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
1 other identifier
interventional
N/A
1 country
14
Brief 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:
- 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
Trial Health
Trial Health Score
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14 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 12, 2006
CompletedFirst Posted
Study publicly available on registry
January 13, 2006
CompletedSeptember 15, 2009
September 1, 2009
January 12, 2006
September 14, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of complete response (CR) in all patients at 3rd month
Secondary Outcomes (2)
Duration of response (CR)
Overall survival at 12th month
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Pregnancy or breast-feeding.
- Malabsorption syndromes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bolognalead
- Novartiscollaborator
Study Sites (14)
Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna
Bologna, 40138, Italy
Dipartimento di Medicina Interna - Università di Genova
Genova, 16100, Italy
Dipartimento di Biochimica e Biotecnologie Mediche - Università degli Studi di Napoli "Federico II"
Napoli, 80131, Italy
Divisione di Ematologia - Università degli Studi di Napoli "Federico II"
Napoli, 80131, Italy
S.C. Medicina Interna II ed Ematologia - Laboratorio di Medicina Interna e Molecolare - A.O. San Luigi
Orbassano, 10043, Italy
Divisione di Ematologia - IRCCS Policlinico S. Matteo
Pavia, 27100, Italy
U.O. Ematologia - Dipartimento di Oncologia ed Ematologia, Presidio Ospedaliero di Ravenna
Ravenna, 48100, Italy
U.O. Ematologia - Arcispedale Santa Maria Nuova
Reggio Emilia, 42100, Italy
Cattedra di Ematologia - Università "Tor Vergata"
Roma, 00133, Italy
Cattedra di Ematologia - Università "La Sapienza"
Roma, 00161, Italy
Divisione di Ematologia - Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013, Italy
U.O.C. Ematologia e Trapianti - Policlinico "Le Scotte"
Siena, 53100, Italy
U.O. Medicina II Divisione - Ospedale Santa Chiara
Trento, 38100, Italy
Clinica Ematologica - Policlinico Universitario
Udine, 33100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michele Baccarani, MD
Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 12, 2006
First Posted
January 13, 2006
Study Start
March 1, 2003
Last Updated
September 15, 2009
Record last verified: 2009-09