Clincosm LogoSign in Get a demo

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

Sponsor
Fondazione Italiana Linfomi ONLUS (Other)
Overall Status
Unknown status
CT.gov ID
NCT00774826
Collaborator
(none)
534
Enrollment
82
Locations
3
Arms
99
Duration (Months)
6.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
534 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Dec 1, 2005
Actual Primary Completion Date :
Sep 1, 2010
Anticipated Study Completion Date :
Mar 1, 2014

Arms and Interventions

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,

Outcome Measures

Primary Outcome Measures

  1. Assessment of the Time to Treatment Failure (TTF)in patients treated with R-CVP, R-CHOP and R-FM. [2 years]

Secondary Outcome Measures

  1. Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. - [3 years]

  2. Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP [2 years]

  3. Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM. [2 years]

  4. Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM. [2 years]

  5. Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM. [2 years]

  6. Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. LVEF > 50%

  2. 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

  3. No previous treatment for follicolar lymphoma unless RT-IF

  4. Lifetime > 6 mounth

  5. Absence of HbsAg, HCV e HIV

  6. Negative Coombs Test

  7. Negative pregnant test

  8. Cotracceptive method during the treatment and the follow three months

  9. Formal written consent

  10. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ente ecclesiastico Ospedale generale regionale Miulli Acquaviva delle fonti (BA) Italy
2 Az.Ospedaliera SS.Antonio, Biagio e Cesare Arrigo-U.O.A.Ematologia Alessandria Italy
3 Presidio Ospedaliero C.Massaia di Asti Asti Italy
4 Istituto Nazionale Tumori Aviano Italy
5 IRCCS Istituto tumori Giovanni Paolo II Bari Italy
6 Divisione Medicina B Ospedale degli Infermi Biella Italy
7 Policlinico Sant'Orsola - Istituto di Ematologia e Oncologia medica L.e A. Seragnoli Bologna Italy
8 Ospedale di Bolzano Divisione di Ematologia e Centro Trapianti di Midollo Osseo Bolzano Italy
9 A.O.Spedali civili di Brescia Brescia Italy
10 Presidio Ospedaliero A.Perrino Brindisi Italy
11 Ospedale Businco, Divisione di Ematologia Cagliari Italy
12 Ospedale Civile Camposanpiero (PD) Italy
13 Istituto per la ricerca e la cura del cancro Candiolo (TO) Italy
14 A.O. dell'Annunziata Unita' Operativa di Ematologia Carpi (MO) Italy
15 Ospedale Ramazzini Day Hospital Oncologico Carpi (Mo) Italy
16 Ospedale Garibaldi-Nesima Catania Italy
17 Universita' degli studi di Catania Catania Italy
18 A.O. Pugliese A. Ciaccio Catanzaro Italy
19 A.O.Pugliese Ciaccio Diviisone di Ematologia Catanzaro Italy
20 Ospedale civico di Chivasso Chivasso (TO) Italy
21 Ospedale di Ciriè U.O.N.A. Oncologia servizio di Ematologia Ciriè (TO) Italy
22 Ospedale civile Divisione di Ematologia Civitanova Marche (MC) Italy
23 Ospedale San Sebastiano Correggio (RE) Italy
24 Presidio Ospedaliero Annunziata Cosenza Italy
25 Azienda istituti ospedalieri di Cremona Cremona Italy
26 Policlinico Careggi, cattedra e diviisone di Ematologia Firenze Italy
27 E.O.Ospedali Galliera U.O.Ematologia Genova Italy
28 Ospedale San Martino - Divisione di Ematologia Genova Italy
29 Ospedale Felettino reparto di Oncologia La Spezia Italy
30 Ospedale Vito Fazzi Lecce Italy
31 Ospedale A.Manzoni Oncologia medica Lecco Italy
32 Ospedale Madonna delle grazie U.O. Ematologia Matera Italy
