Study of CEP-701 in Patients With Acute Myeloid Leukemia (AML) - Full Text View

Sponsor:	Cephalon
Information provided by (Responsible Party):	Cephalon
ClinicalTrials.gov Identifier:	NCT00079482

Purpose

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	Intervention	Phase
Acute Myeloid Leukemia	Drug: lestaurtinib	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Drug Information available for: CEP 701

U.S. FDA Resources

Further study details as provided by Cephalon:

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. [ Time Frame: 113 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

- 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 ] [ Designated as safety issue: Yes ]

Enrollment:	224
Study Start Date:	October 2003
Study Completion Date:	January 2010
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: lestaurtinib lestaurtinib with induction regimen of 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: lestaurtinib lestaurtinib with induction regimen of HiDAC

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079482

Show 81 Study Locations

Sponsors and Collaborators

Cephalon

More Information

No publications provided by Cephalon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Jan 26.

Responsible Party:	Cephalon
ClinicalTrials.gov Identifier:	NCT00079482 History of Changes
Obsolete Identifiers:	NCT00483340
Other Study ID Numbers:	C701a/204/ON/US
Study First Received:	March 8, 2004
Last Updated:	August 23, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cephalon:

AML

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on February 12, 2012