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Clinical Trial Summary

A Phase 2a clinical trial on up to n=200 male and female subjects 18 years and over who were diagnosed with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL). Subjects are randomised in approximately a 1:1 ratio to receive standard of care treatment plus either pyronaridine (PND) or placebo. Quality of life parameters are measured. Visits include physical examinations, and blood draws for complete blood count with differential (CBC) and complete metabolic panel (CMP). Survival of subjects is tracked in Year 2.


Clinical Trial Description

The primary objective is the difference in survival lengths in days between the study arm receiving pyronaridine and the study arm receiving placebo as measured from the date of the first diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL). Secondary objectives are differences between the active and placebo study arms in quality of life, laboratory data values and in the safety and tolerability of treatments. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05291390
Study type Interventional
Source Armaceutica, Inc.
Contact Ernest T Armstrong, MBA
Phone 1(949)677-6001
Email ernest@armaceutica.com
Status Recruiting
Phase Phase 2
Start date November 21, 2022
Completion date March 2024

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