A Phase 2 interventional study of Pyronaridine Tetraphosphate in Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL), sponsored by Armaceutica, Inc.. Suspended at 1 site in Senegal. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Armaceutica, Inc. · Phase 2, Interventional, and Treatment
Change of protocol
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.
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.
3,035 studies on the registry are indexed under Leukemia, Myeloid, Acute; 746 are open to participants now.
This study's planned enrollment of 200 is above the median of 40 across 2,561 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →This is the only study on the registry with Armaceutica, Inc. as lead sponsor.
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Exclusion Criteria:
Standard of care treatment plus pyronaridine
Drug: Pyronaridine Tetraphosphate
Standard of care treatment plus placebo
Drug: Pyronaridine Tetraphosphate
Via oral capsules.
Also known as: Placebo
Change in survival lengths to 1 year
The primary endpoint is the change 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 known acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) diagnosis within 60 days of the time of study entry.
Time frame: 1 year
Plan to share: Undecided
Change of protocol
Change of protocol
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is suspended, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pyronaridine