Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell
Condition: Relapsed or Refractory Mantle Cell Lymphoma (MCL)
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: gemcitabine; mitoxantrone; rituximab
Intervention description: 900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar-->Novantrone-->Rituxan.; Novantrone 10 mg/m2on Day 1. The order of administration will be:
Gemzar-->Novantrone-->Rituxan.; Rituxan 375 mg/m2 on Day 1. The order of administration will be:
Gemzar-->Novantrone-->Rituxan.
Intervention MeSH terms: Rituximab; Gemcitabine; Mitoxantrone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone,
      and Rituxan in relapsed or refractory MCL
    

Eligibility criteria:

        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