NCT02298283已完成2 期
Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II Hodgkin's Lymphoma and FDG-PET Positivity After 2 Cycles of ABVD
The Lymphoma Academic Research Organisation30 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 30
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin's lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).
详细描述
This study aims to evaluate the progression free survival after treatment for patient with stage I/II supradiaphragmatic HL patient and PET positive after 2 courses of ABVD.
The treatment consist of 3 phases :
- induction treatment with 2 cycles every 3 weeks of bleomycin, etoposide, Adriamycin, cyclophosphamide, oncovin, procarbazine, and prednisone (BEACOPP) escalated
- radiotherapy 30 Gy starting 3 to 4 weeks after last day of second course of BEACOPP-escalated
- consolidation treatment with 8 cycles every 21 days of brentuximab vedotin
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed cluster of differentiation antigen 30+ (CD30+) classical Hodgkin lymphoma
- •Patients must have provided voluntary written informed consent
- •Supradiaphragmatic Ann Arbor clinical stage I or II
- •Mandatory PET scan performed at diagnosis
- •Patients treated with first-line ABVD and PET scan positive after 2 cycles (Deauville score 4 & 5)
- •Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Life expectancy > 6 months
- •Patients must be 18-65 years of age
- •Patients must be available for periodic blood sampling, study-related assessments and management of toxicity at the treating institution
- •Female patients who:
- •Are postmenopausal for at least 1 year before the screening visit OR are surgically sterile OR
- •If they are of childbearing potential, agree to practice 2 effective methods of contraception at the same time
- •Male patients, even if surgically sterilized, who agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse
- •Clinical laboratory values as specified below before the first dose of study drug:
- •Absolute neutrophil count ≥ 1,500/µL
- •Platelet count ≥ 75,000/ µL
- •Total bilirubin must be < 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)must be < 3 x the upper limit of the normal range
- •Serum creatinine must be < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute
- •Hemoglobin must be ≥ 8g/dL
- •Patient affiliated to social security system
排除标准
- •Patients with dementia or altered mental status that would preclude compliance with drug delivery
- •Women who are pregnant or breastfeeding
- •Patients with symptomatic pulmonary disease
- •Patients with known history of any of the following cardiovascular conditions:
- •Myocardial infarction within 2 years of inclusion
- •New York Heart Association (NYHA) Class III or IV heart failure
- •Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- •Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%
- •Any history of cancer or cancer treatment during the last 3 years with the exception of non-melanoma skin cancer or stage 0 (in situ) carcinoma of any type if they have undergone complete resection
- •Uncontrolled infectious disease, including active Hepatitis B Virus (HBV) infection defined by either detection of Hepatitis B surface (HBs) Antigen or presence of Hepatitis B core (HBc) antibody without detectable anti HBs antibody
- •Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics at the time of inclusion and planned to be still on going within 2 weeks prior to first study drug dose
- •Known Human Immunodeficiency Virus (HIV), known or suspected hepatitis C Virus (HCV) or human T-cell lymphotrophic virus (HTLV) serology positivity
- •Patients who have been treated previously with any anti-CD30 antibody
- •Known hypersensitivity to any excipients contained in the brentuximab vedotin formulation
- •Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencephalopathy (PML)
- •Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
- •Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment
研究组 & 干预措施
study treatment
Experimental
- induction = BEACOPP-escalated (bleomycin, etoposide, adriamycin, cyclophosphamide, oncovin, procarbazine, and prednisone) : 2 cycles every 3 weeks
- radiotherapy = involved field radiotherapy (IFRT) will be given 3 to 4 weeks after the last day of second BEACOPP at 30 Grays (+boost 6 Grays to area with residual lesion) in 3 weeks
- Consolidation = brentuximab vedotin treatment will start 4 weeks after the last day of IFRT and up to 6 weeks. The dose of study treatment is 1.8 mg/kg
干预措施: brentuximab vedotin (Drug)
study treatment
Experimental
- induction = BEACOPP-escalated (bleomycin, etoposide, adriamycin, cyclophosphamide, oncovin, procarbazine, and prednisone) : 2 cycles every 3 weeks
- radiotherapy = involved field radiotherapy (IFRT) will be given 3 to 4 weeks after the last day of second BEACOPP at 30 Grays (+boost 6 Grays to area with residual lesion) in 3 weeks
- Consolidation = brentuximab vedotin treatment will start 4 weeks after the last day of IFRT and up to 6 weeks. The dose of study treatment is 1.8 mg/kg
干预措施: Cyclophosphamide (Drug)
study treatment
Experimental
- induction = BEACOPP-escalated (bleomycin, etoposide, adriamycin, cyclophosphamide, oncovin, procarbazine, and prednisone) : 2 cycles every 3 weeks
- radiotherapy = involved field radiotherapy (IFRT) will be given 3 to 4 weeks after the last day of second BEACOPP at 30 Grays (+boost 6 Grays to area with residual lesion) in 3 weeks
