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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sichuan Province People's Hospital
  Chengdu, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, China Recruiting
• The Second Affiliated Hospital of Soochow University
  Suzhou, China Recruiting
• 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

Study contacts

• Study coordinator: Weili Zhao
• Email: zwl_trial@163.com
• Phone: +86 021-64370045

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL

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• Tafasitamab with lenalidomide and rituximab for newly diagnosed follicular and marginal zone lymphoma

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• Combination treatment of tafasitamab and rituximab for post-transplant lymphoma

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• Combination treatment for patients with primary central nervous system lymphoma

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  Recruiting Phase 2 University of Cologne · Stuttgart, Baden-Wurttemberg and 5 other locations · NCT05583071

• Combining Tafasitamab and Lenalidomide for treating relapsed DLBCL

  This study is testing if combining Tafasitamab and Lenalidomide can help people with relapsed or hard-to-treat Diffuse Large B-Cell Lymphoma feel better.

  Recruiting Phase 2 Beijing InnoCare Pharma Tech Co., Ltd. · Hangzhou, Zhejiang · NCT05552937

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.