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

Primary Purpose

Mantle Cell Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fludarabine, Mitoxantrone and Rituximab
Sponsored by
University of Southern California
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Norris Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
May 20, 2014
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT00183989
Brief Title
Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma
Official Title
A Pilot Phase II Trial of Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Insufficient accrual
Study Start Date
August 2000 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fludarabine, Mitoxantrone and Rituximab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra M. Levine, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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