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

November 23, 2022 updated by: Armaceutica, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of care treatment plus pyronaridine
Drug: Pyronaridine Tetraphosphate
Via oral capsules.
Other Names:
  • Placebo
Placebo Comparator: Standard of care treatment plus placebo
Drug: Pyronaridine Tetraphosphate
Via oral capsules.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in survival lengths to 1 year
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armaceutica, Inc.

Collaborators

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

Investigators

  • Study Chair: Renato J Aguilera, PhD, Armaceutica, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2022

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 23, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PND7351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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