An Open-Label, Phase I/II Study of Two Different Schedules of Dasatinib (Sprycel) and Decitabine (Dacogen) Used in Combination for Patients With Accelerated or Blastic Phase Chronic Myelogenous Leukemia (Protocol CA180357)
If you are found to be eligible to take part in this study, you will be assigned to a study
group and dose level based on when you join this study and the side effects that are seen.
Your doctor will discuss this with you in more detail.
There will be up to 5 doses of dasatinib tested in Phase 1. The first 3 participants will
receive a lower dose of therapy. If no major side effects are seen in these participants,
the next participants will receive a higher dose. Once a dose is identified that is
well-tolerated for most participants, that dose will be used for all new participants. If
you are in Phase 2, you will receive a dose level tested in Phase 1.
You will receive one of 2 doses of decitabine. What dose you receive is determined by
chance (like a coin toss).
Each cycle is 28 days.
You will take dasatinib by mouth 1 time a day.
You will receive decitabine by vein for 10 days of each cycle. If the doctor thinks it is in
your best interest, you may receive decitabine for fewer days each cycle (5 days instead of
10 days). Your doctor will decide how many doses you will take based on side effects you may
have and the status of the disease.
If you have severe side effects from the study drug, the study doctor may decide to stop
drug dosing until your side effects improve.
You will be asked to keep a study diary that will be reviewed at scheduled study visits. In
the diary, you will record when you take the study drug.
At every visit, you will be asked about any side effects you may have had and to list any
drugs you may be taking.
Every week for the first 3 cycles and then every 2-4 weeks after that, blood (about 1
tablespoon) will be drawn to check your blood cell counts.
About 1 week after your first dose, you will have an ECG.
Every 1-2 weeks for the first 3 cycles and then every 4-8 weeks after that, blood (about 1
tablespoon) will be drawn to test your kidney and liver function.
Before the start of Cycle 2, every 2-4 cycles after that for the first year, and then every
6 cycles after that, you will have a complete physical exam.
Before the start of Cycle 2, every 3 cycles after that during the first year, then every 4-6
cycles (as needed) you will have a bone marrow aspirate to check the status of the disease.
After Cycle 6, the number of blood draws and bone marrow collections may be changed.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drug if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.
This is an investigational study. Dasatinib is FDA approved and commercially available for
the treatment of patients with certain types of CML.
Decitabine is FDA approved for the treatment of patients with myelodysplastic syndrome.
The combination of these drugs to treat CML is investigational.
Up to 84 patients will take part in this study. All will be enrolled at MD Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) Dasatinib and Decitabine
Maximum tolerated dose (MTD) defined as highest dose at which 0 of 3 or = 1/6 participant experience a first cycle dose limiting toxicity (DLT).
End of first 28-day cycle
Jorge Cortes, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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