CLINICAL TRIAL SUMMARY

MDACC Study No:2009-0467 (clinicaltrials.gov NCT No: NCT01038635)
Title:Phase I/II Study of the Combination of 5-azacitidine with Lenalidomide in Patients with High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
Principal Investigator:Guillermo Garcia-Manero
Treatment Agent:5-Azacytidine; Lenalidomide
Study Status:Closed
Study Description:The goal of Phase 1 of this clinical research study is to find the highest
tolerable dose of lenalidomide that can be given in combination with
azacitidine to patients with MDS or AML.

The goal of Phase 2 of this study is to learn if the combination dose of
azacitidine and lenalidomide found in Phase 1 can help to control MDS and/or
AML.

The safety of this drug combination will be studied in both Phases.

Hide details for General InformationGeneral Information

Disease Group:Leukemia
Phase of Study:Phase I/Phase II
Treatment Agents:5-Azacytidine
Lenalidomide
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:All patients will be registered through CORe. All 5-azacytidine courses will
be given at M.D. Anderson Cancer Center, either as in-patient or out-patient.
Supported By:Celgene Corporation
Return Visit:Weekly
Home Care:Lenalidomide will be self-administered


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Guillermo Garcia-Manero
Dept:Leukemia
For Clinical Trial Enrollment:713-745-3428
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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