All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

University of Ulm

Status and phase: Completed; Phase 3

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Cytarabine; Drug: Etoposid; Drug: Idarubicin; Drug: Mitoxantrone; Drug: All-trans retinoic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00151255

AMLSG06-04

Details and patient eligibility

About

This is a study looking at all-trans retinoic acid in combination with standard induction and consolidation therapy in older patients with newly diagnosed acute myeloid leukemia (AML).

Full description

First Induction Therapy:

Cytarabine 100 mg/m² cont. i.v. days 1-5

Idarubicin 12 mg/m² i.v. days 1, 3

ATRA 45 mg/m² p.o. days 4-6, ATRA 15 mg/m² p.o. days 7-28

Second Induction Therapy:

Cytarabine 100 mg/m² cont. i.v. days 1-5

Idarubicin 12 mg/m² i.v. days 1, 3

ATRA 45 mg/m² p.o. days 4-6, ATRA 15 mg/m² p.o. days 7-28

First Consolidation Therapy:

Cytarabine 1000 mg/m² bid i.v. days 1-3

Mitoxantrone 10 mg/m² i.v. days 2, 3

ATRA 15 mg/m² p.o. days 4-28

Second Consolidation Therapy

Etoposide 100 mg/m² i.v. days 1-5

Idarubicin 12 mg/m² i.v. days 1,3

ATRA 15 mg/m² p.o. days 4-28

Enrollment: 500 estimated patients

Sex: All

Ages: 61+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed AML defined according to the World Health Organization (WHO) classification (excluding acute promyelocytic leukemia [APL])
• Aged > 60 years
• All patients have to be informed about the character of the study. Written informed consent of each patient at study entry.
• Molecular and cytogenetical analyses on initial bone marrow and peripheral blood specimen have to be performed at the central reference laboratories.

Exclusion criteria

• Bleeding independent of the AML
• Acute promyelocytic leukemia
• Uncontrolled infection
• Participation in a concurrent clinical study
• Insufficiency of the kidneys (creatinine > 1.5 x upper normal serum level), of the liver (bilirubin, AST or AP > 2 x upper normal serum level), severe obstruction or restrictive ventilation disorder, heart failure New York Heart Association [NYHA] III/IV
• Severe neurological or psychiatric disorder interfering with ability of giving informed consent
• No consent for the registration, storage and processing of data concerning the characteristics of the AML and the individual course
• Performance status WHO > 2

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)