Status:
TERMINATED
Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma
Lead Sponsor:
University of Southern California
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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, mito...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00183989
Start Date
August 1 2000
End Date
December 1 2006
Last Update
May 22 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033