Vinblastine for Leukoreduction in Newly Diagnosed AML and Hyperleukocytosis
NCT05062278 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2021-10-18
Summary
Vinblastine can leukoreduce patients with newly diagnosed AML and hyperleukocytosis but clinical trials are lacking.
Conditions
- AML
- Hyperleukocytosis
Interventions
- DRUG
-
Vinblastine
Single-dose of intravenous vinblastine at 6mg/m2 (maximum 10mg).
- DRUG
-
Hydroxyurea capsules
Oral hydroxyurea at a dose of 50mg/kg/day until the administration of induction chemotherapy.
Sponsors & Collaborators
-
Hospital Universitario Dr. Jose E. Gonzalez
lead OTHER
Principal Investigators
-
David Gomez · Universidad Autonoma de Nuevo Leon
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-26
- Primary Completion
- 2025-07-01
- Completion
- 2025-12-01
- FDA Drug
- Yes
Countries
- Mexico
Study Locations
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