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Study of STI571 in the Treatment of Patients With Idiopathic Hypereosinophilic Syndrome (HES) and Eosinophilic Leukemias

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University of Bologna.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novartis
Information provided by:
University of Bologna
ClinicalTrials.gov Identifier:
NCT00276926
First received: January 12, 2006
Last updated: September 14, 2009
Last verified: September 2009
History of Changes
  Purpose

The purpose of this study is to assess the clinical anti-proliferative activity of STI571 (Glivec®, Novartis, Pharma) in patients with HES defined as:

  1. 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.
  2. 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.
  3. 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.

  4. 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

Condition Intervention Phase
Hypereosinophilic Syndrome
Chronic Eosinophilic Leukemia (CEL)
Myeloproliferative Disorders
 Drug: STI571
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Open Label Pilot Phase II Study of STI571 in the Treatment of Patients With Idiopathic Hypereosinophilic Syndrome (HES) and Eosinophilic Leukemias

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • Rate of complete response (CR) in all patients at 3rd month

Secondary Outcome Measures:
  • Duration of response (CR)
  • Overall survival at 12th month
Study Start Date: March 2003
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276926

Contacts
Contact: Giovanni Martinelli, MD +39 051 6363829 gmartino@alma.unibo.it
Contact: Livia Galletti, PhD +39 051 6363829 acute@med.unibo.it

Locations
Italy
Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna Recruiting
Bologna, Italy, 40138
Principal Investigator: Giovanni Martinelli, MD         
Sub-Investigator: Michela Rondoni, MD         
Sub-Investigator: Pier Paolo Piccaluga, MD, PhD         
Sub-Investigator: Stefania Paolini, MD         
Dipartimento di Medicina Interna - Università di Genova Recruiting
Genova, Italy, 16100
Contact: Marco Gobbi, MD    +39 010 3532395    gobbi@unige.it   
Principal Investigator: Marco Gobbi, MD         
Dipartimento di Biochimica e Biotecnologie Mediche - Università degli Studi di Napoli "Federico II" Recruiting
Napoli, Italy, 80131
Contact: Fabrizio Pane, MD    + 39 081 7463135    fabpane@unina.it   
Principal Investigator: Fabrizio Pane, MD         
Divisione di Ematologia - Università degli Studi di Napoli "Federico II" Recruiting
Napoli, Italy, 80131
Contact: Lucio Catalano, MD    + 39 081 7462068    lcatalan@unina.it   
Principal Investigator: Bruno Rotoli, MD         
Sub-Investigator: Lucio Catalano, MD         
S.C. Medicina Interna II ed Ematologia - Laboratorio di Medicina Interna e Molecolare - A.O. San Luigi Recruiting
Orbassano, Italy, 10043
Contact: Emanuela Messa, MD    +39 0119026721    emanuelamessa@yahoo.it   
Contact: Daniela Cilloni, MD    +39 0119026610    daniela.cilloni@unito.it   
Principal Investigator: Giuseppe Saglio, MD         
Sub-Investigator: Emanuela Messa, MD         
Sub-Investigator: Daniela Cilloni, MD         
Divisione di Ematologia - IRCCS Policlinico S. Matteo Recruiting
Pavia, Italy, 27100
Contact: Serena Merante, MD    +39 0382502250    s.merante@smatteo.pv.it   
Principal Investigator: Mario Lazzarino, MD         
Sub-Investigator: Serena Merante, MD         
U.O. Ematologia - Dipartimento di Oncologia ed Ematologia, Presidio Ospedaliero di Ravenna Recruiting
Ravenna, Italy, 48100
Contact: Eliana Zuffa, MD    +39 0544285752    e.zuffa@ausl.ra.it   
Principal Investigator: Alfonso Zaccaria, MD         
Sub-Investigator: Eliana Zuffa, MD         
U.O. Ematologia - Arcispedale Santa Maria Nuova Recruiting
Reggio Emilia, Italy, 42100
Contact: Paolo Avanzini, MD    +39 0522296681    paolo.avanzini@asmn.re.it   
Principal Investigator: Luigi Gugliotta, MD         
Sub-Investigator: Paolo Avanzini, MD         
Cattedra di Ematologia - Università "Tor Vergata" Recruiting
Roma, Italy, 00133
Contact: Francesco Buccisano, MD    +39 06 20902674    francesco.buccisano@uniroma2.it   
Principal Investigator: Sergio Amadori, MD         
Sub-Investigator: Francesco Buccisano, MD         
Cattedra di Ematologia - Università "La Sapienza" Recruiting
Roma, Italy, 00161
Contact: Giuliana Alimena, MD    +39 06857951    alimena@bce.med.uniroma1.it   
Principal Investigator: Franco Mandelli, MD         
Sub-Investigator: Giuliana Alimena, MD         
Divisione di Ematologia - Casa Sollievo della Sofferenza Recruiting
San Giovanni Rotondo, Italy, 71013
Contact: Pellegrino Musto, MD    +39 0882410539    p.musto@tin.it   
Principal Investigator: Angelo Michele Carella, MD         
Sub-Investigator: Pellegrino Musto, MD         
U.O.C. Ematologia e Trapianti - Policlinico "Le Scotte" Recruiting
Siena, Italy, 53100
Contact: Monica Bocchia, MD    +39 0577586798    bocchia@unisi.it   
Principal Investigator: Francesco Lauria, MD         
Sub-Investigator: Monica Bocchia, MD         
U.O. Medicina II Divisione - Ospedale Santa Chiara Recruiting
Trento, Italy, 38100
Contact: Paolo Vivaldi, MD    +39 0461903307    paolo.vivaldi@tn.it   
Principal Investigator: Mauro Pedrazzoli, MD         
Sub-Investigator: Paolo Vivaldi, MD         
Sub-Investigator: Silvia Cerù, MD         
Sub-Investigator: Anna Guella, MD         
Clinica Ematologica - Policlinico Universitario Recruiting
Udine, Italy, 33100
Contact: Mario Tiribelli, MD    +39 0432559662    mtiribelli@hotmail.com   
Principal Investigator: Renato Fanin, MD         
Sub-Investigator: Mario Tiribelli, MD         
Sponsors and Collaborators
University of Bologna
Novartis
Investigators
Principal Investigator: Michele Baccarani, MD Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00276926     History of Changes
Other Study ID Numbers: HES0203
Study First Received: January 12, 2006
Last Updated: September 14, 2009
Health Authority: Italy: The Italian Medicines Agency
Italy: Ethics Committee

Keywords provided by University of Bologna:
Hypereosinophilic Syndrome
Eosinophilic leukemias
STI571 (Gleevec)
PDGF receptor alpha
 Familiar hypereosinophilia
Myeloproliferative disorder (MPD) with eosinophilia
myeloproliferative disorders/myelodysplastic syndromes

Additional relevant MeSH terms:
Hypereosinophilic Syndrome
Myeloproliferative Disorders
Bone Marrow Diseases
 Eosinophilia
Hematologic Diseases
Leukocyte Disorders

ClinicalTrials.gov processed this record on March 03, 2015