Phase I/II Study of Brentuximab Vedotin and Methotrexate/ L-asparaginase/ Dexamethasone (B-MAD) Chemotherapy in Patients With Newly-diagnosed Extranodal NK/ T-cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
Study Title: Phase I/II study of brentuximab vedotin and methotrexate/ L-asparaginase/ dexamethasone (B-MAD) chemotherapy in patients with newly-diagnosed Extranodal NK/T-cell Lymphoma
Phase: I/II
Number of Patients: 36
Study Objectives
Primary
- To determine the safety and optimal dose of brentuximab vedotin when use in combination with methotrexate, L-asparaginase and dexamethasone in the treatment of newly-diagnosed ENKTL patients
Secondary
- To evaluate the clinical efficacy of this regimen
- To access the overall responses including overall response rate (ORR), disease-free survival (DSF), progression-free survival (PFS).
Overview of Study Design:
Open-label, multicenter, non-randomized, 3+3 dose escalation study of brentuximab vedotin in combination with fixed-dose MAD chemotherapy. The first cycle will be evaluated for the determination of the recommended phase II dose.
Patients will be received the treatment according to the stage of disease as follows:
- Patients with localized ENKTL (stage IE or stage IIE) will receive involved-field radiation (IRFT) with concomitant weekly intravenous Cisplatin. Three to five weeks after the completion of IFRT and cisplatin, B-MAD (Brentuximab vedotin, Methotrexate, L-asparaginase and Dexamethasone) regimen will be given every 21 days for 3 cycles.
- Patients with advanced ENKTL (stage III or stag IV) will receive B-MAD every 21 days for 6 cycles.
Study Population:
Patients with newly-diagnosed ENKTL will be screened for enrollment.
Duration of Study: 3 years
详细描述
Study Title: Phase I/II study of brentuximab vedotin and methotrexate/ L-asparaginase/ dexamethasone (B-MAD) chemotherapy in patients with newly-diagnosed Extranodal NK/T-cell Lymphoma
Phase: I/II
Number of Patients: 36
Study Objectives
Primary
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with previously untreated ENKTL as defined by the World Health Organization (WHO) classification
- •Age 18-60 years
- •Localized (stage I, II) or advanced (stage III, IV) disease
- •Adequate organ function
- •Signed informed consent
排除标准
- •Patients with other subtypes of non-Hodgkin lymphoma, including myeloid/NK cell precursor acute leukemia, blastic NK cell lymphoma/precursor NK cell lymphoblastic leukemia, aggressive NK cell leukemia, and peripheral T cell lymphoma, unspecified
- •Prior chemotherapy or radiotherapy for ENKTL
- •Seropositivity for HIV and severe infection
- •Prior or other concomitant malignant tumors
- •Pregnant or breastfeeding patients
- •Evidence of any other disease or medical conditions that contraindicate use of the study drug, or patients at high risk from treatment complications
- •Patients suffering from psychiatric disorders
研究组 & 干预措施
B-MAD chemotherapy
Brentuximab Vedotin, Methotrexate, L-Asparaginase, and Dexamethasone
干预措施: B-MAD chemotherapy (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: At the end of Cycle 1 (each cycle is 21 days)
Patients will be assessed for dose-limiting toxicity (DLT) during the first cycle. DLTs are described as follows: For non-hematologic toxicities • Any related non-hematologic events of grade 3 or higher, with the exception of: * grade 3 fatigue * grade 3 or 4 nausea and vomiting lasting than 24 hours * grade 3 non-hematologic laboratory abnormalities resolving to grade 1 or baseline within 14 days * grade 3 or 4 allergic or hypersensitivity reaction For hematologic toxicities * Related grade 4 neutropenia lasting \> 7 days * Related grade 3 febrile neutropenia requiring antibiotics * Related grade 4 febrile neutropenia * Related grade 4 thrombocytopenia
次要结局
- Disease-free survival(1 year)
- Treatment responses(At 7th week after last BV dosing)
- Progression-free survival(1 year)
研究者
Asst.Prof.Udomsak Bunworasate
A.Prof.
The Thai Lymphoma Study Group