Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a (AML2004)

University of Leipzig

Status and phase: Completed; Phase 3

Conditions: Acute Myeloid Leukaemia

Treatments: Biological: human stem cells; Drug: Cytarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01497002

OSHO#069

Details and patient eligibility

About

Improvement of the treatment-results in elderly patients with acute myeloid leukemia through intensification of consolidation chemotherapy and/or allografting as consolidative immunotherapy

Full description

Measuring EFS depending on induction therapy

Enrollment: 1,222 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of both sexes with age > 60 years and newly diagnosed acute myeloid leukaemia as defined by new WHO classification
• written informed consent

Exclusion criteria

• pretreatment of leukemia
• no informed consent
• simultaneous inclusion in other studies
• mental disability
• contraindication for intensive chemotherapy
• AML FAB M3
• contraindication for allogeneic stem cell transplantation
• restriction of following organ functions:
• creatinine-clearance < 50 ml/min
• cardiac ejection fraction < 40 %
• severe pulmonary restriction
• bilirubin > 2x ULN; SGOT and SGPT > 4x ULN
• uncontrolled hypertension
• severe uncontrolled metabolism disturbance
• Karnofsky-performance-score < 70%
• hepatitis C
• other malignancy
• age of unrelated donor >70 years and age of related donor >75 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,222 participants in 3 patient groups

standard arm

Active Comparator group

Description:

standard treatment arm

Treatment:

Drug: Cytarabine

OSHO - intensified consolidation

Experimental group

Description:

Intermediate dose AraC

Treatment:

Drug: Cytarabine

OSHO - allografting as consolidation

Experimental group

Description:

allogeneic stem cell Transplantation versus no transplantation

Treatment:

Biological: human stem cells