NCT04296214

Pharmacoeconomics in the Application of 5-azacitidine in the Treatment of Myelodysplastic Syndromes and Acute Myeloid Leukemia

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Grupo Cooperativo de Hemopatías Malignas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators want to compare the global response rate of patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) after six months of treatment with 5-azacitidine on two different doses. First group of 50 mg/m2 for 10 days each 28 days versus 75 mg/m2 for 7 days on 28 days cycles.

Detailed description

5-Azacitidine it's the standard treatment for patients with MDS and it is widely used for AML in patients that aren't fit for intensive treatment. The standard dose of azacitidine is 75 mg/m2 for 7 días on 28 days cycles. Nevertheless there are studies of pharmacokinetics that have showed there is no difference on plasmatic distribution between 25, 50, 75 or 100 mg/m2 with similar concentration curves. The actual presentation of azacitidine is 100 mg per bottle with less of 24 hours of utility after opened. Looking for optimizations on the use of 5-azacitidine, we have changed the dosing to 50 mg/m2 for 10 days on 28 days cycles with a total dose application of 95% of the traditional regimen with the saving of 5 bottles of the drug.

Conditions

• Myelodysplastic Syndromes
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	5-azacitidine	Cycles of 28 days

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-12-31
• Completion: 2022-03-15
• First posted: 2020-03-05
• Last updated: 2021-07-09

Locations

1 site across 1 country: Mexico