Curative and palliative treatment of adults aged > 60 years with AML.A randomised trial by OSHO on the role of (1) early intensification {OSHO protocol} vs. common standard arm of German AML Intergroup Study, (2) allografting as consolidative immunotherapy vs. a second consolidation course in elderly patients,(3) prospective evaluation of the decision between curative and palliative treatment-intention. - AML 2004 OSHO #069

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002833-10-AT

Enrollment

330

Registered

2006-01-02

Start date

2006-03-08

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myelogenous leukemia

Interventions

Trade Name: Mitoxantron Product Name: Mitoxantron Pharmaceutical Form: Concentrate for solution for infusion Trade Name: Cytarabin Product Name: Cytarabin Pharmaceutical Form: Powder for infusion* T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: AML according to the WHO classification (1999) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Acute promyelocytic leukemie (APL; t(15;17))

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. Comparison of EFS of OSHO arm versus standard arm of German AML Intergroup Study 2. Comparison of LFS and OS after allogeneic transplantation given as second consolidation versus a second chemotherapy consolidation course;Secondary Objective: ;Primary end point(s): Event free survival	—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 20, 2026