Please select the arm or intervention descriptions that belong to the clinical trial below.
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.
Brief 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


Options:
A: Intervention Type: DRUG; Name: Cytarabine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Idarubicin; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Etoposide; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Fludarabine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: G-CSF; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Daunorubicine; Assigned to Arm(s): N/A
B: Intervention Type: DRUG; Name: Cytarabine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Thioguanine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Daunorubicin; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: G-CSF; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: Autologous stem cell transplantation; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: Allogeneic stem cell transplantation; Assigned to Arm(s): N/A
C: Intervention Type: DRUG; Name: Cytarabine vs. Cytarabine+Amsacrine+Mitoxantrone; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: early allogeneic PBSCT within induction therapy; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: autologous PBSCT; Assigned to Arm(s): N/A
D: Arm Label: Cytarabine low dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: Cytarabine | Arm Label: Cytarabine intermediate dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: Cytarabine | Intervention Type: DRUG; Name: Cytarabine; Assigned to Arm(s): Cytarabine intermediate dose, Cytarabine low dose

Answer: D