Acute Myeloid Leukemia (AML)Phase 2PILNCT05291390
Pyronaridine in Acute Myeloid Leukemia (AML)
A Phase 2 study testing Pyronaridine Tetraphosphate in people with Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL), run by Armaceutica, Inc. at 1 site in Senegal.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL)
- What is being tested?
- Pyronaridine Tetraphosphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSenegal
- Study dates
- 21 Feb 2028to Mar 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must have a diagnosis within 60 days of the time of study entry of either acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML). If the physician is a third-party physician, then the study site must obtain the subject's medical records from the clinic where the first diagnosis was made.
- Subjects must be on standard of care therapy for ALL or AML. The standard of care therapy may be initiated at time of study entry.
- Subjects must be 18 years of age or older, and male or female.
- Subjects must weigh between 40kg and 90kg at time of study entry.
- Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) at least 14 days prior to study entry, for the duration of study participation, and at least 30 days after completion of drug administration. Women of child-bearing potential must agree to pregnancy tests for the duration of the study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the study subject should inform her investigator immediately.
- Men must agree to always use a condom during intercourse for the duration of study participation, and for at least 30 days after completion of drug administration.
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- Subjects must have the ability to swallow size "0" gelatin capsules.
- Subject must be willing to agree to and comply with all requirements of the study.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Subjects with malaria.
- Subjects who are pregnant or nursing.
- Subjects who have had major surgery within 30 days prior to study entry.
- Subjects with active clinically significant infection or uncontrolled illness, except ALL or AML.
- Subjects with evidence of chronic hepatitis B (HBV) infection.
- Subjects with evidence or history of hepatitis C (HCV) infection.
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- Subjects with a prior or concurrent malignancy (basal cell carcinoma and squamous cell skin cancer are allowed).
- Subjects with evidence of other disease or any concomitant medical or psychiatric problem which in the opinion of the investigator would put them at risk.
- Subjects with a known hypersensitivity to pyronaridine tetraphosphate or compounds of similar chemical composition, or microcrystalline cellulose (MCC) the placebo agent.
- Subjects who are receiving any other investigational agents or who have received any investigational medication within the past 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a, Multi-center, Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Pyronaridine as an Add-on Therapy in Adults With Acute Myeloid Leukemia
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.
Read the detailed 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.
- Being tested
- Pyronaridine Tetraphosphate
- Keywords
- cancer, leukemia, phase 2, pyronaridine, oncology, treatment
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasms, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyronaridine TetraphosphateDrug
Also called Placebo
Via oral capsules.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care treatment plus pyronaridine | Active comparator | Standard of care treatment plus pyronaridine Receives: Drug: Pyronaridine Tetraphosphate |
| Standard of care treatment plus placebo | Placebo comparator | Standard of care treatment plus placebo Receives: Drug: Pyronaridine Tetraphosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start21 Feb 2028 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionMar 2030 (estimated)
Why it stopped: Change of protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armaceutica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- African Center for Cancer Research and End of Life Care (ACREOL), Rwanda, Ifakara Health Research and Development Centre, Dalal Jamm Hospital, Dakar, Senegal
- Responsible party
- Sponsor
- Investigators
- Renato J Aguilera, PhD, Study chair, Armaceutica, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291390
- Sponsor's protocol ID
- PND7355
- Acronym
- PIL
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2021
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided