Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a

• Status: Completed
• Trial end date: 2018-07-18
• Target enrollment: 0
• Participant gender: All

Summary

Improvement of the treatment-results in elderly patients with acute myeloid leukemia through intensification of consolidation chemotherapy and/or allografting as consolidative immunotherapy

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

Details

• Lead Sponsor: University of Leipzig
• Treatments: Cytarabine

Criteria

Inclusion Criteria:

• Patients of both sexes with age > 60 years and newly diagnosed acute myeloid leukaemia as defined by new WHO classification

• written informed consent

Exclusion Criteria:

• pretreatment of leukemia

• no informed consent

• simultaneous inclusion in other studies

• mental disability

• contraindication for intensive chemotherapy

• AML FAB M3

• contraindication for allogeneic stem cell transplantation

• restriction of following organ functions:

• creatinine-clearance < 50 ml/min

• cardiac ejection fraction < 40 %

• severe pulmonary restriction

• bilirubin > 2x ULN; SGOT and SGPT > 4x ULN

• uncontrolled hypertension

• severe uncontrolled metabolism disturbance

• Karnofsky-performance-score < 70%

• hepatitis C

• other malignancy

• age of unrelated donor >70 years and age of related donor >75 years