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Open Label Pilot Phase II Study of STI571 in the Treatment of Patients With Idiopathic Hypereosinophilic Syndrome (HES) and Eosinophilic Leukemias


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hypereosinophilic Syndrome, Chronic Eosinophilic Leukemia (CEL), Myeloproliferative Disorders

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Trial Information

Open Label Pilot Phase II Study of STI571 in the Treatment of Patients With Idiopathic Hypereosinophilic Syndrome (HES) and Eosinophilic Leukemias


Inclusion Criteria:



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
patients.

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.

Exclusion Criteria:

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
alopecia.

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Rate of complete response (CR) in all patients at 3rd month

Principal Investigator

Michele Baccarani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna

Authority:

Italy: The Italian Medicines Agency

Study ID:

HES0203

NCT ID:

NCT00276926

Start Date:

March 2003

Completion Date:

Related Keywords:

  • Hypereosinophilic Syndrome
  • Chronic Eosinophilic Leukemia (CEL)
  • Myeloproliferative Disorders
  • Hypereosinophilic Syndrome
  • Eosinophilic leukemias
  • STI571 (Gleevec)
  • PDGF receptor alpha
  • Familiar hypereosinophilia
  • Myeloproliferative disorder (MPD) with eosinophilia
  • myeloproliferative disorders/myelodysplastic syndromes
  • Leukemia
  • Myeloproliferative Disorders
  • Hypereosinophilic Syndrome

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