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Related Studies
Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma
This study has been terminated.
( Insufficient accrual )
First Received: September 12, 2005   Last Updated: January 18, 2008   History of Changes
Sponsored by: Norris Comprehensive Cancer Center
Information provided by: Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00183989
  Purpose

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 Intervention Phase
Mantle Cell Lymphoma
Drug: Fludarabine, Mitoxantrone and Rituximab
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Fludarabine Mitoxantrone Mitoxantrone hydrochloride Fludarabine monophosphate Rituximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Pilot Phase II Trial of Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma

Further study details as provided by Norris Comprehensive Cancer Center:

Estimated Enrollment: 30
Study Start Date: August 2000
Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183989

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

No publications provided

Study ID Numbers: 13NHL-99-2
Study First Received: September 12, 2005
Last Updated: January 18, 2008
ClinicalTrials.gov Identifier: NCT00183989     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Antimetabolites
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Lymphoma, Mantle-Cell
Mantle Cell Lymphoma
Fludarabine monophosphate
Immunosuppressive Agents
Lymphatic Diseases
Fludarabine
Mitoxantrone
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Lymphoma, Mantle-Cell
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Analgesics
Lymphoma
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Rituximab
Fludarabine monophosphate
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Mitoxantrone
Fludarabine
Peripheral Nervous System Agents
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009