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A Pilot Phase II Trial of Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma

Phase 2
18 Years
Not Enrolling
Mantle Cell Lymphoma

Thank you

Trial Information

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Alexandra M. Levine, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California


United States: Institutional Review Board

Study ID:




Start Date:

August 2000

Completion Date:

December 2006

Related Keywords:

  • Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell



Norris Comprehensive Cancer CenterLos Angeles, California  90033