Efficacy Study of Imatinib Mesylate to Treat Philadelphia-Positive Acute Lymphocytic Leukemia

Phase 2

Completed

• Conditions: Philadelphia Chromosome Positive Acute Lymphocytic Leukemia
• Interventions: Drug: Imatinib Mesylate

• Registration Number: NCT00154349
• Lead Sponsor: Novartis Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
imatinib mesylate	Imatinib Mesylate	-

Primary Outcome Measures

Name	Time	Method
3 month hematological response rate

Secondary Outcome Measures

Name	Time	Method
Duration of hematological response
Survival
Cytogenetic response in every 3 months