Clinical trial NCT06521255: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: DLBCL
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-25
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphom


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.

Primary outcomes:
measure: Dose limiting toxicity（DLT）and other adverse events (AEs) of tafasitamab and lenalidomide in combination with GemOx (TL-GemOx) assessed using CTCAE v5.0
timeFrame: within 28 days after therapy initiation
measure: PFS assessed by IRC according to Lugano 2014
timeFrame: 1-3 years approximately
Secondary outcomes:
measure: Objective Response Rate (ORR) according to investigator.
timeFrame: 1-3 years approximately
measure: Complete Response Rate (CRR) according to investigator.
timeFrame: 1-3 years approximately
measure: Duration of Response (DOR) according to investigator.
timeFrame: 1-3 years approximately
measure: Progression free survival (PFS) assessed by investigator according to the Lugano 2014
timeFrame: 1-3 years approximately
measure: Time to response (TTR)
timeFrame: 1-3 years approximately
measure: Overall Survival (OS)
timeFrame: 1-3 years approximately
measure: Time to next treatment (TTNT)
timeFrame: 1-3 years approximately
measure: Adverse events assessed by CTCAE version 5.0 criteria.
timeFrame: 1-3 years approximately
measure: Quality of life assessment: Patient-reported outcomes (PROs) on happiness and general health status based on Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
timeFrame: 1-3 years approximately
measure: Quality of life assessment: Patient-reported outcomes (PROs) on happiness and general health status based on EuroQol five dimensions questionnaire (EQ-5D-5L)
timeFrame: 1-3 years approximately
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
city: Changchun
country: China
facility: The First Hospital Of Jilin University
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chaozhou
country: China
facility: Chenzhou No.1 People's Hospital
city: Chengdu
country: China
facility: Sichuan Province People's Hospital
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
city: Tianjin
country: China
facility: Tianjin First Central Hospital
city: Urumqi
country: China
facility: Xinjiang Medical University Affiliated Cancer Hospital
city: Wenzhou
country: China
facility: The First Affiliated Hospital Wenzhou Medical University
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
References: