RecruitingPhase 3NCT06521255
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
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment
244 participants
Start Date
May 7, 2024
Study Type
INTERVENTIONAL
Conditions
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
Eligibility
Min Age: 18 Years
Inclusion Criteria10
- 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.
Exclusion Criteria11
- 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.
Interventions
DRUGRituximab
Rituximab was infused intravenously.
DRUGTafasitamab
Tafasitmab was infused intravenously
DRUGLenalidomide
Lenalidomide orally
DRUGGemcitabine
Gemcitabine was infused intravenously
DRUGOxaliplatin
Oxaliplatin was infused intravenously
Locations(20)
View Full Details on ClinicalTrials.gov
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NCT06521255
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