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

Launched by BEIJING INNOCARE PHARMA TECH CO., LTD. · Jul 24, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatment combinations for patients with a type of blood cancer called relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study is comparing a combination of four drugs: Tafasitamab and Lenalidomide along with Gemcitabine and Oxaliplatin, against another combination that includes Rituximab with Gemcitabine and Oxaliplatin. The goal is to see which combination is safer and more effective for patients whose cancer has come back or has not responded to previous treatments.

To be eligible for the trial, participants must be at least 18 years old and have a confirmed diagnosis of DLBCL. They should have had at least one prior treatment but no more than three. Participants must also have measurable disease, meaning their cancer can be seen on imaging tests, and must be well enough overall to take part in the study. If you or someone you know is considering this trial, they can expect close monitoring by doctors and regular check-ups throughout the study to assess how well the treatments work and manage any side effects. Remember, it's important to talk to a healthcare provider to understand all the details and make the best decision.

Gender

ALL

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.