Vinblastine for Leukoreduction in Newly Diagnosed AML and Hyperleukocytosis

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:

1. Age >18 years
2. Both genders
3. Diagnosis of non-M3 AML by the WHO 2016 diagnostic criteria
4. Patients eligible and not eligible for transplant
5. Patients eligible and not eligible for intensive treatment
6. AML secondary to treatment or associated to myelodisplasia
7. Leukocytes ≥50x106/L
8. Not being able to receive chemotherapy in the next two days

Exclusion Criteria:

1. AML with PMP/RAR-alfa translocation t(15;17)
2. Poor functional status (ECOG>2)
3. Active infection
4. Pregnancy