CML-CP patients
Conditions
Interventions
Trade Name: Glivec
Product Name: Glivec (imatinib mesylate)
Product Code: STI571
Pharmaceutical Form: Tablet
INN or Proposed INN: IMATINIB MESILATE
CAS Number: 220127-57-1
Current Sponsor code: STI571
Sponsors
Novartis Pharma K.K
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosed as CML-CP, between 15 and 75 years of age, previously untreated with IFN-alfa, performance status is normal or capable of only limited self-care. Are the trial subjects under 18? yes Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 87 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19
Exclusion criteria
Exclusion criteria: Patients who are pregnant or possibly pregnant, significant hepatic diseases, CML patients in advanced phase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy and safety of Glivec and long term prognosis in patients receiving the drug alone and in combo with INF-alfa in patients with a poor cytogenetic response;Secondary Objective: To determine long term prognosis after switching to other treatment (e.g., IFN-alfa and allogenic bone marrow transplantation) in patients with poor response or intolerance;Primary end point(s): Overall survival and duration of Chronic Phase ;Timepoint(s) of evaluation of this end point: Year 1, year 2, year 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Hematologic response, cytogenetic response, major molecular response;Timepoint(s) of evaluation of this end point: hematologic and cytogenetic response evaluation done at Week 13 (M3), 26 (M6), 39 (M9), 52 (M12), 78 (M18), 104 (M24), 130 (M30), 156 (M36) | — |
Countries
Japan
Contacts
Public ContactClinical Trial Information Desk
Novartis pharma AG
Outcome results
None listed