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

Sponsor
Cephalon (Industry)
Overall Status
Completed
CT.gov ID
NCT00079482
Collaborator
(none)
224
Enrollment
81
Locations
2
Arms
75
Duration (Months)
2.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: CEP-701
  • Drug: high-dose cytarabine
  • Drug: Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
224 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Oct 1, 2003
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Jan 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Drug: CEP-701
Other Names:
  • lestaurtinib

    • Drug: Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
    Chemotherapy
    Other Names:
  • MEC

    		•
    Active Comparator: 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.

    Drug: CEP-701
    Other Names:
  • lestaurtinib

    • Drug: high-dose cytarabine
    Chemotherapy
    Other Names:
  • HiDAC

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. - overall survival - event-free survival - remission duration - safety and tolerability of CEP-701 - pharmacokinetics of CEP-701 - CEP-701 inhibitory activity [113 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama Birmingham Alabama United States 35294
    2 Mayo-Scottsdale Scottsdale Arizona United States 85259
    3 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    4 USC/Norris Cancer Center Los Angeles California United States 90033
    5 Stanford Medical Center Stanford California United States 94305
    6 Moffitt Cancer Center Tampa Florida United States 33606
    7 Emory University School of Medicine Atlanta Georgia United States 30322
    8 ACORN-Central Georgia Hematology/Oncology Macon Georgia United States 31201
    9 Northwestern University Chicago Illinois United States 60611
    10 University of Chicago Chicago Illinois United States 60637
    11 St. Francis Cancer Care Services Beech Grove Indiana United States 46107
    12 Indiana Cancer Pavillion Indianapolis Indiana United States 46202
    13 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    14 LSU Shreveport Shreveport Louisiana United States 71103
    15 Univeristy of Maryland Medicine - Greenebaum Cancer Center Baltimore Maryland United States 21201
    16 Johns Hopkins Baltimore Maryland United States 21231
    17 Tufts New England Medical Center Boston Massachusetts United States 02111
    18 Beth Israel Hospital Boston Massachusetts United States 02215
    19 University of Michigan Ann Arbor Michigan United States 48109
    20 Karmanos Cancer Institute Wayne State University Detroit Michigan United States 48201
    21 University of Minnesota Minneapolis Minnesota United States 55455
    22 The Mayo Clinic Rochester Minnesota United States 55905
    23 Washington University St. Louis Missouri United States 63110
    24 University of Nebraska Omaha Nebraska United States 68198
    25 Roswell Park Cancer Institute Buffalo New York United States 14263
    26 New York Presbyterian New York New York United States 10021
    27 Duke University Medical Center Durham North Carolina United States 27710
    28 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
    29 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    30 University of Pittsburgh Pittsburgh Pennsylvania United States 15232
    31 Medical University of South Carolina Charleston South Carolina United States 29425
    32 ACORN-The West Clinic Memphis Tennessee United States 38120
    33 MD Anderson Cancer Center Houston Texas United States 77030
    34 University of Washington Medical Center Seattle Washington United States 98195
    35 Call For Information Sydney New South Wales Australia 2065
    36 Call for Information Herston Queensland Australia 4029
    37 Call For Information South Brisbane Queensland Australia 4101
    38 Call For Information Adelaide South Australia Australia 5000
    39 Call For Information Fitzroy Victoria Australia 3065
    40 Call For Information Melbourne Victoria Australia 3004
    41 Call For Information Perth Western Australia Australia 6000
    42 Princess Margaret Hospital Toronto Ontario Canada M5G2M9
    43 CHA Hospital Enfant-Jesus Quebec Canada G1J1Z4
    44 Call For Information Chemnitz Germany 09113
    45 Call For Information Dresden Germany 01307
    46 Call For Information Frankfurt Germany 60590
    47 Call For Information Heidelberg Germany 69120
    48 Call For Information Munster Germany 48129
    49 Call For Information Stuttgart Germany 70376
    50 Call For Information Haifa Israel 31096
    51 Call For Information Petah-Tiqwa Israel 49100
    52 Call For Information Tel Hashomer Israel 52621
    53 Call For Information Bologna Italy 41038
    54 Call For Information Roma Italy 00133
    55 Call For Information Roma Italy 00161
    56 Call For Information Turin Italy 10043
    57 Call For Information Auckland New Zealand 1023
    58 Call For Information Bialystok Poland 15276
    59 Call For Information Gdansk Poland 80952
    60 Call For Information Katowice Poland 40032
    61 Call For Information Krakow Poland 31501
    62 Call For Information Lodz Poland 93510
    63 Call For Information Lublin Poland 20022
    64 Call For Information Poznan Poland 60569
    65 Call For Information Warszawa Poland 02097
    66 Call For Information Warszawa Poland 02776
    67 Call For Information Wroclaw Poland 50369
    68 Call For Information Bucharest Romania 030171
    69 Call For Information Iasi Romania 700111
    70 Call For Information Moscow Russian Federation 125167
    71 Call For Information Novosibirsk Russian Federation 630099
    72 Call For Information St. Petersburg Russian Federation 197022
    73 Call For Information St. Petersburg Russian Federation 197110
    74 Call For Information Barcelona Spain 08041
    75 Call For Information Valencia Spain 46009
    76 Call For Information Lund Sweden SE-22185
    77 Call For Information Stockholm Sweden SE-17176
    78 Call For Information Cherkassy Ukraine 18009
    79 Call For Information Kiev Ukraine 03115
    80 Call For Information Kiev Ukraine 04112
    81 Call For Information Lvov Ukraine 79044

    Sponsors and Collaborators

    • Cephalon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cephalon
    ClinicalTrials.gov Identifier:
    NCT00079482
    Other Study ID Numbers:
    • C701a/204/ON/US
    • NCT00483340
    First Posted:
    Mar 10, 2004
    Last Update Posted:
    Jul 21, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by Cephalon
    AML
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Cytarabine
    Etoposide
    Mitoxantrone

    Study Results

    No Results Posted as of Jul 21, 2016