Health TrialsbyHealthPanel

Efficacy and Safety of Zuberitamab Combined with Bendamustine, Followed by Monotherapy Maintenance, in Treatment-naïve Follicular Lymphoma

ConditionFollicular Lymphoma (FL)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary signing of informed consent.

Age ≥ 18 years, no gender restriction.

Histologically confirmed follicular lymphoma (grades 1-3a), CD20 positive by immunohistochemistry.

No prior systemic treatment for FL.

Disqualifiers

History of allergy to any component of monoclonal antibodies or investigational drugs.

Central nervous system involvement.

History of previous malignant tumors.

Clinically significant cardiac or pulmonary diseases.

Trial design

Design model

Single group

Treatments tested in this trial

  • Zuberitamab

    Drug

    375 mg/m², administered on Day 1 (D1) of Cycles 1-6 (C1-C6)

  • Bendamustine

    Drug

    90 mg/m², administered on D1-2 of C1-C6

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Zuberitamab and Bendamustine Combination TreatmentExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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).

Secondary outcomes

1

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).
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Gansu Cancer Hospital

Collaborator

Ganzhou Cancer Hospital

Collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

Collaborator

Fifth Affiliated Hospital of Guangzhou Medical University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: