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

NCT ID: NCT06757894

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2034-02-01

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zuberitamab and Bendamustine Combination Treatment

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).

Group Type: EXPERIMENTAL

Zuberitamab

Intervention Type: DRUG

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

Bendamustine

Intervention Type: DRUG

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

Interventions

Zuberitamab

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

Intervention Type: DRUG

Bendamustine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntary signing of informed consent.

2. Age ≥ 18 years, no gender restriction.

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

4. No prior systemic treatment for FL.

5. Ann Arbor stage III/IV, or stage II with bulky disease (bulky disease defined as a tumor diameter ≥ 7 cm).

6. Presence of measurable lesions.

7. Meeting any of the following criteria:

1. B symptoms: unexplained fever >38°C, night sweats, unexplained weight loss >10% in the last 6 months.

2. Abnormal signs: splenomegaly, pleural effusion, ascites, etc.

3. Major organ damage: involvement of major organs leading to organ dysfunction.

4. 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.

5. 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).

6. Tumor enlargement of 20%-30% within 2-3 months, or approximately 50% enlargement within 6 months.

8. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

9. Expected survival of > 6 months.

Exclusion Criteria

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

2. Central nervous system involvement.

3. History of previous malignant tumors.

4. Clinically significant cardiac or pulmonary diseases.

5. 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.

6. Major surgery within 4 weeks prior to enrollment.

7. Vaccination with live vaccines within 4 weeks prior to enrollment or planned live vaccination during the study.

8. HIV antibody positive.

9. Active syphilis infection, TP antibody positive, and anti-TP treatment within the last 2 years.

10. 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).

11. Pregnant or breastfeeding women, or planning to become pregnant during the study.

12. Investigator determines the patient is unsuitable for enrollment or may not be able to complete the trial for other reasons.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gansu Cancer Hospital

OTHER

Sponsor Role: collaborator

Ganzhou Cancer Hospital

UNKNOWN

Sponsor Role: collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Fifth Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Qingqing Cai

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Qingqing Cai, MD. PhD.

Role: CONTACT

caiqq@sysucc.org.cn

02087342823

Facility Contacts

Qingqing Cai, MD. PhD.

Role: primary

caiqq@sysucc.org.cn

0086-20-87342823

Other Identifiers

B2024-815-01

Identifier Type: -

Identifier Source: org_study_id