Study of CEP-701 (Lestaurtinib) 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: July 19, 2016
Last verified: July 2016
  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: CEP-701
Drug: high-dose cytarabine
Drug: Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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: CEP-701
Other Name: lestaurtinib
Drug: Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
Chemotherapy
Other Name: 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: CEP-701
Other Name: lestaurtinib
Drug: high-dose cytarabine
Chemotherapy
Other Name: HiDAC

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 sequential lestaurtinib had lestaurtinib withheld for 3 days (72 hours) before the start of the second 5-day course of chemotherapy and resumed lestaurtinib treatment 2 days (48 hours) after the final administration of the second course of chemotherapy.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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: July 19, 2016
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 by Histologic Type
Neoplasms
Etoposide
Mitoxantrone
Cytarabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 21, 2016