- Consolidation = brentuximab vedotin treatment will start 4 weeks after the last day of IFRT and up to 6 weeks. The dose of study treatment is 1.8 mg/kg
干预措施: Adriamycin (Drug)
study treatment
Experimental
- induction = BEACOPP-escalated (bleomycin, etoposide, adriamycin, cyclophosphamide, oncovin, procarbazine, and prednisone) : 2 cycles every 3 weeks
- radiotherapy = involved field radiotherapy (IFRT) will be given 3 to 4 weeks after the last day of second BEACOPP at 30 Grays (+boost 6 Grays to area with residual lesion) in 3 weeks
- Consolidation = brentuximab vedotin treatment will start 4 weeks after the last day of IFRT and up to 6 weeks. The dose of study treatment is 1.8 mg/kg
干预措施: Oncovin (Drug)
study treatment
Experimental
- induction = BEACOPP-escalated (bleomycin, etoposide, adriamycin, cyclophosphamide, oncovin, procarbazine, and prednisone) : 2 cycles every 3 weeks
- radiotherapy = involved field radiotherapy (IFRT) will be given 3 to 4 weeks after the last day of second BEACOPP at 30 Grays (+boost 6 Grays to area with residual lesion) in 3 weeks
- Consolidation = brentuximab vedotin treatment will start 4 weeks after the last day of IFRT and up to 6 weeks. The dose of study treatment is 1.8 mg/kg
干预措施: Bleomycin (Drug)
study treatment
Experimental
- induction = BEACOPP-escalated (bleomycin, etoposide, adriamycin, cyclophosphamide, oncovin, procarbazine, and prednisone) : 2 cycles every 3 weeks
- radiotherapy = involved field radiotherapy (IFRT) will be given 3 to 4 weeks after the last day of second BEACOPP at 30 Grays (+boost 6 Grays to area with residual lesion) in 3 weeks
- Consolidation = brentuximab vedotin treatment will start 4 weeks after the last day of IFRT and up to 6 weeks. The dose of study treatment is 1.8 mg/kg
干预措施: Etoposide (Drug)
study treatment
Experimental
- induction = BEACOPP-escalated (bleomycin, etoposide, adriamycin, cyclophosphamide, oncovin, procarbazine, and prednisone) : 2 cycles every 3 weeks
- radiotherapy = involved field radiotherapy (IFRT) will be given 3 to 4 weeks after the last day of second BEACOPP at 30 Grays (+boost 6 Grays to area with residual lesion) in 3 weeks
- Consolidation = brentuximab vedotin treatment will start 4 weeks after the last day of IFRT and up to 6 weeks. The dose of study treatment is 1.8 mg/kg
干预措施: Procarbazine (Drug)
study treatment
Experimental
- induction = BEACOPP-escalated (bleomycin, etoposide, adriamycin, cyclophosphamide, oncovin, procarbazine, and prednisone) : 2 cycles every 3 weeks
- radiotherapy = involved field radiotherapy (IFRT) will be given 3 to 4 weeks after the last day of second BEACOPP at 30 Grays (+boost 6 Grays to area with residual lesion) in 3 weeks
- Consolidation = brentuximab vedotin treatment will start 4 weeks after the last day of IFRT and up to 6 weeks. The dose of study treatment is 1.8 mg/kg
干预措施: Prednisone (Drug)
study treatment
Experimental
- induction = BEACOPP-escalated (bleomycin, etoposide, adriamycin, cyclophosphamide, oncovin, procarbazine, and prednisone) : 2 cycles every 3 weeks
- radiotherapy = involved field radiotherapy (IFRT) will be given 3 to 4 weeks after the last day of second BEACOPP at 30 Grays (+boost 6 Grays to area with residual lesion) in 3 weeks
- Consolidation = brentuximab vedotin treatment will start 4 weeks after the last day of IFRT and up to 6 weeks. The dose of study treatment is 1.8 mg/kg
干预措施: G-CSF (Drug)
study treatment
Experimental
- induction = BEACOPP-escalated (bleomycin, etoposide, adriamycin, cyclophosphamide, oncovin, procarbazine, and prednisone) : 2 cycles every 3 weeks
- radiotherapy = involved field radiotherapy (IFRT) will be given 3 to 4 weeks after the last day of second BEACOPP at 30 Grays (+boost 6 Grays to area with residual lesion) in 3 weeks
- Consolidation = brentuximab vedotin treatment will start 4 weeks after the last day of IFRT and up to 6 weeks. The dose of study treatment is 1.8 mg/kg
干预措施: 30 Grays (Radiation)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 2 years
PFS is defined as the time from the date of the first cycle of ABVD to the first observation of documented disease progression or death due to any cause.
次要结局
- Overall survival(4 years)
- Complete Response rate (CR rate)(35 weeks)
研究者
研究点 (30)
Loading locations...
相似试验
进行中（未招募）
1 期
Study of the efficiency of brentuximab vedotin in the Hodgkin lymphoma treatment for the patients not cured by standard chemotherapy.EUCTR2013-000734-35-FRYSARC40
进行中（未招募）
1 期
Study of the efficiency of brentuximab vedotin in the Hodgkin lymphoma treatment for the patients not cured by standard chemotherapy.Patients aged from 18 to 70 years with supradiaphragmatic Ann Arbor clinical stage I or II classical Hodgkin lymphoma CD30+, FDG-PET positive score 4 & 5 according to Deauville criteria after 2 courses of ABVD will be included in the trial.MedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-000734-35-BEYSARC40
进行中（未招募）
1 期
A trial to improve disease control after an allogeneic stem cell transplantation for relapsed or refractory classical Hodgkin lymphoma with consolidation therapy by Brentuximab VedotiEUCTR2018-000873-59-DEniversity of Cologne21
已完成
1 期
Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin LymphomaHodgkin DiseaseNCT01874054Seagen Inc.55
已完成
2 期
Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin LymphomaClassical Hodgkin LymphomaNCT03652441University of Cologne14