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

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

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for:

CEP 701

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

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 ]

Estimated Enrollment:	220
Study Start Date:	October 2003
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator 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 80 Study Locations

Sponsors and Collaborators

Cephalon

More Information

Responsible Party:	Cephalon ( Sponsor's Medical Expert )
Study ID Numbers:	C701a/204/ON/US
First Received:	March 8, 2004
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00079482
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cephalon:

AML

Study placed in the following topic categories:

Leukemia

Acute myelogenous leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00079482