EUCTR2011-005473-22-DK进行中（未招募）不适用
Very early FDG-PET/CT-response adapted therapy for advanced stage Hodgkin Lymphoma, a randomized phase III non-inferiority study of the EORTC Lymphoma Group.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- EORTC
- 入组人数
- 570
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
- •* Previously untreated, histologically proven classical Hodgkin lymphoma
- •* Clinical stages III/IV (Ann Arbor, see Appendix F)
- •* Age 18-60
- •* WHO performance 0-2 (see Appendix C)
- •* FDG-PET/CT scan prospectively planned after one cycle of chemotherapy in all patients
- •* Adequate organ function:
- •New York Heart Association (NYHA) functional classification = II (EF = 50% or FS = 25%)
- •No symptomatic coronary heart disease (stable angina pectoris is allowed),
- •No severe uncontrolled hypertension.
- •? Liver: Total Bilirubin = 2 x UNL, alanine aminotransferase (ALT, SGPT) = 3 x UNL, aspartate aminotransferase (AST, SGOT) = 3 x UNL (exception: elevated values due to HL liver involvement).
- •? Kidney: creatinine clearance = 60 ml/min (measured or calculated according to the method of Cockcroft), uric acid, calcium (all ? Hematological: Hemoglobin = 10 g/dl, Leukocyte concentration = 3.0 x 109/L absolute neutrophil count = 1.5 x 109/L, platelets = 75 x 109 /L. (exception: reduced values related to HL (e.g. BM infiltration, splenomegaly))
- •Patients with a buffer range from the normal values of +/- 10% for hematology and +/- 10% for biochemistry are acceptable.
- •* Patients of childbearing/reproductive potential should use adequate birth control measures during the whole duration of study treatment.
- •? Female subjects of childbearing potential (defined as any female subject unless she meets at least one of the following criteria: Age =50 years and naturally amenorrheic for = 1 year {amenorrhea following cancer therapy does not rule out childbearing potential}, premature ovarian failure confirmed by a specialist gynecologist, previous bilateral salpingo-oophorectomy or hysterectomy, XY genotype, Turner syndrome or uterine agenesis.) must:
- •? Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days before the start of study medication. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
- •EORTC 20101-23101 H11
- •Version 1.0 14 / 115 August 06, 2012
- •? Male subjects must:
- •? Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
- •? Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
- •* Written informed consent according to ICH/EU Good Clinical Practice, and national/local regulations
- •* No pregnancy or breast feeding
- •* No specific contraindications to BEACOPPesc therapy, so therefore:
- •? No poorly controlled diabetes mellitus
- •? No known HIV infection
- •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 570
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •No pregnancy or breast feeding
- •? No specific contraindications to BEACOPPesc therapy, so therefore:
- •? poorly controlled diabetes mellitus
- •? known HIV infection
- •? chronic active hepatitis B and/or hepatitis C
- •? concomitant or previous malignancies with the exception of basal cell skin tumors, adequately treated carcinoma in situ of the cervix and any cancer that has been in complete remission for > 5 years
研究者
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