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Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML)

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CEP-701
high-dose cytarabine
Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
Sponsored by
Cephalon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: 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 Exclusion criteria: 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

Sites / Locations

  • University of Alabama
  • Mayo-Scottsdale
  • University of Arkansas for Medical Sciences
  • USC/Norris Cancer Center
  • Stanford Medical Center
  • Moffitt Cancer Center
  • Emory University School of Medicine
  • ACORN-Central Georgia Hematology/Oncology
  • Northwestern University
  • University of Chicago
  • St. Francis Cancer Care Services
  • Indiana Cancer Pavillion
  • University of Iowa Hospitals and Clinics
  • LSU Shreveport
  • Univeristy of Maryland Medicine - Greenebaum Cancer Center
  • Johns Hopkins
  • Tufts New England Medical Center
  • Beth Israel Hospital
  • University of Michigan
  • Karmanos Cancer Institute Wayne State University
  • University of Minnesota
  • The Mayo Clinic
  • Washington University
  • University of Nebraska
  • Roswell Park Cancer Institute
  • New York Presbyterian
  • Duke University Medical Center
  • The Cleveland Clinic Foundation
  • University of Pennsylvania
  • University of Pittsburgh
  • Medical University of South Carolina
  • ACORN-The West Clinic
  • MD Anderson Cancer Center
  • University of Washington Medical Center
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  • Princess Margaret Hospital
  • CHA Hospital Enfant-Jesus
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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

- overall survival - event-free survival - remission duration - safety and tolerability of CEP-701 - pharmacokinetics of CEP-701 - CEP-701 inhibitory activity

Full Information

First Posted
March 8, 2004
Last Updated
July 19, 2016
Sponsor
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00079482
Brief Title
Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cephalon

4. Oversight

5. Study Description

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).
Detailed Description
Patients randomly assigned to chemotherapy alone received the second course of induction chemotherapy as soon as clinically indicated; patients randomly assigned to receive chemotherapy plus sequential lestaurtinib had lestaurtinib withheld for 3 days (72 hours) before the start of the second 5-day course of chemotherapy and resumed lestaurtinib treatment 2 days (48 hours) after the final administration of the second course of chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CEP-701
Other Intervention Name(s)
lestaurtinib
Intervention Type
Drug
Intervention Name(s)
high-dose cytarabine
Other Intervention Name(s)
HiDAC
Intervention Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
Other Intervention Name(s)
MEC
Intervention Description
Chemotherapy
Primary Outcome Measure Information:
Title
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.
Time Frame
113 days
Secondary Outcome Measure Information:
Title
- overall survival - event-free survival - remission duration - safety and tolerability of CEP-701 - pharmacokinetics of CEP-701 - CEP-701 inhibitory activity
Time Frame
113 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 Exclusion criteria: 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
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo-Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
USC/Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Stanford Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
ACORN-Central Georgia Hematology/Oncology
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
St. Francis Cancer Care Services
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Indiana Cancer Pavillion
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
LSU Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Univeristy of Maryland Medicine - Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Tufts New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Beth Israel Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Karmanos Cancer Institute Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
The Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
New York Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
ACORN-The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Call For Information
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Call for Information
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Call For Information
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Call For Information
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Call For Information
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Call For Information
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Call For Information
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
CHA Hospital Enfant-Jesus
City
Quebec
ZIP/Postal Code
G1J1Z4
Country
Canada
Facility Name
Call For Information
City
Chemnitz
ZIP/Postal Code
09113
Country
Germany
Facility Name
Call For Information
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Call For Information
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Call For Information
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Call For Information
City
Munster
ZIP/Postal Code
48129
Country
Germany
Facility Name
Call For Information
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Call For Information
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Call For Information
City
Petah-Tiqwa
ZIP/Postal Code
49100
Country
Israel
Facility Name
Call For Information
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Call For Information
City
Bologna
ZIP/Postal Code
41038
Country
Italy
Facility Name
Call For Information
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Call For Information
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Call For Information
City
Turin
ZIP/Postal Code
10043
Country
Italy
Facility Name
Call For Information
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Call For Information
City
Bialystok
ZIP/Postal Code
15276
Country
Poland
Facility Name
Call For Information
City
Gdansk
ZIP/Postal Code
80952
Country
Poland
Facility Name
Call For Information
City
Katowice
ZIP/Postal Code
40032
Country
Poland
Facility Name
Call For Information
City
Krakow
ZIP/Postal Code
31501
Country
Poland
Facility Name
Call For Information
City
Lodz
ZIP/Postal Code
93510
Country
Poland
Facility Name
Call For Information
City
Lublin
ZIP/Postal Code
20022
Country
Poland
Facility Name
Call For Information
City
Poznan
ZIP/Postal Code
60569
Country
Poland
Facility Name
Call For Information
City
Warszawa
ZIP/Postal Code
02097
Country
Poland
Facility Name
Call For Information
City
Warszawa
ZIP/Postal Code
02776
Country
Poland
Facility Name
Call For Information
City
Wroclaw
ZIP/Postal Code
50369
Country
Poland
Facility Name
Call For Information
City
Bucharest
ZIP/Postal Code
030171
Country
Romania
Facility Name
Call For Information
City
Iasi
ZIP/Postal Code
700111
Country
Romania
Facility Name
Call For Information
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Call For Information
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Call For Information
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Call For Information
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Call For Information
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Call For Information
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Call For Information
City
Lund
ZIP/Postal Code
SE-22185
Country
Sweden
Facility Name
Call For Information
City
Stockholm
ZIP/Postal Code
SE-17176
Country
Sweden
Facility Name
Call For Information
City
Cherkassy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Call For Information
City
Kiev
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Call For Information
City
Kiev
ZIP/Postal Code
04112
Country
Ukraine
Facility Name
Call For Information
City
Lvov
ZIP/Postal Code
79044
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
21270442
Citation
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.
Results Reference
derived

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Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML)

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