Ph positive (Ph+)/Bcr-Abl positive Acute Lymphoblastic Leukemia (ALL) MedDRA version: 9.1 Level: LLT Classification code 10000844
Conditions
Interventions
Trade Name: TASIGNA*28CPS 200MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Nilotinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name:
Sponsors
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL`ADULTO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with previously untreated Ph+ and/or BCR/ABL + ALL: o age 60 years old or o age > 18 years old, but unfit for program of intensive therapy and allogeneic SCT 2. Written informed consent prior to any study procedures being performed 3. Effective contraception 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. WHO performance status _ 50% (Karnofsky) or _ 3 (ECOG) 5. History of acute (within one year) or chronic pancreatitis. 6. Active HBV or HCV hepatitis, or AST/ALT more than 5 times ULN or bilirubine more than 5 time ULN or INR>1.5 7. Creatinine level >2.5mg/dl or VFG5g/day 8. Impairment of gastrointestinal (GI) function, or a GI disease that may significantly alter the absorption of study drugs (e.g., severe malabsorption syndrome, or extended small bowel resection) 9. Patients who are currently receiving treatment with any of the medications listed in Appendix D if the medications cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in Appendix D have the potential to prolong QT. 10. Patients who have received any investigational drug _ 4 weeks. 11. Patients who have undergone major surgery _ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy. 12. Patients who are pregnant 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 imatinib and 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 drugs. 13. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention. 14. Patients unwilling or unable to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy variable is the Disease-Free Survival (DFS) at 24 weeks (after 4 courses of treatment), defined as the time from the date of 1st CHR to loss of CHR or CCyR, whichever comes first.;Main Objective: The objective of the trial is to evaluate the therapeutic effects of NIL and IM given in turn (in rotation) in terms of Disease-Free Survival (DFS) at 24 weeks (after 4 courses of treatment).;Secondary Objective: 1. Complete Hematological Response (CHR) rate at 6, 12 and 24 weeks 2. Complete Cytogenetic Response (CCgR) rate at 6, 12 and 24 weeks, and duration of CCgR 3. Complete molecular response (CMR) rate at 12 and 24 weeks, and duration of CMolR 4. Type and number of BCR-ABL kinase domain mutations developing during and after the study 5. Relationship between response, biomarkers and gene expression profile (GEP) 6. Event-free survival (EFS) and Overall Survival (OS) 7. Side effects, adverse events (AE) and serious AE (SAE) | — |
Countries
Italy
Outcome results
None listed