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

NCT ID: NCT00154349

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2007-02-28

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).

Conditions

Philadelphia Chromosome Positive Acute Lymphocytic Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

imatinib mesylate

Group Type: EXPERIMENTAL

Imatinib Mesylate

Intervention Type: DRUG

Interventions

Imatinib Mesylate

Intervention Type: DRUG

Other Intervention Names

STI571,; Glivec,; Gleevec

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

CSTI571I1203

Identifier Type: -

Identifier Source: org_study_id