- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00276926
Study of STI571 in the Treatment of Patients With Idiopathic Hypereosinophilic Syndrome (HES) and Eosinophilic Leukemias
Open Label Pilot Phase II Study of STI571 in the Treatment of Patients With Idiopathic Hypereosinophilic Syndrome (HES) and Eosinophilic Leukemias
The purpose of this study is to assess the clinical anti-proliferative activity of STI571 (Glivec®, Novartis, Pharma) in patients with HES defined as:
- Idiopathic Hypereosinophilic Syndrome (secondary HES), defined as a peripheral blood eosinophilia greater than 1,500 cells/µL for longer than 6 months, absence of other apparent aetiologies for eosinophilia and with or without signs and symptoms of organ involvement, irrespective to expression of any of imatinib targets (c-Kit receptor, PDGFR, bcr-abl receptor) on bone marrow cells.
- Familiar hypereosinophilia defined as a peripheral blood eosinophilia greater than 1,500 cells/µL for longer than 6 months, absence of other apparent aetiologies for eosinophilia and signs and symptoms of organ involvement, irrespective to expression of any of imatinib targets (c-Kit receptor, PDGFR, bcr-abl receptor) on bone marrow cells, and with a recognized or reported cases of hypereosinophilia in the patient's family.
- Chronic myeloproliferative disorder, defined as chronic eosinophilic leukemia (CEL) with the presence of blasts (>10%) in the bone marrow (BM), or the presence of immature eosinophils in different tissues, or an aggressive clinical course or the presence of clonal cytogenetic anomalies.
Myeloproliferative disorder (MPD) with eosinophilia, eosinophilic leukemia or chronic myelomonocytic leukemia [myeloproliferative disorders/myelodysplastic syndromes (MPD/MDS)] with evidence of:
- t(5;12)(q33;p13) by cytogenetic or fluorescent in situ hybridization (FISH) analysis, or
- ETV6/TEL-PDGFRB fusion transcript by reverse transcription polymerase chain reaction (RT-PCR), or
- PDGFRB disruption, assessed or suspected, by other translocations with additional partner genes (H4, HIP1, CEV14 and Rab5) 5, or
- MPD/MDS who have constitutive activation of the gene for platelet-derived growth factor receptor beta (PDGFRB) 6 by point mutations
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Giovanni Martinelli, MD
- Phone Number: +39 051 6363829
- Email: gmartino@alma.unibo.it
Study Contact Backup
- Name: Livia Galletti, PhD
- Phone Number: +39 051 6363829
- Email: acute@med.unibo.it
Study Locations
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Bologna, Italy, 40138
- Recruiting
- Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna
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Sub-Investigator:
- Michela Rondoni, MD
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Sub-Investigator:
- Pier Paolo Piccaluga, MD, PhD
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Genova, Italy, 16100
- Recruiting
- Dipartimento di Medicina Interna - Università di Genova
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Contact:
- Marco Gobbi, MD
- Phone Number: +39 010 3532395
- Email: gobbi@unige.it
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Napoli, Italy, 80131
- Recruiting
- Dipartimento di Biochimica e Biotecnologie Mediche - Università degli Studi di Napoli "Federico II"
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Contact:
- Fabrizio Pane, MD
- Phone Number: + 39 081 7463135
- Email: fabpane@unina.it
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Napoli, Italy, 80131
- Recruiting
- Divisione di Ematologia - Università degli Studi di Napoli "Federico II"
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Contact:
- Lucio Catalano, MD
- Phone Number: + 39 081 7462068
- Email: lcatalan@unina.it
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Principal Investigator:
- Bruno Rotoli, MD
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Sub-Investigator:
- Lucio Catalano, MD
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Orbassano, Italy, 10043
- Recruiting
- S.C. Medicina Interna II ed Ematologia - Laboratorio di Medicina Interna e Molecolare - A.O. San Luigi
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Contact:
- Emanuela Messa, MD
- Phone Number: +39 0119026721
- Email: emanuelamessa@yahoo.it
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Contact:
- Daniela Cilloni, MD
- Phone Number: +39 0119026610
- Email: daniela.cilloni@unito.it
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Principal Investigator:
- Giuseppe Saglio, MD
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Sub-Investigator:
- Daniela Cilloni, MD
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Pavia, Italy, 27100
- Recruiting
- Divisione di Ematologia - IRCCS Policlinico S. Matteo
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Contact:
- Serena Merante, MD
- Phone Number: +39 0382502250
- Email: s.merante@smatteo.pv.it
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Principal Investigator:
- Mario Lazzarino, MD
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Sub-Investigator:
- Serena Merante, MD
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Ravenna, Italy, 48100
- Recruiting
- U.O. Ematologia - Dipartimento di Oncologia ed Ematologia, Presidio Ospedaliero di Ravenna
