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Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma

NCT00641095 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2018-10-31

No results posted yet for this study

Summary

This randomized phase III trial is comparing how well fludarabine and cyclophosphamide work when given together with or without rituximab in treating patients with previously untreated mantle cell lymphoma.

Conditions

Interventions

BIOLOGICAL

rituximab

concentrate for solution for infusion

DRUG

Cyclophosphamide

Tablets

DRUG

Fludarabine

Film coated tablet

Sponsors & Collaborators

Principal Investigators

  • Simon Rule, MD · Derriford Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-12-07
Primary Completion
2011-11-23
Completion
2015-05-22

Countries

  • Australia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00641095 on ClinicalTrials.gov