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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
244
Tafasitmab was infused intravenously
Lenalidomide orally
Gemcitabine was infused intravenously
Oxaliplatin was infused intravenously
Rituximab was infused intravenously.
Beijing Hospital
Beijing, China
NOT_YET_RECRUITINGThe First Hospital Of Jilin University
Changchun, China
NOT_YET_RECRUITINGHunan Cancer Hospital
Changsha, China
NOT_YET_RECRUITINGChenzhou No.1 People's Hospital
Chaozhou, China
NOT_YET_RECRUITINGSichuan Province People's Hospital
Chengdu, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, China
NOT_YET_RECRUITINGGuangdong General Hospital
Guangzhou, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, China
RECRUITINGHangzhou First People's Hospital
Hangzhou, China
NOT_YET_RECRUITINGThe First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
NOT_YET_RECRUITING...and 10 more locations
Dose limiting toxicity(DLT)and other adverse events (AEs) of tafasitamab and lenalidomide in combination with GemOx (TL-GemOx) assessed using CTCAE v5.0
Time frame: within 28 days after therapy initiation
PFS assessed by IRC according to Lugano 2014
Time frame: 1-3 years approximately
Objective Response Rate (ORR) according to investigator.
Time frame: 1-3 years approximately
Complete Response Rate (CRR) according to investigator.
Time frame: 1-3 years approximately
Duration of Response (DOR) according to investigator.
Time frame: 1-3 years approximately
Progression free survival (PFS) assessed by investigator according to the Lugano 2014
Time frame: 1-3 years approximately
Time to response (TTR)
Time frame: 1-3 years approximately
Overall Survival (OS)
Time frame: 1-3 years approximately
Time to next treatment (TTNT)
Time frame: 1-3 years approximately
Adverse events assessed by CTCAE version 5.0 criteria.
Time frame: 1-3 years approximately
Quality of life assessment: Patient-reported outcomes (PROs) on happiness and general health status based on Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
Time frame: 1-3 years approximately
Quality of life assessment: Patient-reported outcomes (PROs) on happiness and general health status based on EuroQol five dimensions questionnaire (EQ-5D-5L)
Time frame: 1-3 years approximately
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