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Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma

NCT02285062 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2023-06-22

Study results available
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Summary

To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in patients who have previously untreated ABC type DLBCL.

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Interventions

DRUG

lenalidomide

DRUG

Placebo

DRUG

Rituximab

DRUG

Cyclophosphamide

DRUG

Doxorubicin

DRUG

prednisone

DRUG

vincristine

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-02-17
Primary Completion
2019-03-15
Completion
2022-07-28

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • China
  • Czechia
  • France
  • Ireland
  • Israel
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Portugal
  • Puerto Rico
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)

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 NCT02285062 on ClinicalTrials.gov