A Pilot Phase II Study To Assess The Efficacy Of Brentuximab Vedotin Administered Sequentially With ABVD Chemotherapy In Patients With Untreated Hodgkin Lymphoma.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Number of Participants with Complete Metabolic Response by FDG-PET
研究概览
简要总结
The purpose of this study is to assess the efficacy of two three-weekly 1.8 mg/kg Brentuximab vedotin administrations in untreated patients with Hodgkin Lymphoma (HL).
详细描述
This is a multicenter pilot phase II trial assessing 2 administrations of Brentuximab vedotin followed by PET scan and subsequent standard treatment with ABVD ± Radiotherapy. 12 patients defined by inclusion and exclusion criteria will be enrolled in one year. All subjects will be followed for disease evaluation every 3 months for one year after end of therapy until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study. For all study procedures patient will be assigned a Unique Subject Identifier (SID) number that will be used to identify the subject during the screening process and throughout study participation. A master log will be maintained of all consented subjects and will document all screening failures (i.e. subjects who are consented but do not meet study eligibility criteria). Study records such as case report forms (CRFs) may be maintained electronically and require the same security and confidentiality as paper. Clinical information will not be released without written permission of the subject/legal representative, except as specified in the informed consent form
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
- 8 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously-untreated patients with classical Hodgkin Lymphoma according to the World Health Organisation (WHO) classification
- •Histologically confirmed CD30+ HL
- •Stage IA, IIA, IIIA
- •Absence of bulky disease
- •FDG-PET at baseline
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- •Life expectancy > 6 months.
- •Age 18-70 years.
- •Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
- •Females of childbearing potential must have a negative pregnancy test result within three days of enrollment. All patients must agree to use effective contraceptive methods (one for male and two for female) during the course of the study and for 6 months following the end of full treatment (Brentuximab vedotin + ABVD +/- Radiotherapy).
- •Written informed consent.
- •Required baseline laboratory data:
- •Absolute neutrophil count ≥ 1000/μl Platelet count ≥ 50.000/ μl Serum bilirubin ≤ 1.5 times ULN Serum creatinine ≤ 1.5 times ULN Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN
排除标准
- •Peripheral neuropathy > Grade 1
- •Histologic diagnosis different from Hodgkin Lymphoma
- •Compressive symptoms
- •Patients previously treated with any anti-CD30 antibody
- •Known human immunodeficiency virus (HIV) positive
- •Known hepatitis B surface antigen-positive, or known or suspected infection active hepatitis C
- •Patients with signs or symptoms of progressive multifocal leukoencephalopathy (PML)
- •Patients with known cerebral/meningeal disease.
研究组 & 干预措施
BV-ABVD
Treatment will consist of two three-weekly doses of Brentuximab vedotin, followed by standard treatment, ABVD (3 o 6 cycles q4w).
干预措施: Brentuximab vedotin (Drug)
BV-ABVD
Treatment will consist of two three-weekly doses of Brentuximab vedotin, followed by standard treatment, ABVD (3 o 6 cycles q4w).
干预措施: ABVD (Drug)
结局指标
主要结局
Number of Participants with Complete Metabolic Response by FDG-PET
时间窗: between day +8 and day +15 from second administration of Brentuximab
Complete Metabolic Response will be defined by Deauville score 1, 2, 3.
次要结局
- Progression Free Survival (PFS)(at 1 year from the end of full treatment program.)
- Number of Participants with Adverse Events(from C1D1 of Brentuximab vedotin up to 1 year from the end of full treatment program.)
- Overall Response Rate (ORR)(Up to 4 weeks from the end of full treatment program.)
研究者
Massimo Federico, MD
Full Professor
University of Modena and Reggio Emilia