drugset / Trial / NCT02084563

Study of Molecular and Genetic Abnormalities in Patients With Myeloid Neoplasms

NCT02084563

Phase 2 Completed 455 enrolled Hospital Israelita Albert Einstein
Non-randomizedParallel-groupOpen-labelBasic science

Summary

The objective of this study is to describe the prevalence and prognostic impact of the most common genetic abnormalities in patients with Myeloid Neoplasms, including Acute Myeloid Leukemia (AML), Myeloproliferative Neoplasms (MPN), Myelodysplastic Syndromes (MDS) and Myeloproliferative/Myelodysplastic Neoplasms. Patients will have samples of blood and/or bone marrow collected and sent to Hospital Israelita Albert Einstein for analysis and storage. Patients with a diagnosis of Acute Myeloid Leukemia will be treated according to an uniform protocol.

Timeline

Start
2012-10
Primary completion
2014-12
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 40 mg/m2 Intravenous
Subject Cytarabine Small molecule 200 mg/m2 Intravenous
Subject Cytarabine Small molecule 1500 mg/m2 Intravenous
Subject Daunorubicin Small molecule 90 mg/m2 Intravenous
Subject Decitabine Small molecule 20 mg/m2 Intravenous
Background Busulfan Small molecule 1 mg/kg Oral
Background Busulfan Small molecule 130 mg/m2 Oral
Background Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Background Fludarabine Small molecule 40 mg/m2 Intravenous