Open Label Pilot Phase II Study of STI571 in the Treatment of Patients With Idiopathic Hypereosinophilic Syndrome (HES) and Eosinophilic Leukemias
1. Presence of primary or secondary HES
2. Not a candidate for allogeneic bone marrow transplantation.
3. ECOG performance score of 0, 1, 2 or 3 (Karnofsky performance score > 40%).
4. Life expectancy > 4 weeks.
5. Adequate hepatic and renal function, as defined by serum transaminases < 2.5x upper
limits of normal (ULN), bilirubin < 1.5x ULN, and creatinine < 1.5x ULN.
6. Age 18 years or greater.
7. Post-menopausal, surgically sterile, or taking effective contraception in female
8. Documentation of written informed consent to participate in the trial.
9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory
tests, and other study procedures.
The presence of any of the following will exclude a subject from study enrollment:
1. Patients with clear evidence of secondary hypereosinophilia.
2. Acute myeloblastic leukemia with inv(16) positive blast or
3. CBFb-MYH11 transcripts positive leukemia
4. Lack of recovery from the acute toxic effects of previous chemotherapy [to common
toxicity criteria (CTC) grade > 1] with the exception of chemotherapy-induced
5. Treatment with any investigational agent within 4 weeks prior to study therapy.
6. Major surgeries within 4 weeks from study start or not fully recovered from any
previous surgical procedure.
7. Presence of any medical or psychiatric condition which may limit full compliance with
the study or increase the risk associated with study participation or study drug
administration, including but not limited to
8. Presence of central nervous system (CNS) illness and involvement of disease.
9. Active uncontrolled bacterial infection.
10. Known human immunodeficiency virus (HIV) infection.
11. Grade 3 or 4 bleeding.
12. Significant cardiovascular disease (i.e., uncontrolled arrhythmias, unstable angina),
or a major thromboembolic event (myocardial infarction, stroke, transient ischemic
attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis) in the last
6 months. Due to the low cardiac toxicity profile of Glivec, it is not considered an
exclusion criterion if the presence of severe complications to the viscera, among
which cardiopathies, and in particular endomyocardial fibrosis, is due or considered
to be due to HES.
13. Increased blood eosinophil counts due to the presence of physician-diagnosed asthma.
However, due to low pulmonary toxicity profile of Glivec, it is not considered an
exclusion criterion, if HES is associated with asthma, and the presence of severe
complications damaging the lungs, are considered due to HES.
14. Pregnancy or breast-feeding.
15. Malabsorption syndromes