Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia

Novartis Pharmaceuticals0 sites8 target enrollmentOctober 2003

ConditionsPhiladelphia Chromosome Positive Acute Lymphocytic Leukemia

InterventionsImatinib Mesylate

DrugsImatinib Mesylate

Overview

Phase: Phase 2
Intervention: Imatinib Mesylate
Conditions: Philadelphia Chromosome Positive Acute Lymphocytic Leukemia
Sponsor: Novartis Pharmaceuticals
Enrollment: 8
Primary Endpoint: 3 month hematological response rate
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The objective of this study is to determine the efficacy and safety of imatinib mesylate in patients diagnosed as having Philadelphia chromosome positive acute lymphocytic leukemia (ALL).

Registry

clinicaltrials.gov

Start Date

October 2003

End Date

February 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.
•Other protocol-defined inclusion/exclusion criteria may apply.