Ph3 trial of Glivec in CML-CP patients previously untreated with IFN-alfa

Phase 1

Conditions: CML-CP patients
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2017-001804-31-Outside-EU/EEA

Lead Sponsor: ovartis Pharma K.K

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 107

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

Patients who are pregnant or possibly pregnant, significant hepatic diseases, CML patients in advanced phase

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)