Using vinblastine to reduce white blood cell counts in newly diagnosed AML patients
Vinblastine Versus Oral Hydroxiurea in Newly Diagnosed AML With Hyperleukocytosis: a Phase 2 Clinical Study
PHASE2 · Hospital Universitario Dr. Jose E. Gonzalez · NCT05062278
This study tests if a single dose of vinblastine can help lower high white blood cell counts in people who have just been diagnosed with acute myeloid leukemia.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario Dr. Jose E. Gonzalez (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Monterrey, Nuevo Leon) |
| Trial ID | NCT05062278 on ClinicalTrials.gov |
What this trial studies
This phase 2 trial investigates the effectiveness of a single dose of vinblastine in reducing high white blood cell counts in patients with newly diagnosed acute myeloid leukemia (AML) and hyperleukocytosis. Participants will be randomly assigned to receive either vinblastine or hydroxyurea, with the goal of comparing the efficacy and safety of these two treatments. The study aims to provide insights into a potential new approach for managing this condition, which currently lacks sufficient clinical trial data.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with newly diagnosed non-M3 AML and leukocyte counts of 50x10^6/L or higher.
Not a fit: Patients with acute promyelocytic leukemia (APL) or those with poor functional status, active infections, or who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new option for effectively managing high white blood cell counts in AML patients, potentially improving their overall treatment outcomes.
How similar studies have performed: While there is limited clinical trial data specifically on vinblastine for this indication, the approach of leukoreduction in AML has been explored in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Monterrey, Nuevo Leon
- Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer — Monterrey, Nuevo Leon, Mexico (RECRUITING)
Study contacts
- Principal investigator: David Gomez — Universidad Autonoma de Nuevo Leon
- Study coordinator: Andres Gomez
- Email: drgomezdeleon@gmail.com
- Phone: 818470002
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: AML, Hyperleukocytosis