This is a Phase I, single-center, open label, prospective, single-arm, dose-escalation and multi-dose study evaluating the use of ibrutinib in combination with dasatinib and prednisone therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Ibrutinib 420mg PO daily (dose level 0) or 560mg PO daily (dose level +1) administered Day 15 through day 90.
Dasatinib 100mg PO daily (Day 1 through Day 90). Dasatinib dose will be increased to 140mg daily in patients tolerating dasatinib 100mg who have not achieved a complete bone marrow response (less than 5% blasts) by Day 22 or who have not achieved major molecular response by Day 43.
Prednisone 60mg/m2 PO daily (Day 1 through Day 32)
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Incidence of adverse events of combination of ibrutinib and dasatinib
Time frame: Patient safety will be evaluated throughout the treatment period (treatment with Ibrutinib and dasatinib which is expected to last 90 days for each patient)
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