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Safety and Efficacy of Fludarabine and Cyclophosphamide + Rituximab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00393107
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : October 26, 2006
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Drug: rituximab Drug: rituximab,fludarabine, cyclophosphamide 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 54 participants
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 : March 2000
Study Completion Date : August 2006





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)


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393107


Locations
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Italy
Ospedale di Arezzo
Arezzo, Italy, 52100
Ospedale Maggiore di Milano
Milano, Italy, 20100
Ospedale Monteluce
Perugia, Italy, 06110
Ospedale di Pescara
Pescara, Italy, 89100
Ospedale di Piacenza
Piacenza, Italy, 29100
Ospedale di Pisa
Pisa, Italy, 56100
Ospedale di Reggio Calabria
Reggio Calabria, Italy, 89100
Ospedale S. Maria Nuova
Reggio Emilia, Italy, 42100
Ospedale Molinette
Torino, Italy, 10100
Sponsors and Collaborators
Gruppo Italiano Studio Linfomi
Investigators
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Principal Investigator: Sacchi Stefano, MD GISL
Additional Information:
Publications:
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ClinicalTrials.gov Identifier: NCT00393107    
Other Study ID Numbers: FR2
FolRec02
GislFR2
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: October 26, 2006
Last Verified: October 2006
Keywords provided by Gruppo Italiano Studio Linfomi:
follicular lymphoma
non-Hodgkin lymphoma
Fludarabine
Cyclophosphamide
Rituximab
combination
immuno-chemotherapy
relapsed
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Rituximab
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological