This is a prospective, single-arm, multicenter, phase ll clinical trial to evaluate the efficacy and safety of Zuberitamab and Bendamustine combination treatment in treatment-naïve follicular lymphoma patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
375 mg/m², administered on Day 1 (D1) of Cycles 1-6 (C1-C6)
90 mg/m², administered on D1-2 of C1-C6
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, China
Complete Response (CR)
Defined as the proportion of patients who achieve complete remission at the end of induction therapy.
Time frame: Up to 6 cycles (each cycle is 28 days).
Objective Response Rate (ORR)
The proportion of patients who achieve complete remission (CR) or partial remission (PR) at the end of induction therapy.
Time frame: Up to 6 cycles (each cycle is 28 days).
Progression-Free Survival (PFS)
The length of time during and after treatment that a patient lives with cancer without it getting worse or progressing.
Time frame: From the start of induction therapy to the first documented disease progression or death from any cause, whichever occurs first, assessed up to 78 months.
Event-Free Survival (EFS)
The length of time during and after treatment during which a patient remains free from any of the following events: disease progression, treatment discontinuation for any reason, or death from any cause.
Time frame: From the start of induction therapy to the first occurrence of any event, including disease progression, discontinuation of treatment, or death for any reason, whichever occurs first, assessed up to 78 months.
Duration of Response (DOR)
The length of time during and after treatment that a patient's disease remains under control or in remission. It is the period from the first documentation of a response (such as partial or complete remission) until disease progression or relapse occurs.
Time frame: From the first documentation of CR or PR to the first documented disease progression, assessed up to 78 months.
Overall Survival (OS)
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The length of time from the date of enrollment until death from any cause.
Time frame: From the start of induction therapy to death from any cause, assessed up to 78 months.
Time to Next Treatment (TTNT)
The length of time from the initiation of a current treatment until the patient requires a subsequent line of therapy for the cancer.
Time frame: From the start of induction therapy to the start of the next line of anti-tumor treatment, assessed up to 78 months.
Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE)
The occurrence and intensity of undesirable or harmful effects experienced by patients associated with the use of a medical treatment or intervention during the clinical trial.
Time frame: From the start of induction therapy through the end of the maintenance therapy phase, up to 30 months.