Vinblastine for Leukoreduction in Newly Diagnosed AML and Hyperleukocytosis

October 9, 2021 updated by: David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez

Vinblastine Versus Oral Hydroxiurea in Newly Diagnosed AML With Hyperleukocytosis: a Phase 2 Clinical Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Recruiting
        • Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Fernando De la Garza-Salazar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients with a significant reduction in the number of leukocytes by complete blood count
Time Frame: 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.
2 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2021

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

September 20, 2021

First Posted (Actual)

September 30, 2021

Study Record Updates

Last Update Posted (Actual)

October 18, 2021

Last Update Submitted That Met QC Criteria

October 9, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE21-00019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on AML

Clinical Trials on Vinblastine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe