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Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

NCT00921414 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 299

Last updated 2018-04-27

No results posted yet for this study

Summary

Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lymphoma and exhibiting a response after autologous transplantation.

Conditions

Interventions

DRUG

Rituximab

2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years

OTHER

Watch and wait

No treatment patient follow-up every 2 months during 3 years

Sponsors & Collaborators

  • Lymphoma Study Association

    collaborator OTHER

  • French Innovative Leukemia Organisation

    lead OTHER

Principal Investigators

  • Steven LE GOUILL, MD · French Innovative Leukemia Organisation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2008-09-30
Completion
2017-02-28

Countries

  • France

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 NCT00921414 on ClinicalTrials.gov