Safety and Efficacy of Fludarabine and Cyclophosphamide + Rituximab

Sponsor
Gruppo Italiano Studio Linfomi (Other)
Overall Status
Completed
CT.gov ID
NCT00393107
Collaborator
(none)
54
Enrollment
9
Locations
77
Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

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 Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Rituximab in Combination With Fludarabine and Cyclophosphamide for the Treatment of Relapsed Follicular Lymphoma
Study Start Date :
Mar 1, 2000
Study Completion Date :
Aug 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Toxicity during the treatment period []

  2. Efficacy evaluated in terms of complete and partial response 1 month after the end of therapy []

Secondary Outcome Measures

  1. Efficacy evaluated in terms of molecular response ( bone marrow Bcl2 negativity after treatment) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Ospedale di ArezzoArezzoItaly52100
2Ospedale Maggiore di MilanoMilanoItaly20100
3Ospedale MontelucePerugiaItaly06110
4Ospedale di PescaraPescaraItaly89100
5Ospedale di PiacenzaPiacenzaItaly29100
6Ospedale di PisaPisaItaly56100
7Ospedale di Reggio CalabriaReggio CalabriaItaly89100
8Ospedale S. Maria NuovaReggio EmiliaItaly42100
9Ospedale MolinetteTorinoItaly10100

Sponsors and Collaborators

  • Gruppo Italiano Studio Linfomi

Investigators

  • Principal Investigator: Sacchi Stefano, MD, GISL

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00393107
Other Study ID Numbers:
  • FR2
  • FolRec02
  • GislFR2
First Posted:
Oct 26, 2006
Last Update Posted:
Oct 26, 2006
Last Verified:
Oct 1, 2006

Study Results

No Results Posted as of Oct 26, 2006