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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia

Thank you

Trial Information

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

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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

113 days

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

C701a/204/ON/US

NCT ID:

NCT00079482

Start Date:

October 2003

Completion Date:

January 2010

Related Keywords:

  • Acute Myeloid Leukemia
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

University of AlabamaBirmingham, Alabama  
University of MichiganAnn Arbor, Michigan  48109-0624
MD Anderson Cancer CenterHouston, Texas  77030-4096
Roswell Park Cancer InstituteBuffalo, New York  14263
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of Washington Medical CenterSeattle, Washington  98195-6043
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Emory University School of MedicineAtlanta, Georgia  30322
University of MinnesotaMinneapolis, Minnesota  55455
University of PittsburghPittsburgh, Pennsylvania  15261
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Duke University Medical CenterDurham, North Carolina  27710
Northwestern UniversityChicago, Illinois  60611
Tufts New England Medical CenterBoston, Massachusetts  02111
University of ChicagoChicago, Illinois  60637
Washington UniversitySt. Louis, Missouri  63110
The Cleveland Clinic FoundationCleveland, Ohio  
USC/Norris Cancer CenterLos Angeles, California  
Moffitt Cancer CenterTampa, Florida  33612
University of NebraskaOmaha, Nebraska  68198
Stanford Medical CenterStanford, California  94303
Mayo-ScottsdaleScottsdale, Arizona  85259
ACORN-Central Georgia Hematology/OncologyMacon, Georgia  31201
St. Francis Cancer Care ServicesBeech Grove, Indiana  46107
Indiana Cancer PavillionIndianapolis, Indiana  46202
LSU ShreveportShreveport, Louisiana  71103
Johns HopkinsBaltimore, Maryland  21231
Univeristy of Maryland Medicine - Greenebaum Cancer CenterBaltimore, Maryland  21201
Beth Israel HospitalBoston, Massachusetts  02215
Karmanos Cancer Institute Wayne State UniversityDetroit, Michigan  48201
The Mayo ClinicRochester, Minnesota  55905
New York PresbyterianNew York, New York  10021
ACORN-The West ClinicMemphis, Tennessee  38120