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Hypereosinophilic SyndromePhase 2NCT00276926

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

A Phase 2 study testing STI571 in people with Hypereosinophilic Syndrome and Chronic Eosinophilic Leukemia (CEL), run by University of Bologna at 14 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
STI571
How many people
Not given
Where
14 sitesItaly
Study dates
Mar 2003to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

14 sites in 1 country.

Giovanni Martinelli, MD contact

+39 051 6363829

gmartino@alma.unibo.it

Livia Galletti, PhD contact

+39 051 6363829

acute@med.unibo.it

14 sites in 1 country

Italy14 sites, 14 recruiting

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

    Bologna, 40138

    Giovanni Martinelli, MD

    Michela Rondoni, MD

    Recruiting

  • Dipartimento di Medicina Interna - Università di Genova

    Genova, 16100

    Marco Gobbi, MD, +39 010 3532395, gobbi@unige.it

    Marco Gobbi, MD

    Recruiting

  • Dipartimento di Biochimica e Biotecnologie Mediche - Università degli Studi di Napoli "Federico II"

    Naples, 80131

    Fabrizio Pane, MD, + 39 081 7463135, fabpane@unina.it

    Fabrizio Pane, MD

    Recruiting

  • Divisione di Ematologia - Università degli Studi di Napoli "Federico II"

    Naples, 80131

    Lucio Catalano, MD, + 39 081 7462068, lcatalan@unina.it

    Bruno Rotoli, MD

    Recruiting

  • S.C. Medicina Interna II ed Ematologia - Laboratorio di Medicina Interna e Molecolare - A.O. San Luigi

    Orbassano, 10043

    Emanuela Messa, MD, +39 0119026721, emanuelamessa@yahoo.it

    Daniela Cilloni, MD, +39 0119026610, daniela.cilloni@unito.it

    Recruiting

  • Divisione di Ematologia - IRCCS Policlinico S. Matteo

    Pavia, 27100

    Serena Merante, MD, +39 0382502250, s.merante@smatteo.pv.it

    Mario Lazzarino, MD

    Recruiting

  • U.O. Ematologia - Dipartimento di Oncologia ed Ematologia, Presidio Ospedaliero di Ravenna

    Ravenna, 48100

    Eliana Zuffa, MD, +39 0544285752, e.zuffa@ausl.ra.it

    Alfonso Zaccaria, MD

    Recruiting

  • U.O. Ematologia - Arcispedale Santa Maria Nuova

    Reggio Emilia, 42100

    Paolo Avanzini, MD, +39 0522296681, paolo.avanzini@asmn.re.it

    Luigi Gugliotta, MD

    Recruiting

  • Cattedra di Ematologia - Università "Tor Vergata"

    Roma, 00133

    Francesco Buccisano, MD, +39 06 20902674, francesco.buccisano@uniroma2.it

    Sergio Amadori, MD

    Recruiting

  • Cattedra di Ematologia - Università "La Sapienza"

    Roma, 00161

    Giuliana Alimena, MD, +39 06857951, alimena@bce.med.uniroma1.it

    Franco Mandelli, MD

    Recruiting

  • Divisione di Ematologia - Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

    Pellegrino Musto, MD, +39 0882410539, p.musto@tin.it

    Angelo Michele Carella, MD

    Recruiting

  • U.O.C. Ematologia e Trapianti - Policlinico "Le Scotte"

    Siena, 53100

    Monica Bocchia, MD, +39 0577586798, bocchia@unisi.it

    Francesco Lauria, MD

    Recruiting

  • U.O. Medicina II Divisione - Ospedale Santa Chiara

    Trento, 38100

    Paolo Vivaldi, MD, +39 0461903307, paolo.vivaldi@tn.it

    Mauro Pedrazzoli, MD

    Recruiting

  • Clinica Ematologica - Policlinico Universitario

    Udine, 33100

    Mario Tiribelli, MD, +39 0432559662, mtiribelli@hotmail.com

    Renato Fanin, MD

    Recruiting

Other trials in Italy

About this study

Official title: 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:

  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
Being tested
STI571
Keywords
Hypereosinophilic Syndrome, Eosinophilic leukemias, STI571 (Gleevec), PDGF receptor alpha, Familiar hypereosinophilia, Myeloproliferative disorder (MPD) with eosinophilia, myeloproliferative disorders/myelodysplastic syndromes
Medical subject headings
Hypereosinophilic Syndrome, Pdgfra-Associated Chronic Eosinophilic Leukemia, Myeloproliferative Disorders, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STI571Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

  1. Duration of response (CR)

  2. Overall survival at 12th month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2006 (estimated)
  2. Study startMar 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00276926
Sponsor's protocol ID
HES0203
Status last verified
Sep 2009
First submitted
12 Jan 2006
Last updated
15 Sep 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing STI571 in people with Hypereosinophilic Syndrome and Chronic Eosinophilic Leukemia (CEL), run by University of Bologna at 14 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Giovanni Martinelli, MD (+39 051 6363829, gmartino@alma.unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of complete response (CR) in all patients at 3rd month. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00276926.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009.

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