Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML)
A Randomized, Open-Label Study of Oral CEP-701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia (AML) Expressing FLT-3 Activating Mutations
1 other identifier
interventional
224
13 countries
81
Brief Summary
The purpose of the study is to determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2003
Longer than P75 for phase_2
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 8, 2004
CompletedFirst Posted
Study publicly available on registry
March 10, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedJuly 21, 2016
July 1, 2016
5.4 years
March 8, 2004
July 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed AML who achieve a second complete remission or a complete remission with incomplete platelet count recovery.
113 days
Secondary Outcomes (1)
- overall survival - event-free survival - remission duration - safety and tolerability of CEP-701 - pharmacokinetics of CEP-701 - CEP-701 inhibitory activity
113 days
Study Arms (2)
1
ACTIVE COMPARATORInduction 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.
2
ACTIVE COMPARATORInduction 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.
Interventions
Eligibility Criteria
You may qualify if:
- cytological confirmation of AML;
- 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
You may not qualify if:
- bilirubin \> 2x ULN;
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (81)
University of Alabama
Birmingham, Alabama, 35294, United States
Mayo-Scottsdale
Scottsdale, Arizona, 85259, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
USC/Norris Cancer Center
Los Angeles, California, 90033, United States
Stanford Medical Center
Stanford, California, 94305, United States
Moffitt Cancer Center
Tampa, Florida, 33606, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
ACORN-Central Georgia Hematology/Oncology
Macon, Georgia, 31201, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
St. Francis Cancer Care Services
Beech Grove, Indiana, 46107, United States
Indiana Cancer Pavillion
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
LSU Shreveport
Shreveport, Louisiana, 71103, United States
Univeristy of Maryland Medicine - Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Johns Hopkins
Baltimore, Maryland, 21231, United States
Tufts New England Medical Center
Boston, Massachusetts, 02111, United States
Beth Israel Hospital
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute Wayne State University
Detroit, Michigan, 48201, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
The Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63110, United States
University of Nebraska
Omaha, Nebraska, 68198, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
New York Presbyterian
New York, New York, 10021, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
ACORN-The West Clinic
Memphis, Tennessee, 38120, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
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Sydney, New South Wales, 2065, Australia
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Herston, Queensland, 4029, Australia
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South Brisbane, Queensland, 4101, Australia
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Adelaide, South Australia, 5000, Australia
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Fitzroy, Victoria, 3065, Australia
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Melbourne, Victoria, 3004, Australia
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Perth, Western Australia, 6000, Australia
Princess Margaret Hospital
Toronto, Ontario, M5G2M9, Canada
CHA Hospital Enfant-Jesus
Québec, Quebec, G1J1Z4, Canada
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Chemnitz, 09113, Germany
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Dresden, 01307, Germany
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Frankfurt, 60590, Germany
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Heidelberg, 69120, Germany
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Münster, 48129, Germany
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Stuttgart, 70376, Germany
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Haifa, 31096, Israel
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Petah Tikva, 49100, Israel
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Tel Litwinsky, 52621, Israel
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Bologna, 41038, Italy
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Roma, 00133, Italy
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Roma, 00161, Italy
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Turin, 10043, Italy
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Auckland, Auckland, 1023, New Zealand
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Bialystok, 15276, Poland
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Gdansk, 80952, Poland
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Katowice, 40032, Poland
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Krakow, 31501, Poland
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Lodz, 93510, Poland
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Lublin, 20022, Poland
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Poznan, 60569, Poland
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Warsaw, 02097, Poland
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Warsaw, 02776, Poland
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Wroclaw, 50369, Poland
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Bucharest, 030171, Romania
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Iași, 700111, Romania
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Moscow, 125167, Russia
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Novosibirsk, 630099, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197110, Russia
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Barcelona, 08041, Spain
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Valencia, 46009, Spain
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Lund, SE-22185, Sweden
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Stockholm, SE-17176, Sweden
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Cherkassy, 18009, Ukraine
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Kiev, 03115, Ukraine
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Kiev, 04112, Ukraine
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Lviv, 79044, Ukraine
Related Publications (1)
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.
PMID: 21270442DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2004
First Posted
March 10, 2004
Study Start
October 1, 2003
Primary Completion
March 1, 2009
Study Completion
January 1, 2010
Last Updated
July 21, 2016
Record last verified: 2016-07