Status:
RECRUITING
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
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
DLBCL
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 Pa...
Eligibility Criteria
Inclusion
- 18 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
- 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.
Key Trial Info
Start Date :
May 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT06521255
Start Date
May 7 2024
End Date
December 1 2029
Last Update
July 25 2024
Active Locations (20)
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1
Beijing Hospital
Beijing, China
2
The First Hospital Of Jilin University
Changchun, China
3
Hunan Cancer Hospital
Changsha, China
4
Chenzhou No.1 People's Hospital
Chaozhou, China