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SuspendedNCT05291390PILUpdated Oct 19, 2026

Pyronaridine in Acute Myeloid Leukemia (AML)

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

Why this study was suspended
Change of protocol
Updated Oct 19, 2026Now SuspendedStart date moved+3 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Acute Myeloid Leukemia (AML)
  • Acute Lymphoblastic Leukemia (ALL)

Keywords

  • cancer
  • leukemia
  • phase 2
  • pyronaridine
  • oncology
  • treatment
03

In context

Leukemia, Myeloid, Acute

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 →

Lead sponsor

This is the only study on the registry with Armaceutica, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.
  2. 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.
  3. Subjects must be 18 years of age or older, and male or female.
  4. Subjects must weigh between 40kg and 90kg at time of study entry.
  5. 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.
  6. 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.
  7. Subjects must have the ability to swallow size "0" gelatin capsules.
  8. Subject must be willing to agree to and comply with all requirements of the study.
  9. Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with malaria.
  2. Subjects who are pregnant or nursing.
  3. Subjects who have had major surgery within 30 days prior to study entry.
  4. Subjects with active clinically significant infection or uncontrolled illness, except ALL or AML.
  5. Subjects with evidence of chronic hepatitis B (HBV) infection.
  6. Subjects with evidence or history of hepatitis C (HCV) infection.
  7. Subjects with a prior or concurrent malignancy (basal cell carcinoma and squamous cell skin cancer are allowed).
  8. 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.
  9. Subjects with a known hypersensitivity to pyronaridine tetraphosphate or compounds of similar chemical composition, or microcrystalline cellulose (MCC) the placebo agent.
  10. Subjects who are receiving any other investigational agents or who have received any investigational medication within the past 30 days.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Standard of care treatment plus pyronaridine

    Standard of care treatment plus pyronaridine

    Drug: Pyronaridine Tetraphosphate

  • Placebo comparator
    Standard of care treatment plus placebo

    Standard of care treatment plus placebo

    Drug: Pyronaridine Tetraphosphate

Interventions

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Dalal Jamm Hospital
    Guediawaye GOL SUD, Dakar B P 19 001, Senegal
08

References and documents

09

Updates

1 registry update since Sep 25, 2026
Status
Status unknown→Suspended Change of protocol
changed Oct 19, 2026
Start date
Nov 21, 2022→Feb 21, 2028
Oct 19, 2026
Primary completion
Feb 2024→Feb 2030
Oct 19, 2026
Study completion
Mar 2024→Mar 2030
Oct 19, 2026
Also revised
sponsor
Show all 1 update
  1. Oct 19, 2026
    Status unknown→Suspended
    Why stopped Change of protocol
    Start date Nov 21, 2022→Feb 21, 2028
    Primary completion Feb 2024→Feb 2030
    Study completion Mar 2024→Mar 2030
    Sponsor Collaborators changed
    + 4 other changes: identifiers, verification date, contact details and site details

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 ↗

10

Registry details

Key details

Study ID
NCT05291390
Lead sponsor
Armaceutica, Inc.
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
First posted
Mar 22, 2022
Start date
Feb 21, 2028 (estimated)
Primary completion
Feb 2030 (estimated)
Completion
Mar 2030 (estimated)
Last update
Oct 19, 2026

Study contacts

Renato J Aguilera, PhD
study chair · Armaceutica, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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