Overview
Vinblastine can leukoreduce patients with newly diagnosed AML and hyperleukocytosis but clinical trials are lacking.
Description
This phase 2 trial will explore the efficacy of a single dose of vinblastine (6mg/m2) to leukoreduce patients with newly diagnosed AML and hyperleukocytosis. Patients will be allocated 1:1 into two groups: intravenous single dose vinblastine or oral hydroxiurea (50mg/kg/day until response or induction chemotherapy). Effective leukoreduction and safety parameters will be compared.
Eligibility
Inclusion Criteria:
- Age >18 years
- Both genders
- Diagnosis of non-M3 AML by the WHO 2016 diagnostic criteria
- Patients eligible and not eligible for transplant
- Patients eligible and not eligible for intensive treatment
- AML secondary to treatment or associated to myelodisplasia
- Leukocytes ≥50x106/L
- Not being able to receive chemotherapy in the next two days
Exclusion Criteria:
- AML with PMP/RAR-alfa translocation t(15;17)
- Poor functional status (ECOG>2)
- Active infection
- Pregnancy