Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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 - 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: 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
Recruitment hospital [3] 0 0
Call For Information - South Brisbane
Recruitment hospital [4] 0 0
Call For Information - Adelaide
Recruitment hospital [5] 0 0
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Germany
State/province [27] 0 0
Chemnitz
Country [28] 0 0
Germany
State/province [28] 0 0
Dresden
Country [29] 0 0
Germany
State/province [29] 0 0
Frankfurt
Country [30] 0 0
Germany
State/province [30] 0 0
Heidelberg
Country [31] 0 0
Germany
State/province [31] 0 0
Munster
Country [32] 0 0
Germany
State/province [32] 0 0
Stuttgart
Country [33] 0 0
Israel
State/province [33] 0 0
Haifa
Country [34] 0 0
Israel
State/province [34] 0 0
Petah-Tiqwa
Country [35] 0 0
Israel
State/province [35] 0 0
Tel Hashomer
Country [36] 0 0
Italy
State/province [36] 0 0
Bologna
Country [37] 0 0
Italy
State/province [37] 0 0
Roma
Country [38] 0 0
Italy
State/province [38] 0 0
Turin
Country [39] 0 0
New Zealand
State/province [39] 0 0
Auckland
Country [40] 0 0
Poland
State/province [40] 0 0
Bialystok
Country [41] 0 0
Poland
State/province [41] 0 0
Gdansk
Country [42] 0 0
Poland
State/province [42] 0 0
Katowice
Country [43] 0 0
Poland
State/province [43] 0 0
Krakow
Country [44] 0 0
Poland
State/province [44] 0 0
Lodz
Country [45] 0 0
Poland
State/province [45] 0 0
Lublin
Country [46] 0 0
Poland
State/province [46] 0 0
Poznan
Country [47] 0 0
Poland
State/province [47] 0 0
Warszawa
Country [48] 0 0
Poland
State/province [48] 0 0
Wroclaw
Country [49] 0 0
Romania
State/province [49] 0 0
Bucharest
Country [50] 0 0
Romania
State/province [50] 0 0
Iasi
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Moscow
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Novosibirsk
Country [53] 0 0
Russian Federation
State/province [53] 0 0
St. Petersburg
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelona
Country [55] 0 0
Spain
State/province [55] 0 0
Valencia
Country [56] 0 0
Sweden
State/province [56] 0 0
Lund
Country [57] 0 0
Sweden
State/province [57] 0 0
Stockholm
Country [58] 0 0
Ukraine
State/province [58] 0 0
Cherkassy
Country [59] 0 0
Ukraine
State/province [59] 0 0
Kiev
Country [60] 0 0
Ukraine
State/province [60] 0 0
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/study/NCT00079482
Trial related presentations / publications
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.
Public notes

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



Summary Results

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