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Brief Title: AEG35156 in Combination With High-dose Cytarabine and Idarubicin in AML Following Failure of a Single Standard Dose Cytarabine Based Frontline Induction Regimen
Official Title: An Open-Label Randomized Phase 2 Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination With High-dose Cytarabine and Idarubicin in AML Following Failure of a Single Standard Dose Cytarabine Based Frontline Induction Regimen
Study ID: NCT01018069
Brief Summary: To determine if AEG35156 can enhance the combined complete remission (CR) and CR with incomplete platelet recovery (CRp) rate of high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UCLA School of Medicine, Los Angeles, California, United States
Rocky Mountain Blood & Marrow Transplant Program, Denver, Colorado, United States
Northwestern University Med School, div. Oncology & Hematology, Chicago, Illinois, United States
New York Medical College, Valhalla, New York, United States
MD Anderson Cancer Center University of Texas, Houston, Texas, United States
Cancer Research Institute of Scott & White Hospital, Temple, Texas, United States
Princess Margaret Hospital, Toronto, Ontario, Canada
Hopital Charles Lemoyne, Greenfield Park, Quebec, Canada
Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada
Hopital Sacre Coeur, Montreal, Quebec, Canada
Klinikum Chemnitz gGmbH, Chemnitz, , Germany
St. Johannes Hospital, Duisburg, , Germany
Universitatsklinimum Essen, Essen, , Germany
Universitatsklinikum Hamburg-Eppendorf, Hamburg, , Germany
2. Medizinische Klinik und Poliklinik im Stadtischen Krankenhaus Kile GmgH, Kiel, , Germany
III. Medizinische Klinik und Poliklinik der Johannes Gutenberg-Universitat, Mainz, , Germany
Medizinische Klinik a Hamatologie und Onkologie, Munster, , Germany
Robert Boasch Krankenhaus Stuttgart, Stuttgart, , Germany
Name: Aaron Schimmer, MD
Affiliation: Princess Margaret Hospital, Canada
Role: PRINCIPAL_INVESTIGATOR