Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML)
NCT ID: NCT00079482
Last Updated: 2016-07-21
Study Results
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Basic Information
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COMPLETED
PHASE2
224 participants
INTERVENTIONAL
2003-10-31
2010-01-31
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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1
Induction chemotherapy with or without sequential treatment with oral CEP-701 at 80 mg bid. For patients with duration of first CR of 1 to 6 months, the induction regimen will be MEC.
CEP-701
Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
Chemotherapy
2
Induction chemotherapy with or without sequential treatment with oral CEP-701 at 80 mg bid. For patients with duration of first CR of more than 6 months to 24 months, the induction regimen will be HiDAC.
CEP-701
high-dose cytarabine
Chemotherapy
Interventions
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CEP-701
high-dose cytarabine
Chemotherapy
Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
Chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* relapsed disease following first CR of 1 month(30days)to 24 months(730days). The time from first relapse to study entry (start of first course of induction chemotherapy) must be no longer than 30days;
* confirmation of FLT-3 activating mutation positive status after point of initial relapse;
* aged 18 years or older;
* written informed consent;
* ability to understand and comply with study restrictions;
* no comorbid conditions that would limit life expectancy to less than 3 months;
* ECOG Performance Score of 0, 1,or 2;
* women must be neither pregnant nor lactating, and either of non-childbearing potential or using adequate contraception with a negative pregnancy test at study entry
Exclusion Criteria
* ALT/AST \> 3x ULN;
* serum creatinine \> 1.5 mg/dL;
* resting ejection fraction of left ventricle l \< 45%(applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine \[MEC\];
* untreated or progressive infection;
* any physical or psychiatric cdtn that may compromise participation in the study;
* known CNS involvement with AML;
* any previous treatment with a FLT-3 inhibitor;
* requires current treatment for HIV with protease inhibitors;
* active GI ulceration or bleeding;
* use of an investigational drug that is not expected to be cleared by the start of CEP-701 treatment
18 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Responsible Party
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Locations
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University of Alabama
Birmingham, Alabama, United States
Mayo-Scottsdale
Scottsdale, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
USC/Norris Cancer Center
Los Angeles, California, United States
Stanford Medical Center
Stanford, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
ACORN-Central Georgia Hematology/Oncology
Macon, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
St. Francis Cancer Care Services
Beech Grove, Indiana, United States
Indiana Cancer Pavillion
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
LSU Shreveport
Shreveport, Louisiana, United States
Univeristy of Maryland Medicine - Greenebaum Cancer Center
Baltimore, Maryland, United States
Johns Hopkins
Baltimore, Maryland, United States
Tufts New England Medical Center
Boston, Massachusetts, United States
Beth Israel Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute Wayne State University
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
The Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
New York Presbyterian
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
ACORN-The West Clinic
Memphis, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
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Sydney, New South Wales, Australia
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Herston, Queensland, Australia
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South Brisbane, Queensland, Australia
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Adelaide, South Australia, Australia
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Fitzroy, Victoria, Australia
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Melbourne, Victoria, Australia
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Perth, Western Australia, Australia
Princess Margaret Hospital
Toronto, Ontario, Canada
CHA Hospital Enfant-Jesus
Québec, Quebec, Canada
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Chemnitz, , Germany
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Dresden, , Germany
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Frankfurt, , Germany
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Heidelberg, , Germany
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Münster, , Germany
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Stuttgart, , Germany
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Haifa, , Israel
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Petah Tikva, , Israel
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Tel Litwinsky, , Israel
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Bologna, , Italy
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Roma, , Italy
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Roma, , Italy
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Turin, , Italy
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Auckland, Auckland, New Zealand
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Bialystok, , Poland
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Gdansk, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Bucharest, , Romania
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Iași, , Romania
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Moscow, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Barcelona, , Spain
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Valencia, , Spain
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Lund, , Sweden
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Stockholm, , Sweden
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Cherkassy, , Ukraine
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Kiev, , Ukraine
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Kiev, , Ukraine
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Lviv, , Ukraine
Countries
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References
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Levis M, Ravandi F, Wang ES, Baer MR, Perl A, Coutre S, Erba H, Stuart RK, Baccarani M, Cripe LD, Tallman MS, Meloni G, Godley LA, Langston AA, Amadori S, Lewis ID, Nagler A, Stone R, Yee K, Advani A, Douer D, Wiktor-Jedrzejczak W, Juliusson G, Litzow MR, Petersdorf S, Sanz M, Kantarjian HM, Sato T, Tremmel L, Bensen-Kennedy DM, Small D, Smith BD. Results from a randomized trial of salvage chemotherapy followed by lestaurtinib for patients with FLT3 mutant AML in first relapse. Blood. 2011 Mar 24;117(12):3294-301. doi: 10.1182/blood-2010-08-301796. Epub 2011 Jan 26.
Other Identifiers
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C701a/204/ON/US
Identifier Type: -
Identifier Source: org_study_id
NCT00483340
Identifier Type: -
Identifier Source: nct_alias
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