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Vinblastine for Leukoreduction in Newly Diagnosed AML and Hyperleukocytosis

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez (Other)
Overall Status
Recruiting
CT.gov ID
NCT05062278
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
52.2
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients with newly diagnose AML will be allocated 1:1 to recieve single dose vinblastine or daily oral hydroxiureaPatients with newly diagnose AML will be allocated 1:1 to recieve single dose vinblastine or daily oral hydroxiurea
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Vinblastine Versus Oral Hydroxiurea in Newly Diagnosed AML With Hyperleukocytosis: a Phase 2 Clinical Study
Actual Study Start Date :
Jul 26, 2021
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intravenous Vinblastine

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

Drug: Vinblastine
Single-dose of intravenous vinblastine at 6mg/m2 (maximum 10mg).
Other Names:
  • Blestinib

    		•
    Active Comparator: Oral Hydroxiurea

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

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer Monterrey Nuevo Leon Mexico 64460

    Sponsors and Collaborators

    • Hospital Universitario Dr. Jose E. Gonzalez

    Investigators

    • Principal Investigator: David Gomez, Universidad Autonoma de Nuevo Leon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    David Gomez Almaguer, Head of Hematology Department, Hospital Universitario Dr. Jose E. Gonzalez
    ClinicalTrials.gov Identifier:
    NCT05062278
    Other Study ID Numbers:
    • HE21-00019
    First Posted:
    Sep 30, 2021
    Last Update Posted:
    Oct 18, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Hydroxyurea
    Vinblastine

    Study Results

    No Results Posted as of Oct 18, 2021