Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202301678338690 Date of Approval: 30/01/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pyronaridine in Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML)
Official scientific 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
Brief summary describing the background and objectives of the trial Pyronaridine (PND) is an approved malaria drug being repurposed as an anti-cancer treatment. This is a Phase 2a clinical trial on up to n=200 male and female subjects 18 years and over who were diagnosed with acute myeloid leukaemia (AML) or acute lymphoblastic leukaemia (ALL). Subjects are randomised in a 1:1 ratio to receive standard of care treatment plus either pyronaridine or placebo. Subjects self-administer the oral study medication as a pulsed therapy: 4 consecutive days then 31 days no administration. This cycle repeats 11 times. Quality of life parameters are measured. Visits include physical examinations and blood draws for CBC and CMP. Survival of subjects is tracked in Year 2. The primary objective is the difference in survival lengths in days between the pyronaridine and placebo study arms. 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 26/01/2023
Actual trial start date 26/01/2023
Anticipated date of last follow up 30/04/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Experimental Subjects weighing between 40kg and 60kg take 2 capsules per day, 1 in the morning and 1 in the evening with water for a total dose of 480mg per day. Subjects weighing greater than 60kg and up to 90kg take 3 capsules per day, 1 in the morning and 2 in the evening with water for a total dose of 720mg per day. The target dosing is between 8 and 12mg/kg/day. For example, subjects weighing 41kg and 59kg (i.e. 2 capsules per day) receive about 11.7mg/kg/day and 8.1mg/kg/day while subjects weighing 61kg and 89kg (i.e. 3 capsules per day) receive about 11.8mg/kg/day and 8.1mg/kg/day. Pyronaridine is believed to have a long biological half-life of approximately 8 days. In order to avoid excess drug accumulation, subjects in this study are given a pulsed-dose regimen. All subjects dose for 4 consecutive days and then do not dose for 31 consecutive days. This pulsed therapy is repeated every 35 days for about 1 year, which makes 11 cycles, unless terminated early. Each capsule contains either 240mg of pyronaridine tetraphosphate or microcrystalline cellulose (MCC) the inactive placebo. Study drug is self-administered orally with water. 100
Control Group Placebo All subjects dose for 4 consecutive days and then do not dose for 31 consecutive days. This pulsed therapy is repeated every 35 days for about 1 year, which makes 11 cycles, unless terminated early. Placebo capsules plus standard of cancer care. 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 120 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/08/2022 CNERS Senegal
Ethics Committee Address
Street address City Postal code Country
1 Rue Aime Cesaire Fann Residence Dakar Dakar Senegal
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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
Secondary Outcome A secondary endpoint is the difference in the safety and tolerability of treatments between the two study arms. 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dalal Jamm Hospital Hematology Department Guediawaye Dakar Senegal
FUNDING SOURCES
Name of source Street address City Postal code Country
Private 2121 Wyoming Ave. El Paso TX 79903 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Armaceutica Inc. 2121 wyoming Ave. El Paso Texas 79903 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatou Ndiaye kinepierre1@gmail.com 221338398585 Hopital Dalal Jamm Guediawaye
City Postal code Country Position/Affiliation
dakar Senegal Professor of Hematology
Role Name Email Phone Street address
Public Enquiries Ernest Armstrong ernest@armaceutica.com 19496776001 2121 Wyoming Ave.
City Postal code Country Position/Affiliation
El Paso TX 79903 United States of America Study Director
Role Name Email Phone Street address
Scientific Enquiries Ernest Armstrong ernest@armaceutica.com 9496776001 2121 Wyoming Ave.
City Postal code Country Position/Affiliation
El Paso TX 79903 United States of America Study Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification. Informed Consent Form,Study Protocol Within 12 months of study completion Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://armaceutica.com No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information