Status:
COMPLETED
Safety and Efficacy of Fludarabine and Cyclophosphamide + Rituximab
Lead Sponsor:
Gruppo Italiano Studio Linfomi
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Purpose of this study was to assess the safety profile and the anti-lymphoma activity of the FC+R combination.
Detailed Description
The natural history of follicular lymphomas is characterized by a high initial response rate to chemotherapy followed invariably by relapse, with subsequent remissions of progressively shorter duratio...
Eligibility Criteria
Inclusion
- histologically documented WHO grade 1-2 ,CD20+,follicular lymphoma
- relapsed Follicular lymphoma
- stage III or IV disease
- Stage II patients are eligible if they present with B symptoms or bulky disease
- to have a need for therapy in the opinion of treating clinician
- measurable disease
- expected survival of 6 months or more
- age 18 to 70 years
- to have undergone \< 3 lines of chemotherapy
- performance status of 0 to 2
Exclusion
- known HIV infections
- Known Hepatitis B or C
- CNS lymphoma
- previous malignancies, or cardiac, renal, hepatic, or respiratory failure
- Pregnant or lactating women and patients of child bearing potential unless using birth control measures
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00393107
Start Date
March 1 2000
End Date
August 1 2006
Last Update
October 26 2006
Active Locations (9)
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1
Ospedale di Arezzo
Arezzo, Italy, 52100
2
Ospedale Maggiore di Milano
Milan, Italy, 20100
3
Ospedale Monteluce
Perugia, Italy, 06110
4
Ospedale di Pescara
Pescara, Italy, 89100