NCT00393107

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2000

Longer than P75 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
6.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
Last Updated

October 26, 2006

Status Verified

October 1, 2006

First QC Date

October 25, 2006

Last Update Submit

October 25, 2006

Conditions

Follicular Lymphoma

Keywords

follicular lymphomanon-Hodgkin lymphomaFludarabineCyclophosphamideRituximabcombinationimmuno-chemotherapyrelapsed

Outcome Measures

Primary Outcomes (2)

  • Toxicity during the treatment period

  • Efficacy evaluated in terms of complete and partial response 1 month after the end of therapy

Secondary Outcomes (1)

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

Interventions

rituximabDRUG
rituximab,fludarabine, cyclophosphamideDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Ospedale di Arezzo

Arezzo, 52100, Italy

Location

Ospedale Maggiore di Milano

Milan, 20100, Italy

Location

Ospedale Monteluce

Perugia, 06110, Italy

Location

Ospedale di Pescara

Pescara, 89100, Italy

Location

Ospedale di Piacenza

Piacenza, 29100, Italy

Location

Ospedale di Pisa

Pisa, 56100, Italy

Location

Ospedale di Reggio Calabria

Reggio Calabria, 89100, Italy

Location

Ospedale S. Maria Nuova

Reggio Emilia, 42100, Italy

Location

Ospedale Molinette

Torino, 10100, Italy

Location

Related Publications (5)

  • 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.

    PMID: 11431352BACKGROUND

  • 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.

    PMID: 11297268BACKGROUND

  • 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.

    PMID: 11564066BACKGROUND

  • 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.

    PMID: 10515887BACKGROUND

  • 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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Lymphoma, FollicularLymphoma, Non-HodgkinRecurrence

Interventions

RituximabfludarabineCyclophosphamide

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Sacchi Stefano, MD

    GISL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2006

First Posted

October 26, 2006

Study Start

March 1, 2000

Study Completion

August 1, 2006

Last Updated

October 26, 2006

Record last verified: 2006-10

Locations

IT(9)