Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is a study on all-trans retinoic acid in combination with induction and consolidation therapy as well as pegfilgrastim after consolidation therapy in younger patients with newly diagnosed acute myeloid leukemia (AML).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Newly diagnosed AML defined according to the World Health Organization (WHO)-classification (excluding acute promyelocytic leukemia [APL])

• Ages 18-60 years

• Written informed consent of each patient at study entry.

• Molecular and cytogenetical diagnostics on initial bone marrow and peripheral blood specimen at the central reference laboratories

Exclusion Criteria:

• Bleeding independent of the AML

• Acute promyelocytic leukemia

• Uncontrollable infection

• Participation in a concurrent clinical study

• Insufficiency of the kidneys (creatinine > 1.5x upper normal serum level), of the liver (bilirubin, AST or AP > 2x upper normal serum level), severe obstructive or restrictive ventilation disorder, heart failure New York Heart Association (NYHA) III/IV

• Severe neurological or psychiatric disorder interfering with ability to give an informed consent.

• No consent for registration, storage and processing of the individual disease-characteristics and course.

• Performance status WHO > 2

• Pregnancy