Randomized phase III study comparing the OSHO arm to the standard therapy arm of Geman AML Intergroup. Randomized comparison of Cytarabine and Mitoxantrone versus Fludarabine, Cytarabine, Mitoxantron and G-CSF treatment in patients not in remission after the first induction chemotherapy. Randomized comparison between one or two chemotherapy consolidation courses before autologous or allogeneic human stem cell transplantation in adult patients with AML under the age of 60 years.

Randomized phase III study comparing the OSHO arm to the standard therapy arm of Geman AML Intergroup. Randomized comparison of Cytarabine and Mitoxantrone versus Fludarabine, Cytarabine, Mitoxantron and G-CSF treatment in patients not in remission after the first induction chemotherapy. Randomized comparison between one or two chemotherapy consolidation courses before autologous or allogeneic human stem cell transplantation in adult patients with AML under the age of 60 years. - AML 2002 #061

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00003225

Enrollment

730

Registered

2011-08-16

Start date

2002-04-04

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

acute myeloid leukaemia C92.0

Interventions

Group 1: Cytarabine: 2 x 1 g/m²

3-h-iv infusion a 12 h

day 1+3+5+7. Mitoxantrone: 10 mg/m²

30-min-iv infusion

day 1 - 3. Group 2: Fludarabine: 2 x 15 mg/m²

day 1-5 ( 8:00 and 20:00). Cytarabine: 2 x 1 g/m²

1-h-iv infusion

day 1-5 (12:00 and 24: 00). Mitoxantrone: 7 mg/m²

day 1+3+5 (19:30). G-CSF (Neupogen): 5 µg/kg

sc or 24-h-iv infusion

day 0 up to ANC > 0,5 x 10e9/l (12:00).

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: --> age >=18 years and newly diagnosed acute myeloid leukemia as defined by new WHO classification --> Myelodysplastic Syndrome RAEB-T according to FAB-classification (blasts in bone-marrow 20-30%) --> de novo AML, secondary AML (patients with a history of myelodysplasia or other antecedent hematologic disorder for at least 6 months or therapy-related AML after previous exposure to cytotoxic drugs or radiotherapy) -->patients written informed consent

Exclusion criteria

Exclusion criteria: --> AML FAB M3 - acute promyelocyte leukemia --> involvement in other clinical trials --> contraindication to intensive chemotherapy: --> Renal failure not AML-related --> Hepatic insufficiency not AML-related --> Cardiac insufficiency NYHA III + IV --> Uncontrolled infection --> Pregnancy --> Karnofsky-performance-score 10 --> Secondary malignancies --> Severe, decompensated metabolic disorders --> HIV --> mental impairment with inability to give consent

Design outcomes

Primary

Measure	Time frame
Rate of complete remission after treatment with Cytarabine/Mitoxantrone versus Fludarabine/Cytarabine/Mitoxantrone/G-CSF given as second induction chemotherapy in patients not in remission after the first induction chemotherapy. Response assessment using bone marrow cytology is scheduled after hematological reconstitution after second induction therapy. The induction chemotherapy is finished with the second treatment course.	—

Measure

Time frame

Rate of complete remission after treatment with Cytarabine/Mitoxantrone versus Fludarabine/Cytarabine/Mitoxantrone/G-CSF given as second induction chemotherapy in patients not in remission after the first induction chemotherapy. Response assessment using bone marrow cytology is scheduled after hematological reconstitution after second induction therapy. The induction chemotherapy is finished with the second treatment course.

—

Secondary

Measure	Time frame
5-year survival and leukemia-free survival	—

Countries

Austria, Germany

Contacts

Public ContactDietger Niederwieser

Universität Leipzig Hämatologie/Onkologie

dietger@medizin.uni-leipzig.de+493419713050

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026