Vinblastine for Leukoreduction in Newly Diagnosed AML and Hyperleukocytosis

  • STATUS
    Recruiting
  • End date
    Dec 1, 2025
  • participants needed
    46
  • sponsor
    Hospital Universitario Dr. Jose E. Gonzalez
Updated on 24 October 2021
hydroxyurea
induction chemotherapy

Summary

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

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.

Details
Condition Acute Myelogenous Leukemia (AML), Acute Myeloid Leukemia, hyperleukocytosis, acute myelogenous leukemia, acute myeloblastic leukemia, anll, Acute myeloid leukemia
Treatment Vinblastine, Hydroxyurea capsules
Clinical Study IdentifierNCT05062278
SponsorHospital Universitario Dr. Jose E. Gonzalez
Last Modified on24 October 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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