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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
Not Enrolling
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

- 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

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:


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:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2003

Completion Date:

January 2010

Related Keywords:

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



University of Alabama Birmingham, Alabama  
University of Michigan Ann Arbor, Michigan  48109-0624
MD Anderson Cancer Center Houston, Texas  77030-4096
Roswell Park Cancer Institute Buffalo, New York  14263
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Medical University of South Carolina Charleston, South Carolina  29425-0721
University of Washington Medical Center Seattle, Washington  98195-6043
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Emory University School of Medicine Atlanta, Georgia  30322
University of Minnesota Minneapolis, Minnesota  55455
University of Pittsburgh Pittsburgh, Pennsylvania  15261
University of Pennsylvania Philadelphia, Pennsylvania  19104
Duke University Medical Center Durham, North Carolina  27710
Northwestern University Chicago, Illinois  60611
Tufts New England Medical Center Boston, Massachusetts  02111
University of Chicago Chicago, Illinois  60637
Washington University St. Louis, Missouri  63110
The Cleveland Clinic Foundation Cleveland, Ohio  
USC/Norris Cancer Center Los Angeles, California  
Moffitt Cancer Center Tampa, Florida  33612
University of Nebraska Omaha, Nebraska  68198
Stanford Medical Center Stanford, California  94303
Mayo-Scottsdale Scottsdale, Arizona  85259
ACORN-Central Georgia Hematology/Oncology Macon, Georgia  31201
St. Francis Cancer Care Services Beech Grove, Indiana  46107
Indiana Cancer Pavillion Indianapolis, Indiana  46202
LSU Shreveport Shreveport, Louisiana  71103
Johns Hopkins Baltimore, Maryland  21231
Univeristy of Maryland Medicine - Greenebaum Cancer Center Baltimore, Maryland  21201
Beth Israel Hospital Boston, Massachusetts  02215
Karmanos Cancer Institute Wayne State University Detroit, Michigan  48201
The Mayo Clinic Rochester, Minnesota  55905
New York Presbyterian New York, New York  10021
ACORN-The West Clinic Memphis, Tennessee  38120