Status:
COMPLETED
Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell
Lead Sponsor:
US Oncology Research
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00656084
Start Date
December 1 2004
End Date
January 1 2008
Last Update
November 3 2016
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