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Status:

COMPLETED

Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML)

Lead Sponsor:

Cephalon

Conditions:

Acute Myeloid Leukemia

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 sec...

Detailed Description

Patients randomly assigned to chemotherapy alone received the second course of induction chemotherapy as soon as clinically indicated; patients randomly assigned to receive chemotherapy plus sequentia...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2010

    Estimated Enrollment :

    224 Patients enrolled

    Trial Details

    Trial ID

    NCT00079482

    Start Date

    October 1 2003

    End Date

    January 1 2010

    Last Update

    July 21 2016

    Active Locations (81)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 21 (81 locations)

    1

    University of Alabama

    Birmingham, Alabama, United States, 35294

    2

    Mayo-Scottsdale

    Scottsdale, Arizona, United States, 85259

    3

    University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205

    4

    USC/Norris Cancer Center

    Los Angeles, California, United States, 90033