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.: PACTR202309818279236 Date of Approval: 01/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Doxorubicin versus Idarubicin in Acute Myeloid Leukemia
Official scientific title Doxorubicin versus Idarubicin in Acute Myeloid Leukemia
Brief summary describing the background and objectives of the trial Acute Myeloid Leukemia (AML) is the most common form of acute leukemia among adults. Treatment of acute leukemia has been divided into induction chemotherapy and post-remission therapy. The goal of induction chemotherapy, that consists of anthracycline and cytarabine, is to achieve morphologic complete remission (CR), but the main problem is it has a high economic burden. Idarubicin is the anthracycline of choice that used in AML, while doxorubicin, the older anthracycline, is used in other types of cancer but not AML. Objective To evaluate the use of doxorubicin versus idarubicin in the induction phase for the treatment of AML. From an economic standpoint, to analyze the impact of the adoption of this anthracycline in Egypt’s public health system.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Haematological Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 24/09/2017
Actual trial start date 24/09/2017
Anticipated date of last follow up 30/01/2020
Actual Last follow-up date 30/01/2020
Anticipated target sample size (number of participants) 244
Actual target sample size (number of participants)
Recruitment status Completed
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Doxorubicin 45 mg/m2 3 days AML patients were randomized either to receive Dox or Ida as part of their induction therapy. The induction chemotherapy regimen was one cycle of cytarabine 100 mg/m2 as continuous infusion over 24 hours for 7 days + an anthracycline (either Dox 45 mg/m2 or Ida 12 mg/m2) bolus infusion once daily for three days. In the experimental group, Doxorubicin 45 mg/m2 was used. 120
Control Group Idarubicin 12 mg/m2 3 days AML patients were randomized either to receive Dox or Ida as part of their induction therapy. The induction chemotherapy regimen was one cycle of cytarabine 100 mg/m2 as continuous infusion over 24 hours for 7 days + an anthracycline (either Dox 45 mg/m2 or Ida 12 mg/m2) bolus infusion once daily for three days. In the control group, Idarubicin were used. 124 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
18 years or older Confirmed AML diagnosis Patients with current active second malignancy AML M3 (Promyelocytic leukemia) Patients with heart problems (low ejection fraction) Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 25/09/2017 Faculty of Pharmacy
Ethics Committee Address
Street address City Postal code Country
Qasr Al Aini Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Response to treatment Day 14 and day 28
Primary Outcome Safety of treatment the whole admition period of the patient
Secondary Outcome Pharmacoeconomic analysis At the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Cancer Institute Fom El-Khaleeg Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
None Non Non Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Cancer Institute Fom El Khaleeg Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amany El Zeiny amany.elzeiny@nci.cu.edu.eg 01005357779 El Manial
City Postal code Country Position/Affiliation
Cairo Egypt National Cancer Institute
Role Name Email Phone Street address
Public Enquiries Maggie Abbassie maggie.abbassi@pharma.cu.edu.eg 01001589925 Qasr El Aini
City Postal code Country Position/Affiliation
Cairo Egypt Faculty of Pharmacy
Role Name Email Phone Street address
Scientific Enquiries Raafat Abdel Fattah rfatah@gmail.com 01001720787 El Tagamoa
City Postal code Country Position/Affiliation
Cairo Egypt National Cancer Institute
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, would be available from principle investigator upon request, any time after study publication. Study Protocol, Statistical analysis plan and the informed consent form, would be available. Informed Consent Form,Statistical Analysis Plan,Study Protocol Open Only reviewers could ask for the IPD with explanation of the request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 21/08/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 29/08/2023 Result - 29/08/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information