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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00079482




Registration number
NCT00079482
Ethics application status
Date submitted
8/03/2004
Date registered
10/03/2004
Date last updated
21/07/2016

Titles & IDs
Public title
Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML)
Scientific 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
Secondary ID [1] 0 0
C701a/204/ON/US
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CEP-701
Treatment: Drugs - high-dose cytarabine
Treatment: Drugs - Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)

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.

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.


Treatment: Drugs: CEP-701


Treatment: Drugs: high-dose cytarabine
Chemotherapy

Treatment: Drugs: Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
Chemotherapy
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
113 days
Secondary outcome [1] 0 0
- overall survival - event-free survival - remission duration - safety and tolerability of CEP-701 - pharmacokinetics of CEP-701 - CEP-701 inhibitory activity
Timepoint [1] 0 0
113 days

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2010
Sample size
Target
Accrual to date
Final
224
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Call For Information - Sydney
Recruitment hospital [2] 0 0
Call for Information - Herston
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Call For Information - South Brisbane
Recruitment hospital [4] 0 0
Call For Information - Adelaide
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Call For Information - Fitzroy
Recruitment hospital [6] 0 0
Call For Information - Melbourne
Recruitment hospital [7] 0 0
Call For Information - Perth
Recruitment postcode(s) [1] 0 0
2065 - Sydney
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Chemnitz
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Frankfurt
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Germany
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Heidelberg
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Munster
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Stuttgart
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Haifa
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Israel
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Petah-Tiqwa
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Israel
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Tel Hashomer
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Italy
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Bologna
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Roma
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Turin
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Bialystok
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Lodz
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Kiev
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Lvov

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cephalon
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00079482
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00079482