A Pilot Phase II Trial of Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma
Inclusion Criteria:
- Pathologic diagnosis of Non-Hodgkin's Lymphoma of the mantle cell sub-type lymphoma
only, as determined by morphologic assessment and consistent immunophemotypic markers
- Newly diagnosed and patients who have received prior treatment are eligible
- Measurable or evaluable disease
- Karnofsky performance status greater or equal to 50%
- Men and women, age greater or equal to 18 years old
- AGC greater or equal to 1.0; platelets greater or equal to 75,000; Hemoglobin greater
or equal to 8.0 (unless because of lymphomatous infiltration of the marrow)
- Creatinine less than 2.0; bilirubin less than 2.0; SGOT less than 3 times upper limit
of normal (unless elevations are due to lymphomatous involvement)
- Women of child bearing potential must have negative pregnancy test within 14 days of
study entry.
- Signed informed consent
Exclusion Criteria:
- History of congestive heart failure or significant cardiac disease
- Prior exposure to either fludarabine or mitoxantrone. Prior exposure to rituximab
allowed
- Active infection
- HIV seropositive
- Pregnant or lactating females
- Second active malignancy, other than squamous cell skin cancer,in-situ cervical
cancer, or history of other cancer diagnosed within the preceding 5 years
- Presence of psychological or emotional disorders which would make valid informed
consent impossible