IGEV +/- Bortezomib (VelcadeTM) as induction before high dose consolidation in relapsed/ refractory Hodgkin?s lymphoma after first line treatment : a randomized phase II trial - ONC-2006-005

ISTITUTO CLINICO HUMANITAS0 个研究点开始时间: 2008年2月13日最近更新: 2013年12月23日

试验速览

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•Diagnosis of Hodgkin?s lymphoma failing or relapsing after first-line chemotherapy (MOPP/AVBD , MOPP/EBV/CAD and analogs are considered one line)
•Age >18 and <65 years
•The patient meets the following pretreatment laboratory criteria at and within 21 days before baseline (Day 1 of Cycle 1, before study drug administration):
•-Platelet count >100 x 109/L, unless lower values are due to bone marrow-infiltration (in this case, platelet >50 x 109/L are admitted).
•-Hemoglobin >7.5 g/dL, with or without transfusion support we ask for 7.5 g/dL at baseline in our protocols
•-Absolute neutrophil count (ANC .1.5 x 109/L unless lower values are due to bone marrow-infiltration (in this case, ANC >0.75 x 109/L are admitted)
•-Serum calcium <3.5 mmol/L (<14 mg/dL)
•-Aspartate transaminase (AST): <2.5 x the ULN
•-Alanine transaminase (ALT): <2.5 x the ULN
•-Total bilirubin: <1.5 x the ULN
•The patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to his or her future medical care
•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Previous treatment with velcade
•Patient has received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment
•Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection
•History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances including diabetes mellitus

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ISTITUTO CLINICO HUMANITAS