Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity)
NCT ID: NCT00124748
Last Updated: 2012-02-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
476 participants
INTERVENTIONAL
2005-06-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Imatinib 400 mg
Oral dose of 400mg Imatinib once daily. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
Imatinib mesylate
Imatinib is packaged in bottles as 100mg and 400mg tablets
imatinib 800 mg
Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
Imatinib mesylate
Imatinib is packaged in bottles as 100mg and 400mg tablets
Interventions
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Imatinib mesylate
Imatinib is packaged in bottles as 100mg and 400mg tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of South Alabama
Mobile, Alabama, United States
Alta Bates Comprehsenive Cancer Center
Berkeley, California, United States
University of Miami
Berkeley, California, United States
South Bay Oncology Hematology Partners
Campbell, California, United States
UCLA Medical Center
Los Angeles, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Osler Medical Inc.
Melbourne, Florida, United States
Advanced Medical Specialists
Miami, Florida, United States
Integrated Community Oncology Network
Orange Park, Florida, United States
Hematology-Oncology Associates, P.A.
Pensacola, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana Blood and Marrow Institutw
Beech Grove, Indiana, United States
Indiana Blood and Marrow Transplant
Beech Grove, Indiana, United States
University of Iowa Hospitals & Clinic
Iowa City, Iowa, United States
University of Kentucky - C201 Clinic
Lexington, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
Lousville Oncology, Clinical Research Program M-25
Louisville, Kentucky, United States
Jayne S. Gurtler, MD, Laura A. Brinz, MD & Angelo Russo, MD
Metairie, Louisiana, United States
Hematology and Oncology Specialists
New Orleans, Louisiana, United States
LSU Health Science Center
Shreveport, Louisiana, United States
LSU Health Scine Center
Shreveport, Louisiana, United States
St. Agnes Hospital
Baltimore, Maryland, United States
Great Lakes Cancer Institute
Lansing, Michigan, United States
U of Minnesota
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cancer Center of the Carolinas
Greenville, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University Hospitals of Cleveland, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Kaiser Permanente Northwest Region Oncology/Hemacology
Portland, Oregon, United States
Kaiser Permanente Northwest Region
Portland, Oregon, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburg, Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, United States
Cancer Center of the Carolinas
Greenville, South Carolina, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
The Jones Clinic
Germantown, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
UT Southwestern Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, United States
University of Texas / MD Anderson Cancer Center
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Virgina Cancer Center, UVA Division of Hematology & Oncology
Charlottesville, Virginia, United States
Novartis Investigative Site
Buenos Aires, , Argentina
Novartis Investigative Site
La Plata, , Argentina
Novartis Investigative Site
St Leonards, New South Wales, Australia
Novartis Investigative Site
Waratah, New South Wales, Australia
Novartis Investigative Site
Westmead, New South Wales, Australia
Novartis Investigative Site
Herston, Queensland, Australia
Novartis Investigative Site
Woolloongabba, Queensland, Australia
Novartis Investigative Site
Adelaide, South Australia, Australia
Novartis Investigative Site
East Melbourne, Victoria, Australia
Novartis Investigative Site
Fitzroy, Victoria, Australia
Novartis Investigative Site
Frankston, Victoria, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Prahran, Victoria, Australia
Novartis Investigative Site
South Brisbane, , Australia
Novartis Investigative Site
Campinas, , Brazil
Novartis Investigative Site
Calgary, , Canada
Novartis Investigative Site
Montreal, , Canada
Novartis Investigative Site
Ottawa, , Canada
Novartis Investigative Site
Québec, , Canada
Novartis Investigative Site
Bologna, , Italy
Novartis Investigative Site
Florence, , Italy
Novartis Investigative Site
Milan, , Italy
Novartis Investigative Site
Napoli, , Italy
Novartis Investigative Site
Orbassano, , Italy
Novartis Investigative Site
Roma, , Italy
Countries
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References
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Branford S, Yeung DT, Parker WT, Roberts ND, Purins L, Braley JA, Altamura HK, Yeoman AL, Georgievski J, Jamison BA, Phillis S, Donaldson Z, Leong M, Fletcher L, Seymour JF, Grigg AP, Ross DM, Hughes TP. Prognosis for patients with CML and >10% BCR-ABL1 after 3 months of imatinib depends on the rate of BCR-ABL1 decline. Blood. 2014 Jul 24;124(4):511-8. doi: 10.1182/blood-2014-03-566323. Epub 2014 May 23.
Branford S, Yeung DT, Ross DM, Prime JA, Field CR, Altamura HK, Yeoman AL, Georgievski J, Jamison BA, Phillis S, Sullivan B, Briggs NE, Hertzberg M, Seymour JF, Reynolds J, Hughes TP. Early molecular response and female sex strongly predict stable undetectable BCR-ABL1, the criteria for imatinib discontinuation in patients with CML. Blood. 2013 May 9;121(19):3818-24. doi: 10.1182/blood-2012-10-462291. Epub 2013 Mar 20.
Guilhot F, Hughes TP, Cortes J, Druker BJ, Baccarani M, Gathmann I, Hayes M, Granvil C, Wang Y. Plasma exposure of imatinib and its correlation with clinical response in the Tyrosine Kinase Inhibitor Optimization and Selectivity Trial. Haematologica. 2012 May;97(5):731-8. doi: 10.3324/haematol.2011.045666. Epub 2012 Feb 7.
Related Links
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Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Other Identifiers
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CSTI571K2301
Identifier Type: -
Identifier Source: org_study_id
NCT00324636
Identifier Type: -
Identifier Source: nct_alias
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