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Study Comparing Zevalin Regimen With no Further Treatment in Patients With Diffuse Large B-cell Lymphoma.

NCT00322218 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2022-01-19

Study results available
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Summary

This study treats patients with diffuse large B-cell lymphoma whose disease is in complete remission due to previous treatment with Cyclophosphamide Doxorubicin hydrochloride Vincristine Prednisolone- Rituximab (CHOP-R). Half of the patients received Zevalin and the other half receive no further anti-cancer treatment. The two patient groups compared to determine if Zevalin given after CHOP-R therapy provides greater benefits than receiving no additional anti-cancer therapy after CHOP-R.

Conditions

  • Lymphoma, Large Cell, Diffuse

Interventions

DRUG

Zevalin

Zevalin study treatment regimen consisted of 2 rituximab i.v. infusions (Day 1 and Day 7-9) and one \[90Y\]-ibritumomab tiuxetan infusion in connection with the second rituximab infusion. The core treatment regimen in the Zevalin arm was: Day 1: Rituximab i.v. infusion 250 mg/m\^2 Day 7-to 9: Rituximab i.v. infusion 250 mg/m\^2 immediately followed by \[90Y\]-ibritumomab tiuxetan 14.8 MBq/kg (0.4 mCi/kg) with a maximum dose of 1184 MBq (32 mCi),administered as slow intravenous push over 10 minutes.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Spectrum Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Finland
  • France
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Poland
  • Portugal
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00322218 on ClinicalTrials.gov