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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014