Safety and Efficacy of Fludarabine and Cyclophosphamide + Rituximab

October 25, 2006 updated by: Gruppo Italiano Studio Linfomi

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Arezzo, Italy, 52100
        • Ospedale di Arezzo
      • Milano, Italy, 20100
        • Ospedale Maggiore di Milano
      • Perugia, Italy, 06110
        • Ospedale Monteluce
      • Pescara, Italy, 89100
        • Ospedale di Pescara
      • Piacenza, Italy, 29100
        • Ospedale di Piacenza
      • Pisa, Italy, 56100
        • Ospedale di Pisa
      • Reggio Calabria, Italy, 89100
        • Ospedale di Reggio Calabria
      • Reggio Emilia, Italy, 42100
        • Ospedale S. Maria Nuova
      • Torino, Italy, 10100
        • Ospedale Molinette

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Efficacy evaluated in terms of molecular response ( bone marrow Bcl2 negativity after treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Studio Linfomi

Investigators

  • Principal Investigator: Sacchi Stefano, MD, GISL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Study Completion

August 1, 2006

Study Registration Dates

First Submitted

October 25, 2006

First Submitted That Met QC Criteria

October 25, 2006

First Posted (Estimate)

October 26, 2006

Study Record Updates

Last Update Posted (Estimate)

October 26, 2006

Last Update Submitted That Met QC Criteria

October 25, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FR2
  • FolRec02
  • GislFR2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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