Ph+ CML in early chronic phase MedDRA version: 14.1 Level: PT Classification code 10009013 Term: Chronic myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: TASIGNA*112CPS 150MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: nilotinib
Current Sponsor code: AMN107
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
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+ CML. 2. Age = 18 years old 3. Early CP (within 6 months from diagnosis) 4. No prior treatment with any antileukemic drugs with the exception of Hydroxyurea (HU) and Anagrelide. 5. WHO performance status of = 2 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: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: 1. Impaired cardiac function, including LVEF 450 msec on screening ECG (using the QTcF formula) . Patients with ventricular pacemakers and clinically significant bradycardias. Patients with heart blocks. 4. History of acute or chronic pancreatitis. 5. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of nilotinib (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 E and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in Appendix E have the potential to prolong QT, with the exception of HU and Anagrelide. 10. Patients who have received any antileukemic agents and treatments, including HSCT, with the exception of HU and Anagrelide. 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 drug. 14. Treatment with any hematopoietic colony-stimulating growth factors (e.g. G-CSF, GM-CSF) ?1 week prior to starting study drug. 15. Patients who have received immunotherapy ?1 week prior to starting study drug or who have not recovered from side effects of such therapy. 16. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory). 17. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention. 18. Patients unwilling or unable to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the cytogenetic and molecular effects of the protein tyrosine kinase (PTK) inhibitor nilotinib in the treatment of early chronic phase Ph+ CML.;Secondary Objective: To investigate in early CP Ph+ CML patients treated with nilotinib the clinical and the hematologic effects, the effect on bcr/abl point mutations, the kinetic of the response, the toxicity, the compliance to treatment and the dose density in the medium-long term.;Primary end point(s): Primary efficacy variable is Complete cytogenetic response (CCgR ) rate at 1 year.;Timepoint(s) of evaluation of this end point: After 1 year from the last enrolled patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess in early CP Ph pos patients treated with nilotinib the clinical, hematologic and molecular responses, the kinetic of the response, the toxicity and the compliance to treatment in the medium-long term..;Timepoint(s) of evaluation of this end point: At the end of the study. | — |
Countries
Italy
Contacts
Public ContactCentro Dati
G.I.M. EM. A.
Outcome results
None listed