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

NCT06521255 | Recruiting Phase 3

• 1 other identifier: ICP-CL-00903
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 20

Brief 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

Conditions

DLBCL

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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 response (TTR)

  1-3 years approximately

Study Arms (2)

Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin

EXPERIMENTAL

Drug: Tafasitamab; Drug: Lenalidomide; Drug: Gemcitabine; Drug: Oxaliplatin

Rituximab in combination with gemcitabine and oxaliplatin

ACTIVE COMPARATOR

Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Rituximab

Interventions

Tafasitamab DRUG

Tafasitmab was infused intravenously

Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin

Lenalidomide DRUG

Lenalidomide orally

Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin

Gemcitabine DRUG

Gemcitabine was infused intravenously

Rituximab in combination with gemcitabine and oxaliplatin; Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin

Oxaliplatin DRUG

Oxaliplatin was infused intravenously

Rituximab in combination with gemcitabine and oxaliplatin; Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin

Rituximab DRUG

Rituximab was infused intravenously.

Rituximab in combination with gemcitabine and oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (20)

Beijing Hospital

Beijing, China

NOT YET RECRUITING

The First Hospital Of Jilin University

Changchun, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, China

NOT YET RECRUITING

Chenzhou No.1 People's Hospital

Chaozhou, China

NOT YET RECRUITING

Sichuan Province People's Hospital

Chengdu, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

NOT YET RECRUITING

Guangdong General Hospital

Guangzhou, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, China

RECRUITING

Hangzhou First People's Hospital

Hangzhou, China

NOT YET RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

NOT YET RECRUITING

Shandong Cancer Hospital and Institute

Jinan, China

NOT YET RECRUITING

Jiangxi Cancer Hospital

Nanchang, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanjing, China

NOT YET RECRUITING

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, China

NOT YET RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, China

RECRUITING

Tianjin First Central Hospital

Tianjin, China

NOT YET RECRUITING

Xinjiang Medical University Affiliated Cancer Hospital

Ürümqi, China

NOT YET RECRUITING

The First Affiliated Hospital Wenzhou Medical University

Wenzhou, China

NOT YET RECRUITING

Union Hospital Tongji Medical College

Wuhan, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, China

NOT YET RECRUITING

MeSH Terms

Interventions

tafasitamab; Lenalidomide; Gemcitabine; Oxaliplatin; Rituximab

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Coordination Complexes; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Weili Zhao

CONTACT

+86 021-64370045; zwl_trial@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 25, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 25, 2024

Record last verified: 2024-06

Locations

CN (20)