A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Is a pregnant or nursing woman
- Is unable to comply with requirements of study