Low Dose Dasatinib as First-Line Treatment [Middle East]
Type of study
First line trials
No longer recruiting
LPI-JOR-LEB-KSA-TUN-2017-01 = Low Dose Dasatinib (50 mg Daily) as First-line Treatment for Newly Diagnosed Chronic‐Phase Chronic Myeloid Leukemia
Randomized, Open-Label, Phase II, Multicenter, Multi-Country Study to Evaluate Safety and Efficacy of Dasatinib 50 mg in First-Line Treatment of Early Chronic Phase Chronic Myeloid Leukemia (ClinicalTrials.gov no NCT03625388)
What is the purpose of the study
The aim of this study is to compare the efficacy and safety of dasatinib 50 mg once daily and dasatinib 50 mg once daily in patients with early chronic phase (CP) chronic myeloid leukemia (CML).
Key inclusion criteria
This study includes patients aged 18 years and above who were diagnosed with Philadelphia chromosome-positive (Ph+) or BCR-ABL positive chronic myeloid leukemia (CML) in chronic phase (CP) within the past 12 months. Except for hydroxyurea and/or 1-2 doses of cytarabine (up to 6 g/m2 total), patients must have received no or minimal prior therapy, defined as 30 days of prior approved tyrosine kinase inhibitor (TKI). To be included patients must also have a score of 0-2 on the ECOG performance scale assessing the quality of life of cancer patients. End organ function must be adequate.
Patients with clonal evolution and no other criteria for accelerated phase (AP) will be eligible for this study.
Other criteria may apply.
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Hikma Pharmaceuticals LLC
Scientific lead / contact
Study centers / principal investigators
King Hussein Cancer Center (KHCC)
Jordan University Hospital (JUH)
American University of Beirut Medical Center (AUBMC)
The King Faisal Specialist Hospital and Research Centre (KFSH&RC)
Aziza Othmana Hospital