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Safety and Efficacy of Fludarabine and Cyclophosphamide + Rituximab

NCT ID: NCT00393107

Last Updated: 2006-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2006-08-31

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.

Conditions

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Follicular Lymphoma

Keywords

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follicular lymphoma non-Hodgkin lymphoma Fludarabine Cyclophosphamide Rituximab combination immuno-chemotherapy relapsed

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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rituximab

Intervention Type DRUG

rituximab,fludarabine, cyclophosphamide

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Studio Linfomi

OTHER

Sponsor Role lead

Principal Investigators

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Sacchi Stefano, MD

Role: PRINCIPAL_INVESTIGATOR

GISL

Locations

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Ospedale di Arezzo

Arezzo, , Italy

Site Status

Ospedale Maggiore di Milano

Milan, , Italy

Site Status

Ospedale Monteluce

Perugia, , Italy

Site Status

Ospedale di Pescara

Pescara, , Italy

Site Status

Ospedale di Piacenza

Piacenza, , Italy

Site Status

Ospedale di Pisa

Pisa, , Italy

Site Status

Ospedale di Reggio Calabria

Reggio Calabria, , Italy

Site Status

Ospedale S. Maria Nuova

Reggio Emilia, , Italy

Site Status

Ospedale Molinette

Torino, , Italy

Site Status

Countries

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Italy

References

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Alas S, Bonavida B. Rituximab inactivates signal transducer and activation of transcription 3 (STAT3) activity in B-non-Hodgkin's lymphoma through inhibition of the interleukin 10 autocrine/paracrine loop and results in down-regulation of Bcl-2 and sensitization to cytotoxic drugs. Cancer Res. 2001 Jul 1;61(13):5137-44.

Reference Type BACKGROUND
PMID: 11431352 (View on PubMed)

Alas S, Emmanouilides C, Bonavida B. Inhibition of interleukin 10 by rituximab results in down-regulation of bcl-2 and sensitization of B-cell non-Hodgkin's lymphoma to apoptosis. Clin Cancer Res. 2001 Mar;7(3):709-23.

Reference Type BACKGROUND
PMID: 11297268 (View on PubMed)

Di Gaetano N, Xiao Y, Erba E, Bassan R, Rambaldi A, Golay J, Introna M. Synergism between fludarabine and rituximab revealed in a follicular lymphoma cell line resistant to the cytotoxic activity of either drug alone. Br J Haematol. 2001 Sep;114(4):800-9. doi: 10.1046/j.1365-2141.2001.03014.x.

Reference Type BACKGROUND
PMID: 11564066 (View on PubMed)

Bellosillo B, Villamor N, Colomer D, Pons G, Montserrat E, Gil J. In vitro evaluation of fludarabine in combination with cyclophosphamide and/or mitoxantrone in B-cell chronic lymphocytic leukemia. Blood. 1999 Oct 15;94(8):2836-43.

Reference Type BACKGROUND
PMID: 10515887 (View on PubMed)

Sacchi S., Tucci A, Merli F, Orsucci L, Cervetti G, Occhini U, Liberati M, Tarantini G, Callea V, Brugiatelli M, Lauta VM, Baldini L, Luminari S, Federico M. Dipartimento di Oncologia ed Ematologia,. Phase II Study with Fludarabine and Cyclophosphamide Plus Rituximab (FC+R) in Relapsed Follicular Lymphoma Patients. ASH 2002. Blood 99, 2002 Ab n° 530

Reference Type BACKGROUND

Related Links

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http://www.gisl.org

Related Info

Other Identifiers

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FolRec02

Identifier Type: -

Identifier Source: secondary_id

GislFR2

Identifier Type: -

Identifier Source: secondary_id

FR2

Identifier Type: -

Identifier Source: org_study_id