Philadelphia positive (Ph pos), BCR-ABL positive, Chronic Myeloid Leukemia (CML) MedDRA version: 9.1 Level: LLT Classification code 10009013 Term: Chronic myeloid leukaemia
Conditions
Interventions
Trade Name: GLIVEC*24CPS 100MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: imatinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: G
Sponsors
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with a cytologic and cytogenetic confirmed diagnosis of Ph pos CML. 2. Age ≥ 18 years old 3. Early chronic phase (ECP) (within 6 months from diagnosis) 4. No prior treatment with Imatinib for more than 30 days, with a washout period of at least 7 days 5. WHO performance status 0/1 6. Normal serum level of potassium, total calcium corrected for serum albumin, magnesium and phosporus, or correctable with supplements 7. ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to leukaemia. 8. Alkaline phosphatase ≤ 2.5 x ULN unless considered due to leukemia. 9. Serum bilirubin ≤ 1.5 x ULN 10. Serum creatinine ≤ 1.5 x ULN 11. Serum amylase ≤ 1.5 x ULN and serum lipase ≤ 1.5 x ULN. 12. Written informed consent prior to any study procedures being performed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Impaired cardiac function, including LVEF 450 msec on screening ECG (using the QTcF formula) . 4. History of acute (within one year) or chronic pancreatitis. 5. Impairment of gastrointestinal (GI) function, or a GI disease that may significantly alter the absorption of study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) 6. Use of therapeutic coumarin derivates (i.e. warfarin, acenocoumarol, phenprocoumon). 7. Acute or chronic liver or renal disease considered unrelated to leukaemia 8. Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol 9. Patients who are currently receiving treatment with any of the medications listed in Appendix G and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in Appendix G have the potential to prolong QT. 10. Patients who have received Imatinib for more than 30 days, or have been submitted to HSCT. 11. Patients who have received any investigational drug ≤ 4 weeks. 12. Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy. 13. Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of nilotinib). Post menopausal women must be amenorrhoic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study dr 14. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory). 15. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention. 16. Patients unwilling or unable to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the complete cytogenetic response rate at 12 months;Secondary Objective: To assess the complete cytogenetic response rate at 6, and 24 months. To assess the major and complete molecular response rate at 6, 12, and 24 months. To assess the frequency and the types of BCR-ABL kinase domain mutations at 24 months during study core and for the subsequent 3 years. To assess the rate of failures and the time to failure, at 12, 24 and 60 months To assess compliance, toxicity, and adverse events (AE) To understand the relationship between response, gene expression profile, biomarkers, and drugs plasma concentration.;Primary end point(s): The primary efficacy variable is the complete cytogenetic response (CCgR ) rate at 12 months. | — |
Countries
Italy
Outcome results
None listed