
    • Hunan Cancer Hospital
    • Contact: Yajun Li
  • Chaozhou, China
    • Not yet recruiting
    • Chenzhou No.1 People's Hospital
    • Contact: Xinquan Liang
  • Chengdu, China
    • Recruiting
    • Sichuan Province People's Hospital
    • Contact: Rong Xiao
  • Chongqing, China
    • Not yet recruiting
    • The First Affiliated Hospital of Chongqing Medical University
    • Contact: Hongbin Zhang
  • Guangzhou, China
    • Recruiting
    • Sun Yat-sen University Cancer Center
    • Contact: Qingqing Cai
  • Guangzhou, China
    • Not yet recruiting
    • Guangdong General Hospital
    • Contact: Wenyu Li
  • Hangzhou, China
    • Not yet recruiting
    • The first Affiliated Hospital, Zhejiang University School of Medicine
    • Contact: Wenjuan Yu
  • Hangzhou, China
    • Not yet recruiting
    • Hangzhou First People's Hospital
    • Contact: Xiangmin Tong
  • Jinan, China
    • Not yet recruiting
    • Shandong Cancer Hospital and Institute
    • Contact: Zengjun Li
  • Nanchang, China
    • Not yet recruiting
    • Jiangxi Cancer Hospital
    • Contact: Yan Huang
  • Nanjing, China
    • Not yet recruiting
    • The First Affiliated Hospital of NanChang University
    • Contact: Fei Li
  • Shanghai, China
    • Not yet recruiting
    • Ruijin Hospital Shanghai Jiaotong University School of Medicine
    • Contact: Weili Zhao
  • Suzhou, China
    • Recruiting
    • The Second Affiliated Hospital of Soochow University
    • Contact: Bingzong Li
  • Tianjin, China
    • Not yet recruiting
    • Tianjin First Central Hospital
    • Contact: Qi Deng
  • Urumqi, China
    • Not yet recruiting
    • Xinjiang Medical University Affiliated Cancer Hospital
    • Contact: Shujuan Wen
  • Wenzhou, China
    • Not yet recruiting
    • The First Affiliated Hospital Wenzhou Medical University
    • Contact: Songfu Jiang
  • Wuhan, China
    • Not yet recruiting
    • Union Hospital Tongji Medical College
    • Contact: Liling Zhang
  • Zhengzhou, China
    • Not yet recruiting
    • Henan Cancer Hospital
    • Contact: Keshu Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin	Drug: Tafasitamab; Tafasitmab was infused intravenously; Drug: Lenalidomide; Lenalidomide orally; Drug: Gemcitabine; Gemcitabine was infused intravenously; Drug: Oxaliplatin; Oxaliplatin was infused intravenously
Active Comparator: Rituximab in combination with gemcitabine and oxaliplatin	Drug: Gemcitabine; Gemcitabine was infused intravenously; Drug: Oxaliplatin; Oxaliplatin was infused intravenously; Drug: Rituximab; Rituximab was infused intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Time to response (TTR)	1-3 years approximately
Overall Survival (OS)	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
Duration of Response (DOR) 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
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
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

Collaborators and Investigators

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide; Oxaliplatin; Rituximab; Gemcitabine
• Other Study ID Numbers: ICP-CL-00903

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No