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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 clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : midostaurin
  • drug : decitabine

Phase: Phase 2

Eligibility

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
650-723-2781
Not Recruiting

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