Multicentric Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Patients With Stage II-IV Follicular Lymphoma

February 14, 2011 updated by: Fondazione Italiana Linfomi ONLUS

Phase III Multicentric IIL Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Treatment of Patients With Stage II-IV Follicular Lymphoma

The purpose of this study is to define an improvement and theassessment of the Time to Treatment Failure in patients randomized in three different arms:

R-CVP vs R-CHOP vs R-FM.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. -Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP - Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments.

Study Type

Interventional

Enrollment (Actual)

534

Phase

  • Phase 3

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
      • Acquaviva delle fonti (BA), Italy
        • Ente Ecclesiastico Ospedale Generale Regionale Miulli
      • Alessandria, Italy
        • Az.Ospedaliera SS.Antonio, Biagio e Cesare Arrigo-U.O.A.Ematologia
      • Asti, Italy
        • Presidio Ospedaliero C.Massaia di Asti
      • Aviano, Italy
        • Istituto Nazionale Tumori
      • Bari, Italy
        • IRCCS Istituto Tumori Giovanni Paolo II
      • Biella, Italy
        • Divisione Medicina B Ospedale degli Infermi
      • Bologna, Italy
        • Policlinico Sant'Orsola - Istituto di Ematologia e Oncologia medica L.e A. Seragnoli
      • Bolzano, Italy
        • Ospedale di Bolzano Divisione di Ematologia e Centro Trapianti di Midollo Osseo
      • Brescia, Italy
        • A.O.Spedali Civili di Brescia
      • Brindisi, Italy
        • Presidio Ospedaliero A.Perrino
      • Cagliari, Italy
        • Ospedale Businco, Divisione di Ematologia
      • Camposanpiero (PD), Italy
        • Ospedale Civile
      • Candiolo (TO), Italy
        • Istituto per la ricerca e la cura del cancro
      • Carpi (MO), Italy
        • A.O. dell'Annunziata Unita' Operativa di Ematologia
      • Carpi (Mo), Italy
        • Ospedale Ramazzini Day Hospital Oncologico
      • Catania, Italy
        • Ospedale Garibaldi-Nesima
      • Catania, Italy
        • Universita' degli studi di Catania
      • Catanzaro, Italy
        • A.O. Pugliese A. Ciaccio
      • Catanzaro, Italy
        • A.O.Pugliese Ciaccio Diviisone di Ematologia
      • Chivasso (TO), Italy
        • Ospedale civico di Chivasso
      • Ciriè (TO), Italy
        • Ospedale di Ciriè U.O.N.A. Oncologia servizio di Ematologia
      • Civitanova Marche (MC), Italy
        • Ospedale civile Divisione di Ematologia
      • Correggio (RE), Italy
        • Ospedale San Sebastiano
      • Cosenza, Italy
        • Presidio Ospedaliero Annunziata
      • Cremona, Italy
        • Azienda istituti ospedalieri di Cremona
      • Firenze, Italy
        • Policlinico Careggi, cattedra e diviisone di Ematologia
      • Genova, Italy
        • Ospedale San Martino - Divisione di Ematologia
      • Genova, Italy
        • E.O.Ospedali Galliera U.O.Ematologia
      • La Spezia, Italy
        • Ospedale Felettino reparto di Oncologia
      • Lecce, Italy
        • Ospedale Vito Fazzi
      • Lecco, Italy
        • Ospedale A.Manzoni Oncologia medica
      • Matera, Italy
        • Ospedale Madonna delle grazie U.O. Ematologia
      • Messina, Italy
        • Azienda Ospedaliera Papardo
      • Messina, Italy
        • Policlinico universitario U.O. Ematologia
      • Milano, Italy
        • Osp. San Carlo Borromeo Divisione di Oncologia Medica
      • Milano, Italy
        • Ospedale Niguarda Ca' Granda
      • Milano, Italy
        • Azienda Ospedaliera Fatebenefratelli e Oftalmico
      • Milano, Italy
        • IRCCS San Raffaele Unità di Chemioterapia
      • Milano, Italy
        • Ospedale Maggiore IRCCS-Dipartimento di Ematologia
      • Milano, Italy
        • Ospedale San Paolo U.O. Oncologia Medica
      • Modena, Italy
        • Policlinico di Modena - Università degli studi
      • Monza (MI), Italy
        • Ospedale S. Gerardo Divisione di ematologia
      • Napoli, Italy
        • AORN Cardarelli U.O.Ematologia
      • Noale, Italy
        • Ospedale P.F.Calvi dipartimento id Oncologia ed Ematologia
      • Nocera Inferiore, Italy
        • Presidio Ospedaliero Umberto I Medicina ed Onco-Ematologia
      • Novara, Italy
        • A.O. Maggiore della Carità S.C.D.U. Ematologia
      • Padova, Italy
        • A.O. di Padova Divisione di Oncologia Medica
      • Palermo, Italy
        • Policlinico P.Giaccone
      • Palermo, Italy
        • Casa di cura La Maddalena Unita' di Ematologia
      • Parma, Italy
        • Universita' degli Studi di Parma
      • Pavia, Italy
        • Policlinico San Matteo - Medicina generale
      • Pavia, Italy
        • Policlinico San Matteo
      • Perugia, Italy
        • Policlinico Monteluce Divisione di Ematologia
      • Pescara, Italy
        • Ospedale Santo Spirito Dipartimento di Ematologia
      • Pescara, Italy
        • Ospedale Santo Spirito-Dipartimento di Oncologia
      • Piacenza, Italy
        • Ospedale Civile, Sezione di Ematologia
      • Pisa, Italy
        • Ospedale S. Chiara Azienda ospedaliera pisana
      • Reggio Calabria, Italy
        • Presidio Ospedali riuniti "Bianchi, Melacrino, Morelli" Divisione di ematologia
      • Reggio Emilia, Italy
        • Azienda ospedaliera Arcispedale S.Maria Nuova
      • Rionero in Vulture (PZ), Italy
        • Ospedale Oncologico regionale CROB
      • Roma, Italy
        • Istituto Regina Elena
      • Roma, Italy
        • A.O.S.Andrea Reparto di Ematologia e Immunoematologia
      • Roma, Italy
        • Azienda Policlinico Umberto I - La Sapienza
      • Roma, Italy
        • Ospedale San Giacomo U.O. Ematologia
      • Roma, Italy
        • Policlinico A. Gemelli Università Cattolica del Sacro Cuore
      • Roma, Italy
        • Policlinico Universitario Campus Biomedico
      • Roma, Italy
        • Policlinico Universitario Tor Vergata
      • Roma, Italy
        • Universita' La Sapienza
      • Ronciglione (VT), Italy
        • P.O. Roncilgione U.O. Ematologia
      • Rozzano (MI), Italy
        • Istituto Clinco Humanitas
      • San Giovanni Rotondo (FG), Italy
        • IRCCS Casa Sollievo della Sofferenza
      • Sassari, Italy
        • Istituto di Ematologia Università degli studi di Sassari
      • Sassuolo (MO), Italy
        • Ospedale civile DH oncologico
      • Savona, Italy
        • Ospedale San Paolo
      • Sondalo, Italy
        • A.O. della Valtellina e della Valchiavenna Presidio Ospedaliero di Sondalo
      • Terni, Italy
        • Azienda Ospedaliera S. Maria
      • Terni, Italy
        • Ospedale S. Maria Clinica Medica Servizio Oncologico
      • Torino, Italy
        • A.O.San Giovanni Battista
      • Tricase (LE), Italy
        • A.O.Cardinale Panico Ematologia e centro trapianti
      • Trieste, Italy
        • Azienda Ospedaliera Ospedali riuniti di Trieste
      • Varese, Italy
        • Ospedale di Circolo e Fondazione Macchi
      • Venezia, Italy
        • O.C.SS. Giovanni e Paolo - U.O. Ematologia

