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

Primary Purpose

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

Status

Recruiting

Phase

Phase 2

Locations

Senegal

Study Type

Interventional

Intervention

Pyronaridine Tetraphosphate

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring cancer, leukemia, phase 2, pyronaridine, oncology, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Dalal Jamm HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Standard of care treatment plus pyronaridine

Standard of care treatment plus placebo

Arm Description

Standard of care treatment plus pyronaridine

Standard of care treatment plus placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05291390

First Posted

October 7, 2021

Last Updated

November 23, 2022

Sponsor

Armaceutica, Inc.

Collaborators

Uganda Cancer Institute, African Center for Cancer Research and End of Life Care (ACREOL), Rwanda, Ifakara Health Research and Development Centre, Dalal Jamm Hospital, Dakar, Senegal

1. Study Identification

Unique Protocol Identification Number

NCT05291390

Brief Title

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

Official Title

A Phase 2a, Multi-centre, Randomised, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Pyronaridine as an Add-on Therapy in Adults With Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 21, 2022 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Armaceutica, Inc.

Collaborators

Uganda Cancer Institute, African Center for Cancer Research and End of Life Care (ACREOL), Rwanda, Ifakara Health Research and Development Centre, Dalal Jamm Hospital, Dakar, Senegal

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

cancer, leukemia, phase 2, pyronaridine, oncology, treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

All capsules contain either pyronaridine or similar-appearing placebo.

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of care treatment plus pyronaridine

Arm Type

Active Comparator

Arm Description

Standard of care treatment plus pyronaridine

Arm Title

Standard of care treatment plus placebo

Arm Type

Placebo Comparator

Arm Description

Standard of care treatment plus placebo

Intervention Type

Drug

Intervention Name(s)

Pyronaridine Tetraphosphate

Other Intervention Name(s)

Placebo

Intervention Description

Via oral capsules.

Primary Outcome Measure Information:

Title

Change in survival lengths to 1 year

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ernest T Armstrong, MBA

Phone

1(949)677-6001

ernest@armaceutica.com

First Name & Middle Initial & Last Name or Official Title & Degree

Catherine Posey-Sariñana, CCRC

Phone

1(915) 544-2557

catposey@westernskymed.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Renato J Aguilera, PhD

Organizational Affiliation

Armaceutica, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Dalal Jamm Hospital

City

Guediawaye GOL SUD

State/Province

Dakar

ZIP/Postal Code

B P 19 001

Country

Senegal

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fatou Ndiaye, MD

kinepierre1@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Links:

URL

https://pubmed.ncbi.nlm.nih.gov/30825052/

Description

The Antimalarial Drug Pyronaridine Inhibits Topoisomerase II in Breast Cancer Cells and Hinders Tumor Progression In Vivo

URL

https://pubmed.ncbi.nlm.nih.gov/30395606/

Description

Pyronaridine exerts potent cytotoxicity on human breast and hematological cancer cells through induction of apoptosis

Learn more about this trial

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

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