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Pyronaridine in Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML)

NCT05291390 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-11-29

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

Pyronaridine Tetraphosphate

Via oral capsules.

Sponsors & Collaborators

  • Uganda Cancer Institute

    collaborator OTHER

  • African Center for Cancer Research and End of Life Care (ACREOL), Rwanda

    collaborator UNKNOWN

  • Ifakara Health Research and Development Centre

    collaborator OTHER

  • Dalal Jamm Hospital, Dakar, Senegal

    collaborator OTHER

  • Armaceutica, Inc.

    lead INDUSTRY

Principal Investigators

  • Renato J Aguilera, PhD · Armaceutica, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-21
Primary Completion
2024-02-29
Completion
2024-03-31

Countries

  • Senegal

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05291390 on ClinicalTrials.gov