drugset / Trial / NCT02190695

Leukemia SPORE Phase II DAC Study for R/R and Elderly Acute AML and MDS

NCT02190695 ↗

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to find a new way to treat Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML). All the drugs are used to treat AML and MDS but are not usually combined together. The investigators are looking at both the safety and Efficacy of each combination.

Timeline

Start
2013-04-01
Primary completion
2018-06-26
Completion
2020-04-16

Outcome

Met primary endpoint

paper Response rates were 26.7% for DAC alone, 14.3% for DAC/Carbo, and 32.3% for DAC/ATO, with DAC/ATO achieving significantly higher responses (P = .041) PMID 40453133 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — Intravenous
Subject Decitabine Small molecule 20 mg/m2 Intravenous
Subject arsenic trioxide Small molecule 0.15 mg/kg Intravenous