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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05062278

Enrollment

Registered

2021-09-30

Start date

2021-07-26

Completion date

2025-12-01

Last updated

2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML, Hyperleukocytosis

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.

Interventions

DRUGVinblastine

Single-dose of intravenous vinblastine at 6mg/m2 (maximum 10mg).

DRUGHydroxyurea capsules

Oral hydroxyurea at a dose of 50mg/kg/day until the administration of induction chemotherapy.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Patients with newly diagnose AML will be allocated 1:1 to recieve single dose vinblastine or daily oral hydroxiurea

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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).

Countries

Mexico

Contacts

Primary ContactAndres Gomez

drgomezdeleon@gmail.com818470002

Backup ContactPerla Colunga

colunga.perla@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026