Low Dose Dasatinib as First-Line Treatment [Middle East]

Study title

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

Scientific title

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)

Indication and most important inclusion criteriaRandomized, 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 n

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.

Short description of intervention

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).

Type of study

First line trials

Current status

Recruiting

Study sponsor

Hikma Pharmaceuticals LLC

Scientific lead / contact

Hikma Pharmaceuticals
medical-information@hikma.com

Principal investigator

Multiple

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

Jordan

King Hussein Cancer Center (KHCC)
Amman, 11941

Jordan University Hospital (JUH)
Amman, 11942

Lebanon

American University of Beirut Medical Center (AUBMC)
Beirut

Saudi Arabia

The King Faisal Specialist Hospital and Research Centre (KFSH&RC)
Riyadh

Tunisia

Aziza Othmana Hospital
Tunis, 1006