Adult Clinical Trials
Why did your doctor choose SPRYCEL® (dasatinib)?
Your doctor has chosen SPRYCEL because he or she believes it is the right treatment for you.
SPRYCEL is approved for use in newly diagnosed adult patients with Ph+ CML in chronic phase based on a head-to-head clinical trial of SPRYCEL compared to imatinib.
How many patients have been treated with SPRYCEL?
Since its introduction in 2006, over 45,000 patients have been treated with SPRYCEL.*
How was SPRYCEL studied?
SPRYCEL was studied in people who were newly diagnosed with Ph+ CML in chronic phase—in direct comparison with another TKI called imatinib.
*Across all indications. SPRYCEL received initial approval in June 2006 for treatment of adults with chronic phase, accelerated phase, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior therapy, including imatinib; the effectiveness of SPRYCEL was based on treatment response that was seen in both the blood and bone marrow. SPRYCEL also received approval at that time for adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy.
The main goal of the trial was to see the effect of SPRYCEL and imatinib on cCCyR by one year.
Another goal of the study was to measure MMR.
Confirmed Complete Cytogenetic Response (cCCyR)
A cytogenetic response can occur in the bone marrow, as well as in the blood. A confirmed Complete Cytogenetic Response means that there were no signs of bad cells in 2 bone marrow tests.
Major Molecular Response (MMR)
This is a very sensitive test that can detect other bad cells in the bone marrow. A Major Molecular Response means that the amount of BCR-ABL protein is very low.
What were the results at Year 1?
More people who took SPRYCEL achieved both a confirmed CCyR and MMR than people who took imatinib.
What happened at Year 5?
Results showed that more people who took SPRYCEL were able to achieve a confirmed CCyR and MMR at the end of the 5-year study.
Did SPRYCEL help patients achieve cCCyR earlier than 1 year?
The main goal of the study was to achieve cCCyR by 1 year.
Patients were followed up with after 5 years. For those patients who achieved a cCCyR, the median time to cCCyR was 3.1 months for those who took SPRYCEL, and 5.8 months for those who took imatinib.
What are the side effects?
Medications like SPRYCEL can cause side effects, or undesired effects that people may experience. For instance, people may experience diarrhea, cramping, or fatigue—it can vary from person to person. Be sure to tell your doctor if you think you’re having a side effect with SPRYCEL.
Try to talk to your doctor soon, even if the side effect is minor. Your doctor may be able to help.
Side effects reported in at least 10% of newly-diagnosed adult patients taking SPRYCEL or imatinib
*A side effect of special interest that was reported in less than 10% of patients.
Be sure to tell your doctor if you think you're having a side effect with SPRYCEL. Your doctor will perform routing blood tests to see how you are doing while on SPRYCEL. This is a chart of serious abnormal test results from this trial of adult patients.
Serious abnormal test results
Talk to your doctor if you have any side effects. Don't wait until your symptoms get worse.
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