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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



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