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

Cephalon

Status and phase: Completed; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy); Drug: high-dose cytarabine; Drug: CEP-701

Study type: Interventional

Funder types: Industry

Identifiers

NCT00079482

C701a/204/ON/US

Details and patient eligibility

About

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).

Full 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.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

1

Active Comparator group

Description:

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.

Treatment:

Drug: CEP-701

Drug: Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)

2

Active Comparator group

Description:

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.

Treatment:

Drug: CEP-701

Drug: high-dose cytarabine