Vinblastine for Leukoreduction in Newly Diagnosed AML and Hyperleukocytosis

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase: Enrolling; Phase 2

Conditions: AML; Hyperleukocytosis

Treatments: Drug: Vinblastine; Drug: Hydroxyurea capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT05062278

HE21-00019

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

46 participants in 2 patient groups

Intravenous Vinblastine

Experimental group

Description:

Single dose intravenous vinblastine (6mg/m2) in bolous.

Treatment:

Drug: Vinblastine

Oral Hydroxiurea

Active Comparator group

Description:

Patient will recieve oral hydroxiurea at a dose of 50mg/kg/day until response or administration of induction chemotherapy

Treatment:

Drug: Hydroxyurea capsules