Last updated 3 years ago
Vinblastine for Leukoreduction in Newly Diagnosed AML and Hyperleukocytosis
46 patients around the world
Available in Mexico
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.
Hospital Universitario Dr. Jose E. Gonzalez
1Research sites
46Patients around the world
This study is for people with
Leukemia
Acute myeloid leukemia
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Age >18 yearsBoth gendersDiagnosis of non-M3 AML by the WHO 2016 diagnostic criteriaPatients eligible and not eligible for transplantPatients eligible and not eligible for intensive treatmentAML secondary to treatment or associated to myelodisplasiaLeukocytes ≥50x106/LNot being able to receive chemotherapy in the next two days
- AML with PMP/RAR-alfa translocation t(15;17)Poor functional status (ECOG>2)Active infectionPregnancy
Sites
Hospital Universitario Dr. José Eleuterio González
Recruiting
SponsorHospital Universitario Dr. Jose E. Gonzalez
Study typeInterventional
Conditions
Acute myeloid leukemia
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05062278
