Clinical trial · Interventional
Combination of Sorafenib and Omacetaxine Mepesuccinate in Newly Diagnosed or Relapsed/Refractory AML Carrying FLT3-ITD
A Phase II Single-arm Open-labeled Study Evaluating Combination of Sorafenib and Omacetaxine Mepesuccinate in Newly Diagnosed or Relapsed/Refractory AML Carrying FLT3-ITD
NCT03170895CI-TRIAL-00044338completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| FLT3-ITD Mutation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omacetaxine Mepesuccinate Injection | Drug | Omacetaxine Mepesuccinate | ALIAS |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sorafenib and Omacetaxine Mepesuccinate
- description
- The starting dose of sorafenib will be 400 mg twice daily. Sorafenib should be taken continuously throughout the treatment period unless there is no evidence of response at first assessment on day 28 or progressive disease at any time during the treatment. OM will be given at 1.5 mg/m2/day (maximum dose 3 mg) for 7 days (concurrently with sorafenib) in 28-day cycle. Sorafenib and OM will be continued until leukemia progression or allogeneic HSCT. Thereafter, patients will be followed up and information about disease status and survival will be collected.
- interventionNames
- Drug: Sorafenib
- Drug: Omacetaxine Mepesuccinate Injection
Primary outcomes (1)
- measure
- Complete remission
- timeFrame
- up to 16 weeks
- description
- No increase in blasts in BM or PB (\<5% of total nucleated cells), with absolute neutrophil count ≥ 1x109/L and platelet count ≥ 100 x109/L
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.