Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Oncology Research
• Collaborator: Eli Lilly and Company
• Treatments: Gemcitabine; Mitoxantrone; Rituximab

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