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

• Status: Completed
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to test if combination of sorafenib and omacetaxine mepesuccinate (OM, also known as homoharringtonine) results in durable composite complete remission (CRc) in patients with newly diagnosed or relapsed/refractory (R/R) acute myeloid leukemia (AML) carrying FLT3-ITD (Fms-Like Tyrosine Kinase 3 - Internal Tandem Duplication).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Homoharringtonine; Sorafenib

Criteria

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 ≤1.5×upper 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 ≤1.5×ULN.

10. Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5×ULN.

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.