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Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP

NCT01122472 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2021-07-26

No results posted yet for this study

Summary

This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival (PFS) in patients treated with R-CHOP responding to induction therapy

For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs 73.6%), is considered clinically relevant.

Conditions

  • Lymphoma
  • Diffuse Large B-cell Lymphoma

Interventions

DRUG

Lenalidomide

Daily for 3 weeks every 4 weeks for 24 months

DRUG

Placebo

Daily for 3 weeks every 4 weeks for 24 months

Sponsors & Collaborators

  • The Lymphoma Academic Research Organisation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2016-06-30
Completion
2019-09-30

Countries

  • Australia
  • Austria
  • Belgium
  • France
  • Israel
  • Poland
  • Portugal
  • Spain
  • Switzerland

Study Locations

More Related Trials

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 NCT01122472 on ClinicalTrials.gov