Clareo Health | A Pilot Study of Standard-Dose Rituximab, Ifosfamide, Carboplatin and Etoposide (RICE) Plus Bortezomib (Velcade) in a Dose-Escalating Fashion for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Who Are Candidates for Autologous Stem Cell Transplant
A Pilot Study of Standard-Dose Rituximab, Ifosfamide, Carboplatin and Etoposide (RICE) Plus Bortezomib (Velcade) in a Dose-Escalating Fashion for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Who Are Candidates for Autologous Stem Cell Transplant
Measurable disease on CT scan by international working group response criteria
No CNS involvement
Subject is considered to be a candidate for autologous stem cell transplant in the opinion of the treating physician
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control
Male subject agrees to use an acceptable method of contraception for the duration of the study
You may not be if
Platelet count of \<75 x 10(9)/L
Absolute neutrophil count of \<1.0 x 10(9)/L
Calculated or measured creatinine clearance of \<60 mL/minute within 14 days before enrollment
Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association 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 ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
Subject has hypersensitivity to bortezomib, boron or mannitol.
Female subject is pregnant or breast-feeding.
Subject has been treated with more than one prior chemotherapy regimen.
Subject has received other investigational drugs with 14 days before enrollment.
Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
