A Phase 2, Multicenter, Open-Label Trial to Evaluate Efficacy and Safety of Subcutaneous (SC) Mosunetuzumab in Previously Untreated Low Tumor Burden Follicular Lymphoma (LTB-FL).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Primary Endpoint: Overall response rate (ORR) at the end of treatment (6 months) using the Lugano criteria
研究概览
简要总结
This is a multi-center, open-label, interventional clinical trial designed to evaluate the efficacy and safety of subcutaneous (SC) Mosunetuzumab as a first-line immunotherapy in patients with low tumor burden follicular lymphoma (LTB-FL), defined by the absence of GELF criteria.
详细描述
Eligible patients will undergo screening and, upon signing an Informed Consent Form, will receive their first dose of SC Mosunetuzumab.
Mosunetuzumab is administered via SC injection without the need for mandatory hospitalization. The first cycle lasts 21 days, followed by subsequent 21-day cycles. In Cycle 1, Mosunetuzumab is given on Day 1 (5 mg), Day 8 (45 mg), and Day 15 (45 mg). From Cycle 2 onward, a single 45 mg dose is administered on Day 1 of each cycle. Treatment continues for up to 8 cycles (approximately 6 months).
Patients will be monitored for disease status according to standard clinical practice. After completing active treatment, they will enter a post-treatment follow-up phase.
Premedication with dexamethasone (20 mg) is mandatory in Cycle 1 and optional in later cycles. Acetaminophen and diphenhydramine may also be administered.
All patients will continue study treatment as per the Schedule of Activities or until premature discontinuation. After treatment discontinuation, disease status assessments will occur approximately every 3 months for up to 24 months. During post-treatment follow-up, PET-CT scans for disease evaluation will be performed every 6 months, as applicable. Patients not under active follow-up will be contacted annually to collect data on disease status and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years old
- •Histologically confirmed classic FL (cFL) (according to WHO-HEAM4R classification)
- •Low tumor burden by GELF criteria
- •No prior therapy except surgery or radiotherapy for disease that was previously localized
- •Ann Arbor Stage III or IV disease
- •Bi-dimensionally measurable FDG-avid disease defined by at least one single node or tumor lesion > 1.5 cm assessed by CT scan and/or clinical examination
- •Adequate hematologic function defined as follows without growth factors or blood product transfusion within 14 days of first dose of study drug administration:
- •Hemoglobin, without transfusion, 9 g/dL
- •ANC 1.0 109/L
- •Platelet count 75 109/L;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- •Patient can understand and sign the Informed Consent Form (ICF), can communicate with the Investigator, can understand and comply with the requirements of the protocol
排除标准
- •1. An active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) defined by detectable viral DNA in the blood by PCR. Patients with HIV are eligible provided an undetectable viral load and a CD4 count > 200 cell/mcl
- •2. Any of the following laboratory abnormalities:
- •Total Bilirubin or GGT or AST or ALT > 3 X ULN.
- •Creatinine Clearance calculated by Cockcroft and Gault Formula < 40 ml/min
- •Presence or history of CNS involvement by lymphoma
- •4. Prior history of malignancies other than Lymphoma (except for Basal Cell or Squamous Cell Carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 2 years
- •Contraindication to use Mosunetuzumabor known sensitivity or allergy
- •Pregnant or lactating females
- •7. Female patients of childbearing potential who cannot or do not wish to use an effective method of contraception, during the study treatment and for 3 months thereafter
研究组 & 干预措施
Patients with follicular lymphoma with low tumor burden who have not been previously treated
In this study, Mosunetuzumab will be administered subcutaneously over 8 treatment cycles: 5 mg on Day 1 of Cycle 1, followed by 45 mg in all subsequent cycles.
干预措施: Mosunetuzumab is a bispecific monoclonal antibody targeting CD20 on B cells and CD3 on T cells, redirecting T cells to eliminate malignant B cells. (Drug)
结局指标
主要结局
Primary Endpoint: Overall response rate (ORR) at the end of treatment (6 months) using the Lugano criteria
时间窗: 6 months
It refers to the proportion of patients who experience a predefined reduction in tumor size as a result of treatment.
Overall Response Rate-ORR Overall response rate (ORR) at the end of treatment (6 months) using the Lugano criteria
时间窗: 6 months
ORR is defined as the proportion of patients who achieved Complete Response or Partial Response determined by Lugano 2014 criteria as assessed by investigators at 6 months after initiation of treatment and prior to the initiation of any subsequent anti-lymphoma therapy. Patients without post-baseline disease assessments will be considered non-responders.
次要结局
- 1. Incidence of adverse events (AEs) and abnormal laboratory test results from first dose through 90 days after administration of last dose;(through 90 days after administration of last dose;)
- Progression free survival (PFS), complete metabolic response rate (CRR), duration of response (DOR), duration of complete response, time to next systemic anti-lymphoma treatment (TTNT) and overall survival (OS) at 12 and 24 months(at 12 and 24 months)
- Patient reported outcomes (PROs) according to the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) subscale.(6 months (after last drug administration)
- Progression Free Survival -PFS(up to 24 months after last treatment dose)
- Overall Survival -OS(up to 24 months after last treatment dose)
- Duration of response -DOR(up to 24 months after last treatment dose)
- Complete Response Rate - CRR - Lymphoma (FACT-Lym) subscale.(up to 24 months after last treatment dose)
- Duration of Complete Response -DOCR(up to 24 months after last treatment dose)
- Time to Next Treatment -TTNT(up to 24 months after last treatment dose)
- Statistical Analysis for Safety(from first dose through 90 days after administration of last dose)
- Health related quality of life(whole treatment period- 6 months)