Safety and Efficacy of Fludarabine and Cyclophosphamide + Rituximab

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

Detailed Description
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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.

Official Title
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Phase II Study of Rituximab in Combination With Fludarabine and Cyclophosphamide for the Treatment of Relapsed Follicular Lymphoma

Conditions
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Follicular Lymphoma

Intervention / Treatment
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* Drug: rituximab
* Drug: rituximab,fludarabine, cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rituximab|nan|
|Drug: rituximab,fludarabine, cyclophosphamide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity during the treatment period |  |  | 
| Efficacy evaluated in terms of complete and partial response 1 month after the end of therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy evaluated in terms of molecular response ( bone marrow Bcl2 negativity after treatment) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immuno-chemotherapy, follicular lymphoma, non-Hodgkin lymphoma, Fludarabine, Cyclophosphamide, Rituximab, combination, relapsed