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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Ulm
• Treatments: Cytarabine; Idarubicin; Mitoxantrone; Tretinoin

Criteria

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