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Efficacy and Safety of Zuberitamab Combined with Bendamustine, Followed by Monotherapy Maintenance, in Treatment-naïve Follicular Lymphoma | Clinical Trials | Clareo Health

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

Efficacy and Safety of Zuberitamab and Bendamustine Combination Treatment Followed by Monotherapy Maintenance in Treatment-naïve Follicular Lymphoma: an Open-label, Prospective, Multicenter, Single-arm Phase II Clinical Study

NCT06757894•Sun Yat-sen University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

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).
+2 more criteria

Locations (1)

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

Guangzhou, Guangdong, China

Key Dates

Start Date

February 1, 2025

Primary Completion Date

February 1, 2028

Completion Date

February 1, 2034

Last Updated

January 3, 2025

Enrollment

ESTIMATED participants

Conditions

Follicular Lymphoma (FL)

Interventions

Zuberitamab

DRUG

Bendamustine

DRUG

Contacts

Qingqing Cai, MD. PhD.

CONTACT

02087342823 caiqq@sysucc.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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