Status:
COMPLETED
Rituximab and Fludarabine Followed by CAMPATH-1H in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Bayer
Conditions:
Non-Hodgkins Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this multicenter trial, we will investigate the use of fludarabine plus rituximab, followed by Campath-1H, in previously untreated patients with CLL/SLL. Patients who are elderly, or who are consid...
Detailed Description
Upon determination of eligibility, all patients will receive: Fludarabine + Rituximab + CAMPATH-1H Patients who are judged by the investigator not to be candidates for fludarabine due to advanced ag...
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Histologically proven B-cell CLL/SLL
- Positive staining for CD20 antigen
- No systemic chemotherapy.
- Measurable or evaluable disease
- Able to perform activities of daily living with minimal assistance
- Age \> 18 years
- Life expectancy \> 12 weeks
- Adequate liver and kidney function
- Must be accessible for treatment and follow-up
- Must give written informed consent prior to entering this study.
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Female pregnant or lactating
- Unstabilized active infection on the basis of neutropenia
- History of previous severe opportunistic infections
- Serious underlying medical conditions
- Central nervous system involvement
- History of other neoplasms, either active or treated within five years
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00193466
Start Date
January 1 2002
End Date
April 1 2008
Last Update
December 30 2010
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