Safety and Efficacy of Fludarabine and Cyclophosphamide + Rituximab

Phase 2

Completed

• Conditions: Follicular Lymphoma

• Registration Number: NCT00393107
• Lead Sponsor: Gruppo Italiano Studio Linfomi

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 duration. The majority of patients eventually die of their disease. As yet, there is no gold standard for the treatment of newly diagnosed or relapsed advanced FL.Rituximab(R) has been shown to be a highly effective agent in the treatment of FL, either alone or in combination with chemotherapy. The ability of R to sensitize indolent lymphoma derived cell lines to cytotoxic chemotherapy agents has been demonstrated. Furthermore, fludarabine (F) may also sensitize cells to the effects of R. Cyclophosphamide (C) and F have shown in vivo synergistic activity. In view of the single agent activity and demonstrated synergy between C and F, and between F and R, we evaluated FC+R in previously treated patients with advanced FL. The primary aim of this study was to assess the safety profile and clinical activity of the FC+R combination. The secondary goal was to evaluate the ability of the treatment to convert bone marrow Bcl2 positivity such that patients achieved molecular remissions.

Study Timeline

• Study Start: 2000-03
• Study Completion: 2006-08
• Status Verified: 2006-10
• Study First Submitted: 2006-10-25
• Study First Submitted QC: 2006-10-25
• Last Update Submitted: 2006-10-25
• Study First Posted: 2006-10-26
• Last Update Posted: 2006-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Toxicity during the treatment period
Efficacy evaluated in terms of complete and partial response 1 month after the end of therapy

Secondary Outcome Measures

Name	Time	Method
Efficacy evaluated in terms of molecular response ( bone marrow Bcl2 negativity after treatment)

Trial Locations

Locations (9)

Ospedale Monteluce; 🇮🇹 Perugia, Italy

Ospedale S. Maria Nuova; 🇮🇹 Reggio Emilia, Italy

Ospedale Maggiore di Milano; 🇮🇹 Milano, Italy

Ospedale di Piacenza; 🇮🇹 Piacenza, Italy

Ospedale di Arezzo; 🇮🇹 Arezzo, Italy

Ospedale di Pescara; 🇮🇹 Pescara, Italy

Ospedale di Reggio Calabria; 🇮🇹 Reggio Calabria, Italy

Ospedale Molinette; 🇮🇹 Torino, Italy

Ospedale di Pisa; 🇮🇹 Pisa, Italy