Status:
TERMINATED
Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Leukemia, Myeloid, Chronic Phase
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
476 Patients enrolled
Trial Details
Trial ID
NCT00124748
Start Date
June 1 2005
End Date
November 1 2010
Last Update
February 3 2012
Active Locations (75)
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1
University of South Alabama
Mobile, Alabama, United States, 36693
2
Alta Bates Comprehsenive Cancer Center
Berkeley, California, United States, 94704
3
University of Miami
Berkeley, California, United States, 94704
4
South Bay Oncology Hematology Partners
Campbell, California, United States, 95008