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: Idarubicin

Drug: Etoposid

Drug: All-trans retinoic acid

Drug: Mitoxantrone

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