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2021年6月17日
适应症Advanced stage (IIB-IV) Hodgkin Lymphoma.MedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
相关药物DOXORUBICINA ACCORD HEALTHCARE ITALIA - 2MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 100MG/50MLBLEOPRIM - 15 MG POLVERE PER SOLUZIONE INIETTABILE 1 FLACONCINOVINBLASTINA TEVA - 1 MG/ML SOLUZIONE INIETTABILE 1 FLACONCINO DA 10 MLDACARBAZINA LIPOMED - 200 MG POLVERE PER SOLUZIONE INIETTABILE O PER INFUSIONE 10 FLACONCINI
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Advanced stage (IIB-IV) Hodgkin Lymphoma.
- 发起方
- FONDAZIONE ITALIANA LINFOMI ONLUS
- 入组人数
- 500
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
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);
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
结局指标
主要结局
未指定
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