Last updated on March 2019

Combination of Sorafenib and Omacetaxine Mepesuccinate in Newly Diagnosed or Relapsed/Refractory AML Carrying FLT3-ITD


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute myeloid leukemia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Provision of written informed consent approved by the Institutional Review Board (IRB).
  2. Age 18 years
  3. Documented primary AML or AML secondary to myelodysplastic syndrome (MDS), as defined by World Health Organization criteria
  4. At diagnosis or in morphological relapse after an initial remission or refractory after induction chemotherapy, with or without HSCT
  5. Documentation of FLT3-ITD in BM or blood with allelic burden of 20% as determined by the study site laboratory
  6. ECOG performance score 0-2
  7. Serum creatinine 1.5upper limit of normal (ULN), or glomerular filtration rate >25 mL/min, as calculated with the Cockcroft-Gault formula.
  8. Serum potassium, magnesium, and calcium (corrected for albumin) within institutional normal limits. Subjects with electrolytes outside the normal range will be eligible if these values are corrected upon retesting following any necessary supplementation.
  9. Total serum bilirubin 1.5ULN.
  10. Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) 2.5ULN.

Exclusion Criteria:

  1. Acute promyelocytic leukemia (AML subtype M3)
  2. Prior treatment with any FLT3 inhibitors
  3. Known infection with human immunodeficiency virus, or active hepatitis B or C infection.
  4. Refusal of blood product transfusion.
  5. In a man whose sexual partner is a woman of childbearing potential, unwillingness or inability of the man or woman to use an acceptable contraceptive method for the entire study treatment period and for at least 3 months after study treatment completion
  6. In a heterosexually active woman of childbearing potential, unwillingness or inability to use an acceptable contraceptive method for the entire study treatment period and for at least 3 months after study treatment completion
  7. Pregnancy
  8. Female subjects must agree not to breastfeed at screening and throughout the study period, and for 45 days after the final study drug administration.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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