The purpose of this multicenter randomized study is to compare efficacy and safety of dasatinib 50 mg once daily and dasatinib 100 mg once daily in patients with early chronic phase (CP) chronic myeloid leukemia (CML)
A multicenter, prospective, open-label, randomized Phase II study to compare efficacy by measuring rates of major molecular response (MMR) at 12 months in patients with Ph+ chronic phase (CP) chronic myeloid leukemia (CML) randomized to receive either dasatinib 50 mg QD or dasatinib 100 mg QD. Approximately 100 patients are expected to be randomized. The duration of patient participation will be 18 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Film coated tablet contains dasatinib monohydrate
King Hussein Cancer Center (KHCC)
Amman, Jordan
Jordan University Hospital (JUH)
Amman, Jordan
American University of Beirut Medical Center (AUBMC)
Beirut, Lebanon
The King Faisal Specialist Hospital and Research Centre (KFSH&RC)
Riyadh, Saudi Arabia
Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test
Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1%
Time frame: 12 months
Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib
Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges
Time frame: 18 months
Transformation free survival (TFS) in eligible patients randomized to dasatinib 50 mg or dasatinib 100 mg treatment arms
Transformation free survival was measured from the start of therapy to the date of transformation to accelerated or blastic phases while on therapy or to the date of last follow-up.
Time frame: 18 months
Event free survival (EFS)
EFS is measured from the start of treatment to the date of any of the following events : loss of CHR, loss of CCyR or MCyR, dose escalation, discontinuation of therapy for toxicity or lack of efficacy, progression to AP or BP, or death from any cause at any time
Time frame: 18 months
Blastic phase (BP) transformation
BP is defined as the presence of 30% blasts or more in the peripheral blood or bone marrow
Time frame: 18 months
Overall survival
Overall survival time is defined as the time from date of randomization until the date of death from any cause at any time or date of last follow up
Time frame: 18 months
Proportion of patients with Complete cytogenetic response (CCyR) at 12 months
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Aziza Othmana Hospital
Tunis, Tunisia
defined as 0% Ph+ metaphases, or FISH ≤2%, or BCR-ABL transcripts (IS) ≤1%
Time frame: 12 months
Proportion of patients with MR 4.5 at 18 months
(BCR-ABL transcripts ≤ 0.0032%)
Time frame: 18 months
Health-Related Quality of Life (HRQoL): EORTC QOLCML24
Mean change in Health-Related Quality of Life (HRQoL) utilizing EORTC QOLCML24 questionnaire throughout treatment visits
Time frame: 18 months
Frequency of not taking the medications as prescribed
Evaluated by identifying the frequency of not taking the medications as prescribed and the reasons. The decision on non-compliance is based on the treating physician's judgment.
Time frame: 18 months