Vinblastine for Leukoreduction in Newly Diagnosed AML and Hyperleukocytosis

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

Detailed Description
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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.

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

Conditions
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AML, Hyperleukocytosis

Intervention / Treatment
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* Drug: Vinblastine
* Drug: Hydroxyurea capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Both genders Diagnosis of non-M3 AML by the WHO 2016 diagnostic criteria Patients eligible and not eligible for transplant Patients eligible and not eligible for intensive treatment AML secondary to treatment or associated to myelodisplasia Leukocytes ≥50x106/L Not being able to receive chemotherapy in the next two days Exclusion Criteria: AML with PMP/RAR-alfa translocation t(15;17) Poor functional status (ECOG>2) Active infection Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with newly diagnose AML will be allocated 1:1 to recieve single dose vinblastine or daily oral hydroxiurea
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous Vinblastine<br>Single dose intravenous vinblastine (6mg/m2) in bolous. | Drug: Vinblastine<br>* Single-dose of intravenous vinblastine at 6mg/m2 (maximum 10mg).<br>* Other names: Blestinib;|
| Active Comparator: Oral Hydroxiurea<br>Patient will recieve oral hydroxiurea at a dose of 50mg/kg/day until response or administration of induction chemotherapy | Drug: Hydroxyurea capsules<br>* Oral hydroxyurea at a dose of 50mg/kg/day until the administration of induction chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 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. | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 5 days |