Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity)

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

• Patients within 6 months of diagnosis (date of initial diagnosis is the date of first cytogenetic analysis)

• Diagnosis of chronic myelogenous leukemia (CML) in chronic phase with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations and presence of Breakpoint cluster region gene-abelson proto-oncogene (Bcr-Abl)

• Documented chronic phase CML

• Adequate end organ function as defined by:

• total bilirubin < 1.5 x Upper Limit of Normal (ULN)

• Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 2.5 x ULN

• creatinine < 1.5 x ULN

Exclusion Criteria:

• Patients in late chronic phase, accelerated phase, or blastic phase are excluded

• Patients who have received other investigational agents

• Patients who received Gleevec/Glivec for any duration prior to study entry, with the exception of those patients successfully completing [CSTI571A2107 (NCT00428909)] study immediately prior to the participation in this study

• Patient received any treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide

• Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention

• Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to baseline and (d) male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).

• Patient with a severe or uncontrolled medical condition (i.e., uncontrolled diabetes,chronic renal disease)

• Patient previously received radiotherapy to ≥ 25% of the bone marrow

• Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery

• Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status Score ≥ 3

• Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x ULN, with the exception of patients on treatment with oral anticoagulants

• Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required

• Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment

Other protocol-defined inclusion/exclusion criteria applied.