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histological DIAGNOSIS of B cell follicular lymphoma
  2. ECOG performance status 0-2
  3. Age range 18-75
  4. Ann Arbor Stage: II-IV
  5. Assessment of pathology with diagnostics biopsy

  6. Presence of one of these criteria:

    • B Sistemic symptoms B
    • Extranodale pathology
    • Cytopenia
    • Splenomegaly
    • Leukemia
    • Serous effusion
    • Ves > 20 mm/h
    • Ldh > normal value
    • Nodale or extranodal mass > 7 cm
    • 3 or more nodal sites > 3 cm
    • Adenopatic syndrome
  7. LVEF > 50%
  8. Normal hepatic (bilirubin < 1.5 mg/dl) and renal functionality (creatinin < 2 mg/dl). If there is a lymphoma it's allow values of bilirubin > 1.5 mg/dl and of creatinin > 2mg/dl
  9. No previous treatment for follicolar lymphoma unless RT-IF
  10. Lifetime > 6 mounth
  11. Absence of HbsAg, HCV e HIV
  12. Negative Coombs Test
  13. Negative pregnant test
  14. Cotracceptive method during the treatment and the follow three months
  15. Formal written consent
  16. Ability to follow the patients after the treatment for follow up

Exclusion Criteria:

  1. Histological Diagnosis of all type of lymphoma unless Follicularlymphoma, CD20 lymphoma, stage IIIb of follicular lymphoma and high degree lymphoma
  2. Stage I of Ann Arbor scale
  3. Central Nervous system involvement
  4. HIV, HBV OR HCV Positivity
  5. Cardiac Pathology
  6. Positive Coombs Test
  7. Previous chemotherapeutic treatment
  8. Hypersensitivity to antibodyes or other murine proteins
  9. Previous cancer pathology unless in situ cervix and epithelial carcinomas
  10. Other type of infections
  11. Pregnant and nursing woman

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
R-CVP x 3; Restaging if> RP then R-CVP x 5
Drug: R-CVP
Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1, Vincristina: 1,4 mg/mq day 1 Prednisone: 40 mg/mq day 1-5,
Experimental: 2
R-CHOP x 3; Restaging if > RP then R-CHOP x 3 plus 2 Rituximab
Drug: R-CHOP
Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1 Doxorubicina: 50 mg/mq day 1 Vincristina: 1.4 mg/mq day 1 Prednisone: 100 mg/mq day 1-5
Experimental: 3
R-FM x 3; Restaging if > RP then R-FM x 3 plus 2 Rituximab
Drug: R-FM
Rituximab: 375 mg/mq day 1, Fludarabina: 25 mg/mq day 1-3, Mitoxantrone: 10 mg/mq day 1,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the Time to Treatment Failure (TTF)in patients treated with R-CVP, R-CHOP and R-FM.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. -
Time Frame: 3 years
3 years
Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP
Time Frame: 2 years
2 years
Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM.
Time Frame: 2 years
2 years
Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM.
Time Frame: 2 years
2 years
Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM.
Time Frame: 2 years
2 years
Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments.
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Fondazione Italiana Linfomi ONLUS

Investigators

  • Principal Investigator: Massimo Federico, PhD, Azienda Ospedaliero-Universitaria di Modena

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

December 1, 2005

Primary Completion (Actual)

September 1, 2010

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

October 14, 2008

First Submitted That Met QC Criteria

October 16, 2008

First Posted (Estimate)

October 17, 2008

Study Record Updates

Last Update Posted (Estimate)

February 15, 2011

Last Update Submitted That Met QC Criteria

February 14, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIL-FOLL05
  • Eudract Number 2005-005406-24

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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