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

Phase 3

Completed

• Conditions: Acute Myeloid Leukaemia
• Interventions: Drug: Cytarabine; Biological: human stem cells

• Registration Number: NCT01497002
• Lead Sponsor: University of Leipzig

Brief Summary

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

Detailed Description

Measuring EFS depending on induction therapy

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2011-12-21
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-22
• Primary Completion: 2018-07-18
• Study Completion: 2018-07-18
• Status Verified: 2022-09
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1222

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OSHO - intensified consolidation	Cytarabine	Intermediate dose AraC
OSHO - allografting as consolidation	human stem cells	allogeneic stem cell Transplantation versus no transplantation
standard arm	Cytarabine	standard treatment arm

Primary Outcome Measures

Name	Time	Method
Event free survival	after 5 years	comparison of event free survival (OSHO arm versus Standard intergroup arm)

Secondary Outcome Measures

Name	Time	Method
LFS	at 5 years	leukemia free survival
OS	at 5 years	Overall survival

Trial Locations

Locations (1)

University of Leipzig, Hematology; 🇩🇪 Leipzig, Germany