Combining Tafasitamab and Lenalidomide with Gemcitabine and Oxaliplatin for treating relapsed DLBCL

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 study is testing a new combination of medications for people with relapsed DLBCL to see if it works better than the standard treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 244 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Tafasitamab, Rituximab
• Locations: 20 sites (Beijing and 19 other locations)
• Trial ID: NCT06521255 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a combination treatment involving Tafasitamab and Lenalidomide alongside Gemcitabine and Oxaliplatin, compared to Rituximab with the same chemotherapy agents in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). It is a randomized, multi-center Phase 3 study designed to determine which treatment regimen is more effective for this patient population. Participants will be monitored for their response to treatment and any adverse effects experienced during the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed relapsed or refractory DLBCL who have received one to three prior systemic therapies.

Not a fit: Patients who have undergone high dose therapy or stem cell transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with relapsed or refractory DLBCL.

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating DLBCL, suggesting potential for success in this approach.

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.

Where this trial is running

Beijing and 19 other locations

• 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)

Study contacts

• Study coordinator: Weili Zhao

Conditions DLBCL