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
Chronic Myeloid Leukemia
also called: Chronic Myelogeneous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
Philadelphia chromosome
A certain change in chromosomes (on chromosome 22) found in 95% of patients who have CML. The Philadelphia chromosome results from a mutation that involves the fusion of parts of chromosome 9 and chromosome 22 (the bcr-abl fusion gene)
Inclusion criteria
Inlusion criteria define which subjects may participate in a clinical study. Study subjects must fulfill all inclusion criteria (e.g. with regard to sex, age, previous diseases). This ensures a uniform composition of the study population and minimizes the risk of influences that distort the study results.
Accelerated Phase
A phase of development of Chronic Myeloid Leukemia between chronic and blast phase. Untreated, the accelerated phase progresses to blast phase within a few months.
Clonal evolution
The accumulation of DNA (chromosome) changes which leads to progression of the disease
Chronic phase
The earliest phase of CML development.
Open-label
A clinical trial in which researchers and participants know which treatment is being provided to each patient (opposite to "blinded trials" or "double-blind studies")
Chromosome
A chromosome is a structure of DNA that carries the genetic makeup in the nucleus of the cell. Chromosomes contain giant chain molecules of DNA, coiled and folded as aggregates with specific proteins. Chromosomes ensure that during cell division the hereditary information is evenly distributed to the daughter cells. Normal human body cells have 46 chromosomes. Cancer cells can have a different number and/or structure of chromosomes.
Indication
In medicine, a reason to use a certain diagnostic test, therapeutic procedure or medication. The opposite of indication is contraindication.
Dasatinib
Trade name: Sprycel, development name: BMS-354825, inhibits BCR-ABL and SRC tyrosine kinases. Authorized for marketing in the EU since 2006 for the treatment of CML and Ph+ALL.
Other names: BMS-354825|BMS354825|Sprycel
BCR-ABL
The abnormal gene that characterizes Chronic Myeloid Leukemia, which is a fusion of the BCR gene of chromosome 9 and the ABL gene of chromosome 22
Chronic
Long-lasting, slowly developping
ECOG
Eastern Cooperative Oncology Group Index to classify the quality of life of cancer patients on a scale ranging from 0 (fully active, able to carry on all predisease activities without restriction) to 5 (death).
Also often referred to as ECOG performance status.
CML
Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
Ph+
Abbreviation for "Philadelphia-Chromosome-positive", meaning the presence of a certain change in chromosomes (on chromosome 22) found in 95% of patients who have CML. The Philadelphia chromosome results from a mutation that involves the fusion of parts of chromosome 9 and chromosome 22 (the bcr-abl fusion gene).
CHR
Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
