This is a A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Tafasitamab will be administered intravenously in 28-day cycles. During Cycles 1 through 3, tafasitamab will be administered weekly on Days 1, 8, 15, and 22; an additional loading dose will be administered on Cycle 1 Day 4. Starting with Cycle 4, tafasitamab will be administered on Days 1 and 15 of each cycle. Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.
The First Afflicated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGObjective response rate (ORR)
Evaluation by the Independent Review Committee (IRC).
Time frame: 1-3 years approximately
Objective Response Rate (ORR)
Evaluated by the IRC according to cheson 2007 and cheson 2014.
Time frame: 1-3 years approximately
Disease Control Rate (DCR)
Time frame: 1-3 years approximately
Duration of Response (DOR)
Time frame: 1-3 years approximately
Progression Free Survial (PFS)
Time frame: 1-3 years approximately
Time to progression (TTP)
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
Safety of Lenalidomide combined with Tafasitamab according to the frequency and severity of adverse events (AEs).
Time frame: 2 years
Potential immunogenicity of Tafasitamab.
Time frame: 2 years
Maximum serum concentration (Cmax)
Time frame: 2 years
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Time to maximum serum concentration (tmax)
Time frame: 2 years
Apparent trough serum concentration before dosing (Cpd)
Time frame: 2 years
Area under the serum concentration versus time curve from time 0 to the time t of the last quantifiable concentration (AUC0-t)
Time frame: 2 years