EUCTR2016-002509-21-IT进行中（未招募）1 期
A randomized, open-label, multicenter, phase III, 2-arm study comparing efficacy and tolerability of the intensified variant ‘dose-dense/dose-intense ABVD’ (ABVD DD-DI) with an interim PET response-adapted ABVD program as upfront therapy in advanced-stage classical Hodgkin Lymphoma (HL). - FIL-Rouge
FONDAZIONE ITALIANA LINFOMI ONLUS0 个研究点目标入组 500 人开始时间: 2021年6月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Histologically confirmed classical HL;
- •- Previously untreated disease;
- •- Age 18-60 years;
- •- Ann Arbor stage IIB with extranodal involvement
- •and/or mediastinal bulk, III and IV (Appendix A);
- •- At least one target PET-avid bidimensionally assessable lesion;
- •- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ¿2 (Appendix B);
- •- Adequate organ and marrow function as defined below: absolute neutrophil count >1,0 x10^9/L; platelets >75 x10^9/L;
- •- Total bilirubin <2 mg/dl without a pattern consistent with Gilbert's syndrome;
- •- Aspartate Transaminase and Alanine Transaminase (AST/ALT) <3 X institutional Upper Limits of Normality (ULN);
- •- Creatinine within normal institutional limits or creatinine clearance >50 mL/min/1.73 m2 (Appendix C);
- •- Females of childbearing must have a negative pregnancy test at medical supervision even if had been using effective contraception;
- •- Life expectancy > 6 months;
- •- Able to adhere to the study visit schedule and other protocol requirements;
- •- Sign (or their legally acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study;
- •- Access to PET-CT scans facilities qualified by FIL;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Nodular Lymphocyte Predominant HL
- •- Ann Arbor stage IIB without extranodal involvement and/or bulky
- •- Prior chemotherapy or radiation therapy
- •- Pregnant or lactating females
- •- Known hypertension (as defined by the updated Guidelines [76]), cardiac arrhythmia, conduction abnormalities, ischemic cardiopathy, left ventricular hypertrophy or left ventricular ejection fraction (LVEF) =50% at echocardiography.
- •- Abnormal QTc interval prolonged (>450 msec in males; >470 msec in women)
- •- Diffusion lung capacity for CO (DLCO) and/or forced expiratory volume in the 1st second (FEV1) tests <50% of predicted not related to impaired respiratory capacity due to airway compression by mediastinal masses or parenchymal lymphoma (see chapter 16)
- •- Known cerebral or meningeal disease (HL or any other etiology)
- •- Prior history of malignancies unless the patient has been free of the disease for five years. Exceptions include the following:
- •o Basal cells carcinoma of the skin
- •o Squamous cell carcinoma of the skin
- •o Carcinoma in situ of the cervix
- •o Carcinoma in situ of the breast
- •o Prostate cancer with TNM stage T1a or T1b
- •- Uncontrolled infectious disease
- •- Human immunodeficiency virus (HIV) positivity or active infectious A, B or C hepatitis. HBsAg-negative patients with anti-HBc positive antibody can be enrolled provided that Hepatitis B Virus (HBV)-DNA are negative and that antiviral treatment with nucleos(t)ide analogs is provided
- •- Uncompensated diabetes
- •- Refusal of adequate contraception
- •- Any medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment.
研究者
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