Vinblastine for Leukoreduction in Newly Diagnosed AML and Hyperleukocytosis

Phase 2

Recruiting

• Conditions: AML; Hyperleukocytosis
• Interventions: Drug: Hydroxyurea capsules; Drug: Vinblastine

• Registration Number: NCT05062278
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Brief 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.

Study Timeline

• Study Start: 2021-07-26
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-09
• Last Update Posted: 2021-10-18
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Age >18 years
2. Both genders
3. Diagnosis of non-M3 AML by the WHO 2016 diagnostic criteria
4. Patients eligible and not eligible for transplant
5. Patients eligible and not eligible for intensive treatment
6. AML secondary to treatment or associated to myelodisplasia
7. Leukocytes ≥50x106/L
8. Not being able to receive chemotherapy in the next two days

Exclusion Criteria

1. AML with PMP/RAR-alfa translocation t(15;17)
2. Poor functional status (ECOG>2)
3. Active infection
4. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Hydroxiurea	Hydroxyurea capsules	Patient will recieve oral hydroxiurea at a dose of 50mg/kg/day until response or administration of induction chemotherapy
Intravenous Vinblastine	Vinblastine	Single dose intravenous vinblastine (6mg/m2) in bolous.

Primary Outcome Measures

Name	Time	Method
The proportion of patients with a significant reduction in the number of leukocytes by complete blood count	2 days	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.

Secondary Outcome Measures

Name	Time	Method
Time to achieve a significant reduction in leukocyte count by complete blood count	5 days	Document time for effective leukoreduction by complete blood count after each intervention (defined as a reduction of \>50% of leukocytes after intervention).
Description of daily leukocytes by complete blood count after intervention	5 days	Document daily changes in the number of leukocytes by complete blood count after the administration of intravenous vinblastine or oral hydroxyurea.

Trial Locations

Locations (1)

Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer; 🇲🇽 Monterrey, Nuevo Leon, Mexico