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

Sponsor

Grupo Cooperativo de Hemopatías Malignas (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04296214

Collaborator

(none)

Enrollment

Location

26.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes Acute Myeloid Leukemia	Drug: 5-azacitidine

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.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Mar 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
A Azacitidine 50 mg/m2 for 10 days each 28 days	Drug: 5-azacitidine Cycles of 28 days
B Azacitidine 75 mg/m2 for 7 days each 28 days	Drug: 5-azacitidine Cycles of 28 days

Arm

Intervention/Treatment

Azacitidine 50 mg/m2 for 10 days each 28 days

Drug: 5-azacitidine

Cycles of 28 days

Azacitidine 75 mg/m2 for 7 days each 28 days

Drug: 5-azacitidine

Cycles of 28 days

Outcome Measures

Primary Outcome Measures

Response Rate [6 months]
Global response rate by International Criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥18 years
Confirmed diagnosis of MDS that require treatment with 5-aza characterized by: i) RAEB-1 defined as the presence of 5%-9% of myeloblasts in bone marrow; ii) RAEB-2 defined as the presence of 10%-19% of myeloblasts in bone marrow or 5%-19% blasts in peripheral blood; iii) IPSS-R very high, high or intermediate
Confirmed AML with blasts ≥ 20% in bone marrow or peripheral blood and that its not candidate to receive intense chemotherapy at consideration of the physician.
Performance status of 0, 1 o 2 by the Eastern Cooperative Oncology Group (ECOG).
Availability to sign an informed consent