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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT00079482
First received: March 8, 2004
Last updated: August 27, 2013
Last verified: August 2013
  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 2

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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

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 ]

Enrollment: 224
Study Start Date: October 2003
Study Completion Date: January 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Active Comparator: 2
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 81 Study Locations
Sponsors and Collaborators
Cephalon
  More Information

No publications provided by Teva Pharmaceutical Industries

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00079482     History of Changes
Obsolete Identifiers: NCT00483340
Other Study ID Numbers: C701a/204/ON/US
Study First Received: March 8, 2004
Last Updated: August 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 15, 2014