Status:
UNKNOWN
Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML<60a
Lead Sponsor:
University of Leipzig
Conditions:
Acute Myeloid Leukaemia
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
This protocol is part of the German AML Intergroup Trial, where the OSHO study arm is compared to the common German standard arm after randomization in a 9:1 ratio. The hypothesis involves primarily d...
Eligibility Criteria
Inclusion
- Adult patients \< or = 60 years acute myelogenous leukemia (AML) AML t(8;21)(q22;q22), AML1 (CBFa)/ETO, AML(inv(16)(p13q22)) und variants (CBFb/MYH11), AML 11q23, MLL-anomalies, AML with normal karyotyp myelodysplastic syndrome (MDS)RAEBT with 20-30% blasts.
- de novo AML secundary AML after MDS secundary AML after chemotherapy with alkylantien sekundäre AML after chemotherapy with Epipodophyllotoxin informed consent
Exclusion
- AML M3 patients included in another clinical trial contraindications for high dose cytotoxic therapy such as renal insufficiency liver insufficiency cardiac insufficiency NYHA III + IV, acute myocardial infarction uncontroled infection like pneumonia with hypoxemia or septic schock pregnancy Karnofski-Index of 10 and less second maligancy severe, decompensated metabolism disorders
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2014
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT01414231
Start Date
April 1 2002
End Date
July 1 2014
Last Update
August 11 2011
Active Locations (1)
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1
University of Leipzig, Hematology
Leipzig, Germany, 04103