33 Azienda Ospedaliera Papardo Messina Italy
34 Policlinico universitario U.O. Ematologia Messina Italy
35 Azienda Ospedaliera Fatebenefratelli e Oftalmico Milano Italy
36 IRCCS San Raffaele Unità di Chemioterapia Milano Italy
37 Osp. San Carlo Borromeo Divisione di Oncologia Medica Milano Italy
38 Ospedale Maggiore IRCCS-Dipartimento di Ematologia Milano Italy
39 Ospedale Niguarda CA' Granda Milano Italy
40 Ospedale San Paolo U.O. Oncologia Medica Milano Italy
41 Policlinico di Modena - Università degli studi Modena Italy
42 Ospedale S. Gerardo Divisione di ematologia Monza (MI) Italy
43 AORN Cardarelli U.O.Ematologia Napoli Italy
44 Ospedale P.F.Calvi dipartimento id Oncologia ed Ematologia Noale Italy
45 Presidio Ospedaliero Umberto I Medicina ed Onco-Ematologia Nocera Inferiore Italy
46 A.O. Maggiore della Carità S.C.D.U. Ematologia Novara Italy
47 A.O. di Padova Divisione di Oncologia Medica Padova Italy
48 Casa di cura La Maddalena Unita' di Ematologia Palermo Italy
49 Policlinico P.Giaccone Palermo Italy
50 Universita' degli studi di Parma Parma Italy
51 Policlinico San Matteo - Medicina generale Pavia Italy
52 Policlinico San Matteo Pavia Italy
53 Policlinico Monteluce Divisione di Ematologia Perugia Italy
54 Ospedale Santo Spirito Dipartimento di Ematologia Pescara Italy
55 Ospedale Santo Spirito-Dipartimento di Oncologia Pescara Italy
56 Ospedale Civile, Sezione di Ematologia Piacenza Italy
57 Ospedale S. Chiara Azienda ospedaliera pisana Pisa Italy
58 Presidio Ospedali riuniti "Bianchi, Melacrino, Morelli" Divisione di ematologia Reggio Calabria Italy
59 Azienda ospedaliera Arcispedale S.Maria Nuova Reggio Emilia Italy
60 Ospedale Oncologico regionale CROB Rionero in Vulture (PZ) Italy
61 A.O.S.Andrea Reparto di Ematologia e Immunoematologia Roma Italy
62 Azienda Policlinico Umberto I - La Sapienza Roma Italy
63 Istituto Regina Elena Roma Italy
64 Ospedale San Giacomo U.O. Ematologia Roma Italy
65 Policlinico A. Gemelli Università Cattolica del Sacro Cuore Roma Italy
66 Policlinico Universitario Campus biomedico Roma Italy
67 Policlinico Universitario Tor Vergata Roma Italy
68 Universita' La Sapienza Roma Italy
69 P.O. Roncilgione U.O. Ematologia Ronciglione (VT) Italy
70 Istituto clinco Humanitas Rozzano (MI) Italy
71 IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo (FG) Italy
72 Istituto di Ematologia Università degli studi di Sassari Sassari Italy
73 Ospedale civile DH oncologico Sassuolo (MO) Italy
74 Ospedale San Paolo Savona Italy
75 A.O. della Valtellina e della Valchiavenna Presidio Ospedaliero di Sondalo Sondalo Italy
76 Azienda Ospedaliera S. Maria Terni Italy
77 Ospedale S. Maria Clinica Medica Servizio Oncologico Terni Italy
78 A.O.San Giovanni Battista Torino Italy
79 A.O.Cardinale Panico Ematologia e centro trapianti Tricase (LE) Italy
80 Azienda Ospedaliera Ospedali riuniti di Trieste Trieste Italy
81 Ospedale di circolo e Fondazione Macchi Varese Italy
82 O.C.SS. Giovanni e Paolo - U.O. Ematologia Venezia Italy

Sponsors and Collaborators

  • Fondazione Italiana Linfomi ONLUS

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00774826
Other Study ID Numbers:
  • IIL-FOLL05
  • Eudract Number 2005-005406-24
First Posted:
Oct 17, 2008
Last Update Posted:
Feb 15, 2011
Last Verified:
Feb 1, 2011
Keywords provided by , ,
Follicular lymphoma
Rituximab
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular

Study Results

No Results Posted as of Feb 15, 2011