Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML<60a
Status:
Unknown status
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
This protocol is part of the German AML Intergroup Trial, where the OSHO study arm is
compared to the common German standard arm after randomization in a 9:1 ratio. The hypothesis
involves primarily dosing and application of AraC for induction. It is expected that CR rates
and as a consequence also LFS are higher in protocols using higher AraC compared to lower
doses and that LFS might be superior in the study specific arm compared to the golden
standard published several years ago. In the standard arm, AraC 100mg/m2/day is given as
continuous infusion over 7 days. Daunorubicin is given as 60 mg/m2/day over a two hours
infusion on days 3, 4 und 5. On day 22 a second induction course is applied. After reaching
CR, three cycles of AraC 3 g/m2 over three hours bid are infused on day 1, 3 und 5. In
contrast the OSHO arm consists of induction therapy with IDA 12 mg/m*2 over 20-30-min-iv on
day 1 - 3 and AraC 2 x 1 g/m*2 bid over 3-h-iv on days 1+3+5+7.
A previous phase II study of the OSHO has shown high CR in patients with relapsed AML using
MitoFlag. In this study we asked the question if MitoFlag is superior to IdaAraC in newly
diagnosed AML patients without CR after the first induction chemotherapy. Therefore patients
are randomized to receive either MitoFlag or IdaAraC and the difference in CR rates
evaluated.
It is still unclear if two consolidation therapies are needed before allogeneic or autologous
stem cell transplantation. This question is being addressed in the second part of the OSHO
study, where patients are randomized to receive either one or two consolidation therapies.
In this study all patients with AML and an age of 18-60 years except M3 are entered