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

Phase 2
Completed
Conditions
Acute Myeloid Leukemia
Interventions
Drug: Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
Registration Number
NCT00079482
Lead Sponsor
Cephalon
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 second complete remission (CR).

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
224
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2high-dose cytarabineInduction 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.
1CEP-701Induction 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.
1Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)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.
2CEP-701Induction 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.
Primary Outcome Measures
NameTimeMethod
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.113 days
Secondary Outcome Measures
NameTimeMethod
- overall survival - event-free survival - remission duration - safety and tolerability of CEP-701 - pharmacokinetics of CEP-701 - CEP-701 inhibitory activity113 days

Trial Locations

Locations (38)

University of Alabama

🇺🇸

Birmingham, Alabama, United States

Mayo-Scottsdale

🇺🇸

Scottsdale, Arizona, United States

University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

USC/Norris Cancer Center

🇺🇸

Los Angeles, California, United States

Stanford Medical Center

🇺🇸

Stanford, California, United States

Moffitt Cancer Center

🇺🇸

Tampa, Florida, United States

Emory University School of Medicine

🇺🇸

Atlanta, Georgia, United States

ACORN-Central Georgia Hematology/Oncology

🇺🇸

Macon, Georgia, United States

Northwestern University

🇺🇸

Chicago, Illinois, United States

University of Chicago

🇺🇸

Chicago, Illinois, United States

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University of Alabama
🇺🇸Birmingham, Alabama, United States

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