Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
City of Hope Medical Center
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥18 years
Diagnosis of mantle cell lymphoma (MCL) established by histologic assessment
Laboratory, radiographic, physical exam findings and/or symptoms attributable to MCL
ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death) less or equal to 2
All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
Men and Women of childbearing potential on appropriate contraception
Adequate organ function
Ability to understand and the willingness to sign a written informed consent.
Ability to swallow oral capsules/tablets
You may not be if
Prior treatment for MCL with chemotherapy
Pregnant or breastfeeding women
Grade 2 or higher peripheral neuropathy
Known history of CNS (Central Nervous System) or leptomeningeal by MCL prior to study enrollment
Significant cardiovascular disease
Any condition that might significantly impair drug absorption as determined by the investigator
Uncontrolled active systemic fungal, bacterial, viral, or other infection, or intravenous anti-infective treatment within 2 weeks before first dose of study drug
History of stroke or intracranial hemorrhage within 6 months of 1st dose of study drug
Concurrent participation in another clinical trial
Subject has received a moderate or strong CYP3A inhibitor or inducer within 1 week prior to treatment initiation.
Psychiatric illness or social situations that would limit compliance with study requirements
Subject has known positivity to HIV
Active infection with Hepatitis B or C virus as determined by a detectable viral load on PCR.
Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to\< 2 years.
