Definitions:
A case was defined as primary refractory, if the patient had not
responded to at least one previous standard of care chemotherapy.
A case was defined as relapsed, if the patient had initially achieved a
morphologic complete remission after a standard of care chemotherapy and
then had experienced a relapse of the leukemia (morphologic complete
remission defined as <5% leukemic cells in bone marrow). The
event free survival (EFS) was defined as the time period from the first
day of the first cycle of melphalan / cytarabine to the date of relapse,
death or last follow-up.
The overall survival (OS) was defined as the time period from the first
day of the first cycle of melphalan / cytarabine to the date of death or
last follow-up. In case of death during the observation period the cause
of death was subdivided into disease-related mortality and
therapy-related mortality.
Treatment failure was defined as absence of complete remission without
the possibility to proceed to an allogeneic hematopoietic stem cell
transplantation.