Clinical trial NCT06757894: Efficacy and Safety of Zuberitamab Combined with Bendamustine, Followed by Monotherapy Maintenance, in Treatment-naïve Follicular Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Follicular Lymphoma (FL)
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Gansu Cancer Hospital
name: Ganzhou Cancer Hospital
name: Fifth Affiliated Hospital, Sun Yat-Sen University
name: Fifth Affiliated Hospital of Guangzhou Medical University
First posted: 2025-01-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Complete Response (CR)
timeFrame: Up to 6 cycles (each cycle is 28 days).
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 6 cycles (each cycle is 28 days).
measure: Progression-Free Survival (PFS)
timeFrame: 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.
measure: Event-Free Survival (EFS)
timeFrame: 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.
measure: Duration of Response (DOR)
timeFrame: From the first documentation of CR or PR to the first documented disease progression, assessed up to 78 months.
measure: Overall Survival (OS)
timeFrame: From the start of induction therapy to death from any cause, assessed up to 78 months.
measure: Time to Next Treatment (TTNT)
timeFrame: From the start of induction therapy to the start of the next line of anti-tumor treatment, assessed up to 78 months.
measure: Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE)
timeFrame: From the start of induction therapy through the end of the maintenance therapy phase, up to 30 months.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
state: Guangdong
Study officials:
References: