Follicular Lymphoma (FL)Phase 2NCT06757894
Efficacy and Safety of Zuberitamab Combined with Bendamustine, Followed by Monotherapy Maintenance, in Treatment-naïve Follicular Lymphoma
A Phase 2 study testing Zuberitamab and Bendamustine in people with Follicular Lymphoma (FL), run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma (FL)
- What is being tested?
- Zuberitamab and Bendamustine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 1 Feb 2034
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, 510060
Qingqing Cai, MD. PhD., 0086-20-87342823, caiqq@sysucc.org.cn
About this study
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
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)
- Being tested
- Zuberitamab, Bendamustine
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZuberitamabDrug
375 mg/m², administered on Day 1 (D1) of Cycles 1-6 (C1-C6)
BendamustineDrug
90 mg/m², administered on D1-2 of C1-C6
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Zuberitamab; Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR)
Defined as the proportion of patients who achieve complete remission at the end of induction therapy.
Measured: Up to 6 cycles (each cycle is 28 days).
Secondary outcomes (7)
Objective Response Rate (ORR)
The proportion of patients who achieve complete remission (CR) or partial remission (PR) at the end of induction therapy.
Measured: Up to 6 cycles (each cycle is 28 days).
Progression-Free Survival (PFS)
The length of time during and after treatment that a patient lives with cancer without it getting worse or progressing.
Measured: 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)
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.
Measured: 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)
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.
Measured: From the first documentation of CR or PR to the first documented disease progression, assessed up to 78 months.
Overall Survival (OS)
The length of time from the date of enrollment until death from any cause.
Measured: From the start of induction therapy to death from any cause, assessed up to 78 months.
Time to Next Treatment (TTNT)
The length of time from the initiation of a current treatment until the patient requires a subsequent line of therapy for the cancer.
Measured: From the start of induction therapy to the start of the next line of anti-tumor treatment, assessed up to 78 months.
Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE)
The occurrence and intensity of undesirable or harmful effects experienced by patients associated with the use of a medical treatment or intervention during the clinical trial.
Measured: From the start of induction therapy through the end of the maintenance therapy phase, up to 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular Lymphoma (FL)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Gansu Cancer Hospital, Ganzhou Cancer Hospital, Fifth Affiliated Hospital, Sun Yat-Sen University, Fifth Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757894
- Sponsor's protocol ID
- B2024-815-01
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06757894
- Acronym / sponsor ID
- B2024-815-01
- Conditions
- Follicular Lymphoma (FL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Gansu Cancer Hospital, Ganzhou Cancer Hospital, Fifth Affiliated Hospital, Sun Yat-Sen University, Fifth Affiliated Hospital of Guangzhou Medical University
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2034 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zuberitamab and Bendamustine Combination Treatment | Experimental | Drug: Zuberitamab, Drug: BendamustineInduction 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zuberitamab375 mg/m², administered on Day 1 (D1) of Cycles 1-6 (C1-C6) | Drug | Zuberitamab and Bendamustine Combination Treatment |
| Bendamustine90 mg/m², administered on D1-2 of C1-C6 | Drug | Zuberitamab and Bendamustine Combination Treatment |
Primary outcome
Complete Response (CR)
Time frame: Up to 6 cycles (each cycle is 28 days).
Defined as the proportion of patients who achieve complete remission at the end of induction therapy.
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 6 cycles (each cycle is 28 days).
Progression-Free Survival (PFS)
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.
Event-Free Survival (EFS)
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.
Duration of Response (DOR)
Time frame: From the first documentation of CR or PR to the first documented disease progression, assessed up to 78 months.
Overall Survival (OS)
Time frame: From the start of induction therapy to death from any cause, assessed up to 78 months.
Time to Next Treatment (TTNT)
Time frame: From the start of induction therapy to the start of the next line of anti-tumor treatment, assessed up to 78 months.
Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE)
Time frame: From the start of induction therapy through the end of the maintenance therapy phase, up to 30 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zuberitamab and Bendamustine in people with Follicular Lymphoma (FL), run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingqing Cai, MD. PhD. (02087342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) (time frame: Up to 6 cycles (each cycle is 28 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.