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Non-randomized Safety Study With Bortezomib/Rituximab in Relapsed/Refractory Indolent Lymphoma

NCT00509379 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2011-01-28

No results posted yet for this study

Summary

The promising activity of Bortezomib as single agent in low grade lymphoma patients in small studies has led to a number of larger multicenter trials with Bortezomib in combination with Rituximab in mantle-cell lymphoma, follicular lymphoma and marginal zone lymphoma.

Conditions

Interventions

DRUG

Rituximab

Rituximab 375 mg/m2 as slow iv infusion day 1-8-15-22.Patients will be treated with six courses of therapy with a thirteen day rest period between them. Courses will be restarted at day 36.

DRUG

VELCADE

VELCADE 1,6 mg/m2 iv bolus days 1-8-15-22 (Velcade will be administrated prior of Rituximab infusion).Patients will be treated with six courses of therapy with a thirteen day rest period between them. Courses will be restarted at day 36.

Sponsors & Collaborators

  • Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

    collaborator OTHER

  • Fondazione Italiana Linfomi - ETS

    collaborator OTHER

  • University of Turin, Italy

    collaborator OTHER

  • Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie

    lead OTHER

Principal Investigators

  • Umberto Vitolo, MD · S.C. Ematologia 2 ASO San Giovanni Battista Torino

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2007-11-30
Completion
2011-01-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00509379 on ClinicalTrials.gov