Biology and Treatment Strategy of AML in Its Subgroups: Multicenter Randomized Trial by the German Acute Myeloid Leukemia Cooperative Group (AMLCG)

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The study in patients with primary and secondary AML and high-risk MDS uses a risk-stratified, randomized design to evaluate the role of high-dose araC in induction, of G-CSF priming, and of autologous stem cell transplantation.

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

Details

• Lead Sponsor: University Hospital Muenster
• Collaborators: Deutsche Krebshilfe e.V., Bonn (Germany); German Federal Ministry of Education and Research
• Treatments: Cyclophosphamide; Cytarabine; Daunorubicin; Thioguanine

Criteria

Inclusion Criteria:

• Acute myeloid leukemia (de-novo AML, secondary AML, high-risk MDS)

• Age 16 - no upper age limit

• Written informed consent

Exclusion Criteria:

• Severe comorbidity

• Presence of other malignancy

• Prior anti-leukemic treatment

• Pregnancy

• Severe psychiatric disorder or other circumstances which may compromise cooperation of the patients