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Contact:
- Eliana Zuffa, MD
- Phone Number: +39 0544285752
- Email: e.zuffa@ausl.ra.it
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Sub-Investigator:
- Eliana Zuffa, MD
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Reggio Emilia, Italy, 42100
- Recruiting
- U.O. Ematologia - Arcispedale Santa Maria Nuova
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Contact:
- Paolo Avanzini, MD
- Phone Number: +39 0522296681
- Email: paolo.avanzini@asmn.re.it
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Sub-Investigator:
- Paolo Avanzini, MD
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Roma, Italy, 00133
- Recruiting
- Cattedra di Ematologia - Università "Tor Vergata"
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Contact:
- Francesco Buccisano, MD
- Phone Number: +39 06 20902674
- Email: francesco.buccisano@uniroma2.it
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Sub-Investigator:
- Francesco Buccisano, MD
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Roma, Italy, 00161
- Recruiting
- Cattedra di Ematologia - Università "La Sapienza"
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Contact:
- Giuliana Alimena, MD
- Phone Number: +39 06857951
- Email: alimena@bce.med.uniroma1.it
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Principal Investigator:
- Franco Mandelli, MD
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Sub-Investigator:
- Giuliana Alimena, MD
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San Giovanni Rotondo, Italy, 71013
- Recruiting
- Divisione di Ematologia - Casa Sollievo della Sofferenza
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Contact:
- Pellegrino Musto, MD
- Phone Number: +39 0882410539
- Email: p.musto@tin.it
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Sub-Investigator:
- Pellegrino Musto, MD
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Siena, Italy, 53100
- Recruiting
- U.O.C. Ematologia e Trapianti - Policlinico "Le Scotte"
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Contact:
- Monica Bocchia, MD
- Phone Number: +39 0577586798
- Email: bocchia@unisi.it
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Sub-Investigator:
- Monica Bocchia, MD
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Trento, Italy, 38100
- Recruiting
- U.O. Medicina II Divisione - Ospedale Santa Chiara
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Contact:
- Paolo Vivaldi, MD
- Phone Number: +39 0461903307
- Email: paolo.vivaldi@tn.it
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Principal Investigator:
- Mauro Pedrazzoli, MD
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Sub-Investigator:
- Paolo Vivaldi, MD
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Sub-Investigator:
- Silvia Cerù, MD
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Sub-Investigator:
- Anna Guella, MD
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Udine, Italy, 33100
- Recruiting
- Clinica Ematologica - Policlinico Universitario
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Contact:
- Mario Tiribelli, MD
- Phone Number: +39 0432559662
- Email: mtiribelli@hotmail.com
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Sub-Investigator:
- Mario Tiribelli, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Presence of primary or secondary HES
- Not a candidate for allogeneic bone marrow transplantation.
- ECOG performance score of 0, 1, 2 or 3 (Karnofsky performance score > 40%).
- Life expectancy > 4 weeks.
- 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.
- Age 18 years or greater.
- Post-menopausal, surgically sterile, or taking effective contraception in female patients.
- Documentation of written informed consent to participate in the trial.
- 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:
- Patients with clear evidence of secondary hypereosinophilia.
- Acute myeloblastic leukemia with inv(16) positive blast or
- CBFb-MYH11 transcripts positive leukemia
- 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.
- Treatment with any investigational agent within 4 weeks prior to study therapy.
- Major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure.
- 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
- Presence of central nervous system (CNS) illness and involvement of disease.
- Active uncontrolled bacterial infection.
- Known human immunodeficiency virus (HIV) infection.
- Grade 3 or 4 bleeding.
- 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.
- 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.
- Pregnancy or breast-feeding.
- Malabsorption syndromes
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Rate of complete response (CR) in all patients at 3rd month
|
Secondary Outcome Measures
Outcome Measure |
---|
Duration of response (CR)
|
Overall survival at 12th month
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Leukocyte Disorders
- Eosinophilia
- Syndrome
- Leukemia
- Hypereosinophilic Syndrome
- Myeloproliferative Disorders
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Imatinib Mesylate
Other Study ID Numbers
- HES0203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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