drugset / Trial / NCT05291390
Pyronaridine in Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML)
Phase 2
Unknown
200 enrolled
Armaceutica, Inc.
African Center for Cancer Research and End of Life Care (ACREOL), Rwanda · collabDalal Jamm Hospital, Dakar, Senegal · collabIfakara Health Research and Development Centre · collabUganda Cancer Institute · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2022-11-21
- Primary completion
- 2024-02
- Completion
- 2024-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pyronaridine | Unknown | — | Oral |