Safety and Efficacy of Fludarabine and Cyclophosphamide + Rituximab

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose of this study was to assess the safety profile and the anti-lymphoma activity of the FC+R combination.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Studio Linfomi
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Rituximab; Vidarabine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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