CLINICAL TRIAL SUMMARY

MDACC Study No:2009-0793 (clinicaltrials.gov NCT No: NCT00790036)
Title:A randomized, double-blind, placebo-controlled, multicenter 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 rituximabchemotherapy
Principal Investigator:Luis E. Fayad
Treatment Agent:RAD001
Study Status:Closed
Study Description:The goal of this clinical research study is to learn if Affinitor (everolimus)
can slow down the growth or prevent the cancer from coming back after
treatment. The safety of everolimus will also be studied.

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Disease Group:Lymphoma
Phase of Study:Phase III
Treatment Agents:RAD001
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:NA
Supported By:Novartis
Return Visit:Screening visit, every month for planned txt duration of 1 year,
end-of-treatment visit that occurs within 7 days after you stop study txt, a
28-day visit, and follow-up tumor assessments every 12 weeks of year 2, every
24 weeks of years 3 and 4.
Home Care:RAD001 or matching placebo will be dispensed on Day 1 of each cycle on an
outpatient basis.Patients will be provided with an adequate supply of RAD001 or
matching placebo for self-administration at home.


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Physician Name:Luis E. Fayad
Dept:Lymphoma/Myeloma
For Clinical Trial Enrollment:713-792-2860
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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