Newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP) MedDRA version: M15 Classification code 10009013
Conditions
Interventions
Product Name: Glivec 100 mg film-coated tablets
Product Code: STI571
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: imatinibi mesilas
CAS Number: 220127-57-1
Current Sponsor code: STI571
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ability to provide written informed consent prior to participation to the study. 2. Male or female patients = 18 and = 75 years of age 3. Patients within 6 months of diagnosis (date of initial diagnosis is the date of first cytogenetic analysis) 4. Diagnosis of chronic myelogenous leukemia in chronic phase with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations and presence of Bcr-Abl 5. Documented chronic phase CML as defined by: • =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients in late chronic phase, accelerated phase, or blastic phase are excluded 2. Patients who have received other investigational agents 3. Patients who received Gleevec/Glivec for any duration prior to study entry, with the exception of those patients successfully completing [CSTIA2107] study immediately prior to the participation in this study 4. Patient received any treatment for CML prior to study entry for longer than 1 month with the exception of hydroxyurea and/or anagrelide 5. Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention 6. Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to baseline and (d) male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential). 7. Patient with a severe or uncontrolled medical condition (i.e., uncontrolled diabetes, chronic renal disease) 8. Patient previously received radiotherapy to = 25% of the bone marrow 9. Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery 10. Patients with an ECOG Performance Status Score = 3 11. Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x IULN, with the exception of patients on treatment with oral anticoagulants 12. Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required 13. Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent 14. Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish whether 800 mg Gleevec/Glivec (as 400 mg bid) improves efficacy in newly diagnosed, previously untreated CML-CP patients as compared to 400 mg by the evaluation of the rate of molecular response defined as Bcr-Abl ratio =0.1% (= 3 log reductionof Bcr-Abl transcropts from a standardized baseline) as detected by RT-PCR at 12 months.;Secondary Objective: (for full list see protocol) •To determine the rate of complete hematologic response •To determine the rate of complete cytogenetic response (CCyR) •To evaluate the time to (CCyR), molecular response, and complete molecular response •To compare the percentage of patients witha major molecular response and with undetectable levels of Bcr-Abl transcripts at 12 months and yearly thereafter •To compare progression-free survival (PFS) in the two treatment arms • To compare event-free survival (EFS) in the two treatment arms To evaluate the safety profile of Gleevec/Glivec when given at 800 mg daily administered as 400 mg bid •To evaluate the actual dose-intensity delivered amongst the two treatment arms •To validate molecular response (MR) as a prognostic factor for PFS •To evaluate quality of life (QoL) and healthcare resource utilization •To determine the pharmacokinetic characteristics following 400 mg versus 800 mg •To investigate tumor-specific mutations ;Primary end point(s): Evaluation of the rate of molecular response (MR) at 12 months as measured by log reduction of Bcr-Abl transcript as detected by RT-PCR | — |
Countries
Czech Republic, Italy, Slovakia, Spain
Outcome results
None listed