A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas

NCT ID: NCT01153971

Last Updated: 2017-08-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-20

Study Completion Date

2010-09-24

Brief Summary

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This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.

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

Intervention Type DRUG

1

Interventions

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rituximab

1

Intervention Type DRUG

Other Intervention Names

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MabThera/Rituxan

Eligibility Criteria

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Inclusion Criteria

* adult patients 18-65 years of age;
* previously untreated indolent nonfollicular non-Hodgkin's lymphoma;
* active disease;
* \>=3 involved sites.

Exclusion Criteria

* typical chronic lymphocytic leukemia;
* other malignancies within 3 years before study, except basal or squamous cell skin cancer or cancer in situ of the cervix;
* systemic corticosteroid use for \>1 month;
* significant cardiovascular disease;
* central nervous system involvement;
* hepatitis B or C virus infection, or HIV infection.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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

Ospedale Civile; Divisione Di Oncologia

Pescara, Abruzzo, Italy

Site Status

Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia

Rionero in Vulture, Basilicate, Italy

Site Status

Ospedale Riuniti; Divisione Di Ematologia

Reggio Calabria, Calabria, Italy

Site Status

A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica

Modena, Emilia-Romagna, Italy

Site Status

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

Reggio Emilia, Emilia-Romagna, Italy

Site Status

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

Rome, Lazio, Italy

Site Status

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

Brescia, Lombardy, Italy

Site Status

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

Milan, Lombardy, Italy

Site Status

Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

Milan, Lombardy, Italy

Site Status

Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia

Alessandria, Piedmont, Italy

Site Status

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

Cuneo, Piedmont, Italy

Site Status

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

Turin, Piedmont, Italy

Site Status

Az. Osp. Papardo; Struttura Complessa Di Ematologia

Messina, Sicily, Italy

Site Status

Az. Osp. Di Careggi; Divisione Di Ematologia

Florence, Tuscany, Italy

Site Status

Countries

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Italy

Other Identifiers

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ML18324

Identifier Type: -

Identifier Source: org_study_id

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