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Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma

Information source: University of Southern California
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mantle Cell Lymphoma

Intervention: Fludarabine, Mitoxantrone and Rituximab (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: University of Southern California

Official(s) and/or principal investigator(s):
Alexandra M. Levine, MD, Principal Investigator, Affiliation: University of Southern California


This study is being done in order to determine the effectiveness of the combination of fludarabine, mitoxantrone, and rituximab in patients with mantle cell lymphoma. All three drugs,fludarabine, mitoxantrone, and rituximab have been approved by the U. S. Food and Drug Administration (FDA)for the treatment of certain types of lymphoma. Rituximab is a drug (called a monoclonal antibody) which has anti-tumor activity on certain types of lymphoma. The combination of chemotherapy (fludarabine and mitoxantrone) with rituximab has not yet been investigated in patients with mantle cell lymphoma and therefore the combination in investigational.

Clinical Details

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

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Norris Comprehensive Cancer Center, Los Angeles, California 90033, United States
Additional Information

Starting date: August 2000
Last updated: May 20, 2014

Page last updated: August 23, 2015

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