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

Sponsor

University of Southern California (Other)

Overall Status

Terminated

CT.gov ID

NCT00183989

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2000

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033

Sponsors and Collaborators

University of Southern California

Investigators

Principal Investigator: Alexandra M. Levine, MD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Southern California

ClinicalTrials.gov Identifier:

NCT00183989

Other Study ID Numbers:

13NHL-99-2

First Posted:

Sep 16, 2005

Last Update Posted:

May 22, 2014

Last Verified:

May 1, 2014

Additional relevant MeSH terms:

Lymphoma

Lymphoma, Mantle-Cell

Rituximab

Fludarabine

Mitoxantrone

Study Results

No Results Posted as of May 22, 2014