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Study of Zevalin Versus Observation in Participants at Least 60 Years Old With Newly Diagnosed Diffuse Large B-cell Lymphoma in Positron Emission Tomography (PET)-Negative Complete Remission After Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like Therapy

NCT01510184 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2021-12-16

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy.

Conditions

  • Diffuse Large B-cell Lymphoma
  • Follicle Center Lymphoma

Interventions

DRUG

Zevalin

Zevalin administered intravenous infusion.

DRUG

Y-90-Zevalin

Y-90-Zevalin administered by intravenous infusion.

DRUG

Rituximab

Rituximab administered by intravenous infusion.

DRUG

In-111 Zevalin

In-111-Zevalin administered by intravenously.

Sponsors & Collaborators

  • 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
2012-04-19
Primary Completion
2014-10-23
Completion
2014-10-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT01510184 on ClinicalTrials.gov