NCT05062278

Vinblastine for Leukoreduction in Newly Diagnosed AML and Hyperleukocytosis

Vinblastine Versus Oral Hydroxiurea in Newly Diagnosed AML With Hyperleukocytosis: a Phase 2 Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Vinblastine can leukoreduce patients with newly diagnosed AML and hyperleukocytosis but clinical trials are lacking.

Detailed 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.

Conditions

• AML
• Hyperleukocytosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-26
• Primary completion: 2025-07-01
• Completion: 2025-12-01
• First posted: 2021-09-30
• Last updated: 2021-10-18

Locations

1 site across 1 country: Mexico

Regulatory

• FDA-regulated drug study