Status:
WITHDRAWN
Pharmacoeconomics in the Application of 5-azacitidine in the Treatment of Myelodysplastic Syndromes and Acute Myeloid Leukemia
Lead Sponsor:
Grupo Cooperativo de Hemopatías Malignas
Conditions:
Myelodysplastic Syndromes
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
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 diff...
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 dí...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Previous treatment for MDS or AML with chemotherapy or another antineoplastics including hypomethylating agents.
- Acute promyelocytic leukemia
Key Trial Info
Start Date :
January 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04296214
Start Date
January 1 2020
End Date
March 15 2022
Last Update
July 9 2021
Active Locations (1)
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1
Grupo Cooperativo de Hemopatías Malignas
Huixquilucan, State of Mexico, Mexico, 52763