Randomized Phase II Study of Dose-Adjusted EPOCH-Rituximab-Bortezomib (EPOCH-R-B) Induction Followed by Bortezomib Maintenance Versus Observation in Untreated Mantle Cell Lymphoma With Microarray Profiling and Proteomics

Fecha de inicio: 15 de junio de 2005

* ELIGIBILITY CRITERIA: Diagnosis of mantle cell lymphoma (confirmed at National Cancer Institute (NCI)). All variants are eligible. Age greater than or equal to 18 years. No prior treatment except for local radiation or a short course of steroids for control of symptoms. All stages of disease. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3. Adequate major organ function (serum creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 50 ml/min; bilirubin less than 2 mg/dl (total) except less than 5 mg/dl in patients with Gilbert's syndrome as defined by greater than 80% unconjugated; Absolute neutrophil count (ANC) greater than 1000 and platelets greater than 75,000) unless impairment due to organ involvement by lymphoma. No myocardial infarction within 6 months prior to enrollment or New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any electrocardiogram (ECG) abnormality at Screening has to be documented by the investigator as not medically relevant. No grade 2 greater than or equal to peripheral neuropathy within 14 days before enrollment. Ability to give informed consent. Human immunodeficiency virus (HIV) antibody negative. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Female subject is not pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-human chorionic gonadotropin (hCG)) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women Male subject agrees to use an acceptable method for contraception for the duration of the study. No history of a prior invasive malignancy in past 5 years No known involvement of central nervous system by lymphoma No history of hypersensitivity to boron or mannitol. Patient has not received other investigational drugs with 14 days before enrollment. No serious medical or psychiatric illness likely to interfere with participation in this clinical study. Exclusion for fludeoxyglucose (FDG) scan is anyone exceeding the weight limit of the scanner (350 lb).