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BSH19‐OR‐001 : Efficacy and Safety of CPX‐351 Versus 7+3 In a Subgroup of Older Adults With Newly Diagnosed Acute Myeloid Leukemia With Myelodysplasia‐Related Changes (AML‐MRC) Enrolled In A Phase 3 Study

Researchers

Presenter

  • D.H. Ryan

Principal Investigators

  • L.F. Newell

  • S.A. Strickland

  • D. Hogge

  • R.M. Stone

  • G.J. Schiller

  • A. Legg

  • R.J. Ryan

  • M. Chiarella

  • J.E. Cortes

Medical Centers

  • University of Rochester, Rochester, NY

  • Oregon Health and Science University, Portland, OR

  • Vanderbilt Ingram Cancer Centre,Nashville,United States

  • Leukemia/Bone Marrow Transplant Program of British Columbia, Vancouver, BC, Canada

  • Dana-Farber Cancer Institute, Boston, MA

  • David Geffen School of Medicine at UCLA, Los Angeles, California, United States

  • Jazz Pharmaceuticals,Oxford,United Kingdom

  • Jazz Pharmaceuticals, Palo Alto, CA

  • The University of Texas MD Anderson Cancer Canter, Houston, TX

Locations

  • United States

  • Canada

  • United Kingdom

Companies

  • N/A

Study Components

Therapeutic Area

  • Cardiovascular (CVS)

  • Infectious Diseases (ID)

  • Blood/haematological Diseases

  • Oncology (ONC)

Disease

  • Myeloid neoplasms

  • Alpha-thalassemia myelodysplasia syndrome

  • Acute myelocytic leukemia

  • Congestive heart failure

  • Myelodysplastic Syndrome

  • Heart muscle disease

  • Neutropenia

  • Sepsis

  • Chronic myelomonocytic leukemia

Biomarkers

  • Nucleophosmin 1

  • Cancer antigen 15-3

  • CCAAT enhancer binding protein alpha

  • Hematocrit

  • Tyrosine 3-Monooxygenase/Tryptophan 5-Monooxygenase Activation Protein Epsilon

Drug/Treatment

  • Daunorubicin

  • Cytarabine liposomal

  • daunorubicin + cytarabine

Outcome

  • N/A


Study Design

  • Randomized

  • Multiple Arm

Phase

  • III

Study Id's

  • NCT01696084

Sponsors

  • N/A

Result

  • N/A