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

NCT05291390 | Unknown Phase 2 DMC

• 1 other identifier: PND7351
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

cancer; leukemia; phase 2; pyronaridine; oncology; treatment

Outcome Measures

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.

  1 year

Study Arms (2)

Standard of care treatment plus pyronaridine

ACTIVE COMPARATOR

Standard of care treatment plus pyronaridine

Drug: Pyronaridine Tetraphosphate

Standard of care treatment plus placebo

PLACEBO COMPARATOR

Standard of care treatment plus placebo

Drug: Pyronaridine Tetraphosphate

Interventions

Pyronaridine Tetraphosphate DRUG

Via oral capsules.

Also known as: Placebo

Standard of care treatment plus placebo; Standard of care treatment plus pyronaridine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Armaceutica, Inc.: lead
• Uganda Cancer Institute: collaborator
• African Center for Cancer Research and End of Life Care (ACREOL), Rwanda: collaborator
• Ifakara Health Research and Development Centre: collaborator
• Dalal Jamm Hospital, Dakar, Senegal: collaborator

Study Sites (1)

Dalal Jamm Hospital

Guediawaye GOL SUD, Dakar, B P 19 001, Senegal

RECRUITING

Related Links

• The Antimalarial Drug Pyronaridine Inhibits Topoisomerase II in Breast Cancer Cells and Hinders Tumor Progression In Vivo
• Pyronaridine exerts potent cytotoxicity on human breast and hematological cancer cells through induction of apoptosis

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasms; Leukemia

Interventions

pyronaridine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Renato J Aguilera, PhD

  Armaceutica, Inc.

  STUDY CHAIR

Central Study Contacts

Ernest T Armstrong, MBA

CONTACT

1(949)677-6001; ernest@armaceutica.com

Catherine Posey-Sariñana, CCRC

CONTACT

1(915) 544-2557; catposey@westernskymed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All capsules contain either pyronaridine or similar-appearing placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: March 22, 2022
• Study Start: November 21, 2022
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 29, 2022

Record last verified: 2022-07

Locations

SE (1)