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ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)

NCT00662948 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2020-04-28

No results posted yet for this study

Summary

After conventional induction treatment with R-CHOP (Rituximab, cyclophosphamide, adriamycin, vincristine and prednisone) the patients are randomized to:

A: Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg

B: Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months

Conditions

Interventions

DRUG

Rituximab

375 mg/m2 every 8 weeks during 24 months

DRUG

Ibritumomab tiuxetan

One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg

Sponsors & Collaborators

  • GELCAB

    collaborator OTHER

  • Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

    collaborator OTHER

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • Canales Miguel, Dr · Hospital La Paz

  • Lopez-Guillermo Armando, Dr · Hospital Clinic of Barcelona

  • Tomas Jose Francisco, Dr · MD Anderson- Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2014-10-31
Completion
2017-10-30

Countries

  • Spain

Study Locations

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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 NCT00662948 on ClinicalTrials.gov