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| Name | Class |
|---|---|
| Gansu Cancer Hospital | OTHER |
| Ganzhou Cancer Hospital | UNKNOWN |
| Fifth Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Fifth Affiliated Hospital of Guangzhou Medical University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zuberitamab and Bendamustine Combination Treatment | Experimental | Induction therapy:
Maintenance therapy: Zuberitamab: 375 mg/m², administered once every 2 months, until disease progression or for a maximum of 24 months (12 doses). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zuberitamab | Drug | 375 mg/m², administered on Day 1 (D1) of Cycles 1-6 (C1-C6) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The proportion of patients who achieve complete remission (CR) or partial remission (PR) at the end of induction therapy. | Up to 6 cycles (each cycle is 28 days). |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
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:
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Expected survival of > 6 months.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai, MD. PhD. | Contact | 02087342823 | caiqq@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University | Guangzhou | Guangdong | 510060 | China |
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| OTHER |
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| Bendamustine | Drug | 90 mg/m², administered on D1-2 of C1-C6 |
|
The length of time during and after treatment that a patient lives with cancer without it getting worse or progressing.
| 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. | 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. | 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. | 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. | 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. | From the start of induction therapy through the end of the maintenance therapy phase, up to 30 months. |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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