Philadelphia Chromosome Positive Acute Lymphocytic Leukemia (Ph+ALL)
Conditions
Interventions
Trade Name: Glivec
Product Name: Imatinib Mesylate
Product Code: STI571
Pharmaceutical Form: Capsule
INN or Proposed INN: IMATINIB MESILATE
CAS Number: 220127-57-1
Current Sponsor code: STI571
Concent
Sponsors
Novartis Pharma K.K
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed diagnosis of Ph+ or bcr-abl + ALL. Refractory to or ineligible for initial remission induction therapy remission induction therapy Patients with histologically confirmed diagnosis of ALL. •Patients confirmed to be Ph chromosome positive or bcr-abl gene positive. •Patients in relapse •Patients refractory to initial remission induction therapy •Patients ineligible for initial remission induction therapy •Patients with an ECOG Performance Status Score from 0 to 2 •Serum creatinine concentration of not more than 2 × the upper limit of the normal range (ULN) •AST (SGOT) and ALT (SGPT) of not more than 3 × ULN. In patients with hepatic dysfunction from leukemic involvement, AST (SGOT) and ALT (SGPT) should be not more than 5 × ULN •Serum bilirubin level not more than 3 × ULN Are the trial subjects under 18? yes Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: to receive any hematopoietic stem cell transplantation within 6 weeks of the planned initiation of the study drug Patients with findings indicative of leukemic involvement of the central nervous system •Patients with any serious concomitant medical condition (e.g., poorly controllable infection, interstitial pneumonia, pulmonary fibrosis, congestive cardiac failure, poorly controlled diabetes mellitus, mental disorder) •Patients expected to receive any hematopoietic stem cell transplantation within 6 weeks of the planned initiation of the study drug •Patients having received any hematopoietic stem cell transplantation who have a Grade 3 or 4 GVHD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy (hematologic response) of STI571 in patients diagnosed Philadelphia-Positive Acute Lymphocytic Leukemia (Ph+ALL);Secondary Objective: To evaluate efficacy (response of duration, cytogenetic response) and safety of STI571 in patients diagnosed Philadelphia-Positive Acute Lymphocytic Leukemia (Ph+ALL) ;Primary end point(s): To evaluate hematologic response to STI571 in patients diagnosed Philadelphia-Positive Acute Lymphocytic Leukemia (Ph+ALL);Timepoint(s) of evaluation of this end point: Every 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Every 4 weeks;Secondary end point(s): To valuate cytogenetic response, physical and laboratory evaluations, adverse event monitoring, and ECGs | — |
Countries
Japan
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed