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

NCT06757894 | Not Yet Recruiting Phase 2

• 1 other identifier: B2024-815-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Follicular Lymphoma (FL)

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR)

  Defined as the proportion of patients who achieve complete remission at the end of induction therapy.

  Up to 6 cycles (each cycle is 28 days).

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  Up to 6 cycles (each cycle is 28 days).

• Progression-Free Survival (PFS)

  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)

  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)

  From the first documentation of CR or PR to the first documented disease progression, assessed up to 78 months.

• Overall Survival (OS)

  From the start of induction therapy to death from any cause, assessed up to 78 months.

Study Arms (1)

Zuberitamab and Bendamustine Combination Treatment

EXPERIMENTAL

Induction therapy: 1. Zuberitamab: 375 mg/m², administered on Day 1 (D1) of Cycles 1-6 (C1-C6). 2. Bendamustine: 90 mg/m², administered on D1-2 of C1-C6. Each cycle lasts 28 days. After 6 cycles of treatment, patients who achieve complete remission (CR) or partial remission (PR) will continue with maintenance therapy. Maintenance therapy: Zuberitamab: 375 mg/m², administered once every 2 months, until disease progression or for a maximum of 24 months (12 doses).

Drug: Zuberitamab; Drug: Bendamustine

Interventions

Zuberitamab DRUG

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

Zuberitamab and Bendamustine Combination Treatment

Bendamustine DRUG

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

Zuberitamab and Bendamustine Combination Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Ann Arbor stage III/IV, or stage II with bulky disease (bulky disease defined as a tumor diameter ≥ 7 cm).
• Presence of measurable lesions.
• Meeting any of the following criteria:
• B symptoms: unexplained fever \>38°C, night sweats, unexplained weight loss \>10% in the last 6 months.
• Abnormal signs: splenomegaly, pleural effusion, ascites, etc.
• Major organ damage: involvement of major organs leading to organ dysfunction.
• Hematologic involvement: cytopenia \[WBC \< 1.0 × 10⁹/L and/or PLT \< 100 × 10⁹/L\]; leukemia-like manifestations (malignant cells \> 5.0 × 10⁹/L); elevated LDH levels; HGB \< 120 g/L; β2-microglobulin ≥ 3 mg/L.
• Bulky disease: involvement of ≥ 3 tumors with each diameter ≥ 3 cm, or any lymph node or extranodal tumor with diameter ≥ 7 cm (for Ann Arbor stage III-IV patients).
• Tumor enlargement of 20%-30% within 2-3 months, or approximately 50% enlargement within 6 months.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Expected survival of \> 6 months.

You may not qualify if:

• 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.
• Infection requiring intravenous antibiotic treatment or hospitalization within 4 weeks prior to enrollment; or infection requiring oral antibiotics within 2 weeks prior to enrollment; or symptoms related to an infection within 1 week prior to enrollment.
• Major surgery within 4 weeks prior to enrollment.
• Vaccination with live vaccines within 4 weeks prior to enrollment or planned live vaccination during the study.
• HIV antibody positive.
• Active syphilis infection, TP antibody positive, and anti-TP treatment within the last 2 years.
• Hepatitis C virus (HCV) antibody positive with HCV RNA quantitative test result exceeding the detection limit; Hepatitis B surface antigen (HBsAg) positive or Hepatitis B core antibody (HBcAb) positive, with Hepatitis B virus DNA quantitative test result exceeding the detection limit (for patients with HBsAg or HBcAb positive status, regardless of HBV-DNA detection, oral entecavir or other antiviral therapy must be initiated prior to enrollment and continued according to the physician's instructions during the trial).
• Pregnant or breastfeeding women, or planning to become pregnant during the study.
• Investigator determines the patient is unsuitable for enrollment or may not be able to complete the trial for other reasons.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Gansu Cancer Hospital: collaborator
• Ganzhou Cancer Hospital: collaborator
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator
• Fifth Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Qingqing Cai, MD. PhD.

CONTACT

02087342823; caiqq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 3, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2034
• Last Updated: January 3, 2025

Record last verified: 2024-12

Locations

CN (1)