Clinical Trials Directory

A Phase 2 Study of Decitabine in Combination With Midostaurin (PKC412) for Elderly Patients With Newly Diagnosed FLT3-ITD/TKD Positive Acute Myeloid Leukemia

This phase 2 study evaluates the sequential combination of decitabine then midostaurin for the treatment of newly-diagnosed acute myeloid leukemia (AML) in older patients.

Stanford is not currently accepting new patients for this trial. You may want to check to see if other locations are recruiting.



  • drug : midostaurin
  • drug : decitabine

Phase: Phase 2


Ages Eligible For Study:

60 Years - N/A

Inclusion Criteria

- Newly-diagnosed acute myeloid leukemia (AML) per the World Health Organization [WHO] 2008 classification [except t(15;17)], including: - De novo AML - Secondary AML - Secondary AML arising from previously-diagnosed myelodysplastic syndromes (MDS) treated with deoxyribonucleic acid (DNA) methyltransferase inhibitor (DNMTi) (ie, decitabine or azacitidine) - FLT3-ITD mutation confirmed in bone marrow aspirate - Eastern Cooperative Oncology Group (ECOG) performance status ? 2 - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 x upper limit of normal (ULN) - Serum bilirubin ? 2.5 ULN - Serum creatinine ? 1.5 mg/dL and/or creatinine clearance ? 50 mL/min - Ejection fraction ? 50% by echocardiogram - Unwillingness or inability to receive conventional chemotherapy - Ability to understand and the willingness to sign a written informed consent document - Ability to adhere to the study visit schedule and other protocol requirements - Life expectancy > 2 months

External Links

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jack Taw
Not Recruiting

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