Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
US Oncology Research
With
Eli Lilly and Company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Stage III or IV, histologically confirmed relapsed or refractory MCL as reviewed by the SI
Is CD20 positive (by immunohistochemistry or FACS)
Is Cyclin D positive (by immunohistochemistry or FACS)
Has received prior chemotherapy (required minimum of 1 prior therapies)
Has received prior treatment with Rituxan
Has an ECOG Performance Status (PS) 0-2
Is greater than or equal to 18 years of age
Has appropriate laboratory values (please refer to protocol for specific laboratory values)
If a history of cardiac disease is indicated, patient has an LVEF greater than or equal to 50% (MUGA)
Has a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential)
If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 2 months thereafter
Has signed a Patient Informed Consent Form
Has signed a Patient Authorization Form
You may not be if
Has other lymphomas not classified as MCL
Has had prior treatment with Gemzar and/or Novantrone
A history of known hypersensitivity to Gemzar, Novantrone, Rituxan, or any component of these drugs
Has a history of hypersensitivity to murine-cell derived therapeutics
Has a LVEF indicative of a cardiac condition (LVEF \< 50%)
Is receiving concurrent immunotherapy
Has evidence of CNS involvement
Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
