Status:
COMPLETED
STI 571 (GLIVEC) in the Treatment of Adult Acute Lymphoblastic Leukemia
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This proposal, developed in the framework of the GIMEMA, will permit: * to evaluate the activity and toxicity of imatinib in the treatment of Ph+ acute lymphoblastic leukemia; * to evaluate the molec...
Detailed Description
Imatinib shows a specific activity for the ABL protein- tyrosine kinase at the in vitro and in vivo level. The compound exerts a direct inhibition on the proliferation of BCR/ABL+ve cells, in cell lin...
Eligibility Criteria
Inclusion
- Patients with Ph +ve and/or BCR/ABL +ve ALL, either in 1st CHR (independently from the molecular status) for study A, or at diagnosis and untreated for study B;
- Age \>18 years and \<60 for study A, \>60 for study B;
- Written voluntary informed consent.
Exclusion
- Patients of childbearing potential without a negative pregnancy test prior to the initiation of study. Barrier contraceptive precautions are to be used throughout the trial in both sexes;
- Pretreatment with steroids for more than 10 days in study B;
- Serum bilirubin and creatinine values \>3 the upper limit of normal range;
- SGOT and SGPT values \>3 the upper limit of the normal range;
- Patients who had received any other investigational agent within 4 weeks before the enrollment;
- Patients with cardiovascular diseases grade \>3 according to the New York Heart Association (see Appendix 1);
- Patients with a history of non compliance to medical regimen or who are considered potentially unreliable;
- Patients with moderate/severe mood or psychiatric disorders;
- Concomitant neoplasia.
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00376467
Start Date
December 1 2001
End Date
February 1 2011
Last Update
February 7 2014
Active Locations (28)
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1
Divisione di Ematologia, Azienda Policlinico "Umberto I", Università degli Studi "La Sapienza"
Rome, Rome, Italy, 00161
2
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona, Italy
3
Az.Ospedaliera S.G.Moscati
Avellino, Italy
4
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna, Italy