NCT00079482

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	CEP-701
DRUG	high-dose cytarabine	Chemotherapy
DRUG	Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)	Chemotherapy

Timeline

• Start date: 2003-10-01
• Primary completion: 2009-03-01
• Completion: 2010-01-01
• First posted: 2004-03-10
• Last updated: 2016-07-21

Locations

81 sites across 13 countries: United States, Australia, Canada, Germany, Israel, Italy, New Zealand, Poland, Romania, Russia, Spain, Sweden, Ukraine