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Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy

NCT00790036 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 742

Last updated 2017-07-12

Study results available
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Summary

Phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients had achieved complete response with first-line rituximab-chemotherapy

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

DRUG

Everolimus

Everolimus was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.

DRUG

Everolimus Placebo

Everolimus placebo was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-24
Primary Completion
2016-06-15
Completion
2016-06-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Canada
  • China
  • Colombia
  • Czechia
  • Egypt
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Japan
  • Lebanon
  • Mexico
  • New Zealand
  • Norway
  • Peru
  • Poland
  • Russia
  • Saudi Arabia
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Switzerland
  • Thailand
  • Turkey (Türkiye)
  • Venezuela

Study Locations

More Related Trials

Entities

Drugs
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 NCT00790036 on ClinicalTrials.gov