Status:
COMPLETED
Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Leukemia
Eligibility:
All Genders
15-60 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of acute lymphoblastic leukemia (ALL) meeting the following criteria:
- Negative myeloperoxidase stain
- Phenotype T (T-ALL) or B (B-ALL)
- No mature B-ALL (FAB L3, serum immunoglobulin-positive, terminal deoxynucleotidyl transferase-negative)
- PATIENT CHARACTERISTICS:
- Creatinine ≤ 2.5 mg/dL (after adequate hydration)
- SGOT and SGPT ≤ 3 times upper limit of normal
- LVEF ≥ 50%
- No severe psychiatric disorders
- No other concurrent malignant disease
- No presence of documented infections not responding to antibiotic and/or antifungal therapy
- Not pregnant
- PRIOR CONCURRENT THERAPY:
- No prior steroids
- No prior antiblastic chemotherapy
- No other concurrent chemotherapy or radiotherapy
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT00458848
Start Date
October 1 2004
End Date
March 1 2014
Last Update
February 15 2019
Active Locations (66)
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1
Ospedale Civile Alessandria
Alessandria, Italy, I-15100
2
Ospedale Torrette University Ancona
Ancona, Italy, 60020
3
Ospedale S. Donato
Arezzo, Italy, 52100
4
Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
Ascoli Piceno, Italy