Philadelphia chromosome positive Acute Lymphoblastic Leukemia in elderly Patients (55 years and older)
Conditions
Interventions
Trade Name: Tasigna
Product Name: Nilotinib (Tasigna (R))
Product Code: AMN107
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NILOTINIB
CAS Number: 641571-10-0
Concentration unit: mg milligra
Sponsors
Dekan des Fachbereichs Medizin der Goethe Universität, represented by the Coordinating Investigator
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients > 55 years 2. Philadelphia chromosome- or BCR-ABL positive acute lymphoblastic leukemia 3. Not previously treated except with corticosteroids or single dose vincristine (three doses cyclophosphamide accepted) 4. With or without documented CNS involvement 5. WHO performance status LLN (lower limit of normal) of potassium, magnesium, total calcium (corrected for serum albumin) or corrected to within normal limits with supplements, prior to the first dose of study medication 7. Signed written inform consent 8. Molecular evaluation for BCR-ABL performed 9. Willingness of male subjects whose sexual partners are women of child-bearing potential (WOCBP), to use an effective form of contraception (pearl index =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Patient previously treated with tyrosine kinase inhibitors 2. Known impaired cardiac function, including any of the following: • LVEF 450 msec on screening ECG. If QTc > 450 msec and electrolytes are not within normal ranges before nilotinib dosing, electrolytes should be corrected and then the patient rescreened for QTcF criterion. • Myocardial infarction with 12 months prior to starting nilotinib • Other clinical significant heart disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension) 3. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention 4. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) or known infection with Hepatitis B or C 5. Treatment with any, other investigational agent or participating in another trial within 30 days prior to entering this study 6. Inadequate hepatic functions defined as ASAT or ALAT > 2,5 times the institutional upper limit of normal or > 5 times ULN if considered due to leukemia 7. Total bilirubin > 2 fold the institutional upper limit unless considered to be due to organ involvement by the leukemia or to M. Gilbert / M. Meulengracht 8. Concurrent severe diseases which exclude the administration of therapy 9. Past history of acute or chronic pancreatitis 10. Patients unwilling or unable to comply with the protocol. .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of a nilotinib-based induction and consolidation therapy. ;Secondary Objective: To evaluate the safety of a nilotinib-based induction and consolidation therapy. ;Primary end point(s): Rate of patients without event at 12 months ;Timepoint(s) of evaluation of this end point: after 12 months of treatment. During or after 3rd year of the whole trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a. The rate of complete hematological remission after induction treatment b. The rate of major molecular response defined by a BCR-ABL/ABL ratio < 0.1% in bone marrow c. The rate of complete molecular response defined by a BCR-ABL/ABL ratio < 0.01% in bone marrow d. The proportion of patients with confirmed undetectable BCR-ABL transcripts with an assay sensitivity of at least 4.5 log e. Event free survival f. Relapse free survival g. Progression free survival h. Detection of a T315I or p-loop mutation i. The proportion of patients with molecular relapse or progression j. Overall survival k. Tolerability l. Death during induction m. Death in complete remission ;Timepoint(s) of evaluation of this end point: If not defined different (see above E.5.2), the timepoints of evaluation of the scondary end points are the timepoints of bone marrow aspiration according to the protocol: After induction (week 5 of treatment), before consolidation 3 and 5 (week 16 and 24 of treatment), before Maintenance 1, 3, 5 and 7 (month 8, 12, 18, 24). | — |
Countries
Germany, Italy, Spain
Contacts
Public ContactStudienzentrale, Med. Klinik II
J.W. Goethe Universität
Outcome results
None listed