Exploratory Study of IMATINIB High Dose in Intermediate Risk Chronic Myeloid Leukemia in Chronic Phase
NCT00510926 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2007-08-03
Summary
Results in CP are better in patients treated early after the onset of the disease with respect to late CP . To date, the early McR rate to imatinib is clearly higher in low and intermediate risk versus high risk (88 and 84% versus 65%). High dose of imatinib, as shown in phase I-III trials may offer the possibility to increase the response rate of patients belonging to this risk category.
Conditions
- Myeloid Leukemia, Chronic, Chronic-Phase
Interventions
- DRUG
-
Imatinib Mesilate (Glivec)
Sponsors & Collaborators
-
University of Bologna
lead OTHER
Principal Investigators
-
Michele Baccarani, MD · Policlinico S.Orsola-Malpighi - Istituto di Ematologia e Oncologia Medica "L. e A.Seràgnoli", Bologna
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-01-31
- Completion
- 2006-11-30
Countries
- Italy
Study Locations
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