Acute Myeloid Leukaemia Clinical Trial
Official title:
Randomised Comparison of OSHO Induction vs. the German AML Intergroup Standard, Randomised Comparison of AraC/Mtx vs. Flu/AraC/Mtx in Pts Without CR After One Induction Cycle and Randomized Comparison of One vs. Two Consolidation Therapies.
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
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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