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A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)

NCT ID: NCT01144364

Last Updated: 2017-08-15

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-19

Study Completion Date

2011-07-21

Brief Summary

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This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

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Detailed Description

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Conditions

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Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

rituximab [Mabthera/Rituxan]

Intervention Type DRUG

Intravenous repeating dose

Interventions

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rituximab [Mabthera/Rituxan]

Intravenous repeating dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients 60-75 years of age;
* B-cell follicular NHL;
* no previous treatment;
* active disease, with rapid progression.

Exclusion Criteria

* other cancer within 3 years of study, except carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ of the breast treated with lumpectomy;
* long-term use (\>1 month) of systemic corticosteroids;
* central nervous system involvement;
* history of significant cardiovascular disease;
* positive test result for HIV, or hepatitis B or C.
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

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Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia

Pescara, Abruzzo, Italy

Site Status

Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica

Bari, Apulia, Italy

Site Status

IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo

San Giovanni Rotondo, Apulia, Italy

Site Status

Ospedale Riuniti; Divisione Di Ematologia

Reggio Calabria, Calabria, Italy

Site Status

Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica

Napoli, Campania, Italy

Site Status

Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia

Napoli, Campania, Italy

Site Status

Ospedale Cardarelli; Divisione Di Ematologia

Napoli, Campania, Italy

Site Status

Presidio Ospedaliero Umberto I; U.O. Di Medicina Interna Ed Oncoematologia

Nocera Inferiore, Campania, Italy

Site Status

A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

Bologna, Emilia-Romagna, Italy

Site Status

A.O. Universitaria Policlinico Di Modena; Ematologia

Modena, Emilia-Romagna, Italy

Site Status

A.O. Universitaria Policlinico Di Modena; Radiologia

Modena, Emilia-Romagna, Italy

Site Status

Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia

Piacenza, Emilia-Romagna, Italy

Site Status

Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia

Ravenna, Emilia-Romagna, Italy

Site Status

Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia

Reggio Emilia, Emilia-Romagna, Italy

Site Status

Policlinico Universitario; Clinica Oncologia - Padiglione Pennato

Udine, Friuli Venezia Giulia, Italy

Site Status

Ospedale S. Eugenio; Divisione Di Ematologia

Rome, Lazio, Italy

Site Status

Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA

Rome, Lazio, Italy

Site Status

Uni Cattolica; Divisione Di Ematologia

Rome, Lazio, Italy

Site Status

ASST PAPA GIOVANNI XXIII; Ematologia

Bergamo, Lombardy, Italy

Site Status

A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia

Brescia, Lombardy, Italy

Site Status

ASST DI CREMONA; U.O.S. di Ematologia

Cremona, Lombardy, Italy

Site Status

Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora

Milan, Lombardy, Italy

Site Status

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

Milan, Lombardy, Italy

Site Status

Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico

Milan, Lombardy, Italy

Site Status

Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

Milan, Lombardy, Italy

Site Status

ASST DI MONZA; Ematologia

Monza, Lombardy, Italy

Site Status

Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia

Alessandria, Piedmont, Italy

Site Status

Az. Osp. Di Biella; Divisione Di Ematologia

Biella, Piedmont, Italy

Site Status

Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

Candiolo, Piedmont, Italy

Site Status

Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia

Cuneo, Piedmont, Italy

Site Status

Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

Orbassano, Piedmont, Italy

Site Status

A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1

Turin, Piedmont, Italy

Site Status

A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia

Turin, Piedmont, Italy

Site Status

Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.

Cagliari, Sardinia, Italy

Site Status

Az. Osp. Papardo; Struttura Complessa Di Ematologia

Messina, Sicily, Italy

Site Status

Ospedale V. Cervello; U.O. Ematologia E Trapianti

Palermo, Sicily, Italy

Site Status

Ospedale Ferrarotto; Divisione Di Ematologia

Via S. Sofia 78, Sicily, Italy

Site Status

Ospedale Regionale Di Torrette; Clinica Di Ematologia

Ancona, The Marches, Italy

Site Status

Ospedale Civile; S.C. Ematologia

Pesaro, The Marches, Italy

Site Status

Azienda Sanitaria Di Bolzano; Ematologia E Centro Trapianto Mid.Osseo

Bolzano, Trentino-Alto Adige, Italy

Site Status

Az. Osp. Di Careggi; Divisione Di Ematologia

Florence, Tuscany, Italy

Site Status

Ospedale Santa Chiara; Unita Operativa Di Ematologia

Pisa, Tuscany, Italy

Site Status

Dept. Medicina Clinica E Sperimentale; Sez. Medicina Interna E Scienze Oncologiche - Pol. Monteluce

Perugia, Umbria, Italy

Site Status

Ospedale Civile Ss. Giovanni E Paolo; Ematologia

Venezia, Veneto, Italy

Site Status

Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia

Verona, Veneto, Italy

Site Status

Countries

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Italy

References

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Ladetto M, Lobetti-Bodoni C, Mantoan B, Ceccarelli M, Boccomini C, Genuardi E, Chiappella A, Baldini L, Rossi G, Pulsoni A, Di Raimondo F, Rigacci L, Pinto A, Galimberti S, Bari A, Rota-Scalabrini D, Ferrari A, Zaja F, Gallamini A, Specchia G, Musto P, Rossi FG, Gamba E, Evangelista A, Vitolo U; Fondazione Italiana Linfomi. Persistence of minimal residual disease in bone marrow predicts outcome in follicular lymphomas treated with a rituximab-intensive program. Blood. 2013 Nov 28;122(23):3759-66. doi: 10.1182/blood-2013-06-507319. Epub 2013 Oct 1.

Reference Type DERIVED
PMID: 24085766 (View on PubMed)

Vitolo U, Ladetto M, Boccomini C, Baldini L, De Angelis F, Tucci A, Botto B, Chiappella A, Chiarenza A, Pinto A, De Renzo A, Zaja F, Castellino C, Bari A, Alvarez De Celis I, Evangelista A, Parvis G, Gamba E, Lobetti-Bodoni C, Ciccone G, Rossi G. Rituximab maintenance compared with observation after brief first-line R-FND chemoimmunotherapy with rituximab consolidation in patients age older than 60 years with advanced follicular lymphoma: a phase III randomized study by the Fondazione Italiana Linfomi. J Clin Oncol. 2013 Sep 20;31(27):3351-9. doi: 10.1200/JCO.2012.44.8290. Epub 2013 Aug 19.

Reference Type DERIVED
PMID: 23960180 (View on PubMed)

Other Identifiers

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ML17638

Identifier Type: -

Identifier Source: org_study_id

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