Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a
NCT ID: NCT01497002
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1222 participants
INTERVENTIONAL
2005-04-30
2018-07-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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standard arm
standard treatment arm
Cytarabine
Induction chemotherapy (1 or 2 courses): AraC 100 mg/m²/day i.v. 24h-infusion day 1-7 and Daunorubicin 60 mg/m² day 3+4+5. Consolidation chemotherapy (2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5.
OSHO - intensified consolidation
Intermediate dose AraC
Cytarabine
Induction chemotherapy (1 or 2 courses): AraC 100 mg/m²/day i.v. 24h-infusion day 1-7 and Daunorubicin 60 mg/m² day 3+4+5. Consolidation chemotherapy (2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5.
OSHO - allografting as consolidation
allogeneic stem cell Transplantation versus no transplantation
human stem cells
Induction chemotherapy (1 or 2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5+7, Mitoxantrone 10 mg/m² day 1-3 and Pegfilgrastim 6 mg s.c. day 10. Consolidation chemotherapy (1 course): AraC 500 mg/m² i.v. 1h-infusion a 12h day 1+3+5, Mitoxantrone 10 mg/m² day 1+2 and Pegfilgrastim 6 mg s.c. day 8. Allogeneic stem cell transplantation using reduced intensity conditioning: Fludarabine 30 mg/m² day -4 - -2, TBI 200 cGy day 0; GvHD prophylaxis: cyclosporine A and mofetil mycofenolate
Interventions
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Cytarabine
Induction chemotherapy (1 or 2 courses): AraC 100 mg/m²/day i.v. 24h-infusion day 1-7 and Daunorubicin 60 mg/m² day 3+4+5. Consolidation chemotherapy (2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5.
human stem cells
Induction chemotherapy (1 or 2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5+7, Mitoxantrone 10 mg/m² day 1-3 and Pegfilgrastim 6 mg s.c. day 10. Consolidation chemotherapy (1 course): AraC 500 mg/m² i.v. 1h-infusion a 12h day 1+3+5, Mitoxantrone 10 mg/m² day 1+2 and Pegfilgrastim 6 mg s.c. day 8. Allogeneic stem cell transplantation using reduced intensity conditioning: Fludarabine 30 mg/m² day -4 - -2, TBI 200 cGy day 0; GvHD prophylaxis: cyclosporine A and mofetil mycofenolate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* written informed consent
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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University of Leipzig
OTHER
Responsible Party
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Principal Investigators
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Dietger Niederwieser, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Leipzig
Locations
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University of Leipzig, Hematology
Leipzig, , Germany
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Related Links
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AML 2004 OSHO #069 (Elderly)
Other Identifiers
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OSHO#069
Identifier Type: -
Identifier Source: org_study_id
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