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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00183989
Recruitment Status : Terminated (Insufficient accrual)
First Posted : September 16, 2005
Last Update Posted : May 22, 2014
Information provided by (Responsible Party):
University of Southern California

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma Drug: Fludarabine, Mitoxantrone and Rituximab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Phase II Trial of Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma
Study Start Date : August 2000
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00183989

United States, California
Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Principal Investigator: Alexandra M. Levine, MD University of Southern California

Responsible Party: University of Southern California Identifier: NCT00183989     History of Changes
Other Study ID Numbers: 13NHL-99-2
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Fludarabine phosphate
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Antiviral Agents
Anti-Infective Agents
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors