Vinblastine can leukoreduce patients with newly diagnosed AML and hyperleukocytosis but clinical trials are lacking.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Single-dose of intravenous vinblastine at 6mg/m2 (maximum 10mg).
Oral hydroxyurea at a dose of 50mg/kg/day until the administration of induction chemotherapy.
Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer
Monterrey, Nuevo León, Mexico
RECRUITINGThe proportion of patients with a significant reduction in the number of leukocytes by complete blood count
The proportion of patients with a reduction in the number of leukocytes higher than 50% by complete blood count at 48 hours after the intervention.
Time frame: 2 days
Description of daily leukocytes by complete blood count after intervention
Document daily changes in the number of leukocytes by complete blood count after the administration of intravenous vinblastine or oral hydroxyurea.
Time frame: 5 days
Time to achieve a significant reduction in leukocyte count by complete blood count
Document time for effective leukoreduction by complete blood count after each intervention (defined as a reduction of \>50% of leukocytes after intervention).
Time frame: 5 days
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