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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01414231 |
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Date of registration:
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05/08/2011 |
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Primary sponsor: |
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Public title:
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Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML<60a
OSHO#061 |
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Scientific title:
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Randomised Comparison of OSHO Induction vs. the German AML Intergroup Standard, Randomised Comparison of AraC/Mtx vs. Flu/AraC/Mtx in Pts Without CR After One Induction Cycle and Randomized Comparison of One vs. Two Consolidation Therapies. |
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Date of first enrolment:
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April 2002 |
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Target sample size:
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850 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01414231 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Dietger Niederwieser |
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Address:
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Telephone:
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+4934197 |
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Email:
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dietger@medizin.uni-leipzig.de |
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Affiliation:
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Name:
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Dietger Niederwieser, Prof. |
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Address:
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Telephone:
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+49 172 3436202 |
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Email:
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dietger@medizin.uni-leipzig.de |
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Affiliation:
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Name:
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Dietger Niederwieser, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Leipzig Germany |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
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 Criteria:
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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Myeloid Leukaemia
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Intervention(s)
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Drug: Cytarabine
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Primary Outcome(s)
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Event free survival
[Time Frame: after 5 years]
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Secondary Outcome(s)
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Complete remission
[Time Frame: average of 6 weeks]
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Overall survival
[Time Frame: at 5 years average]
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Relapse free survival
[Time Frame: at 5 years average]
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Secondary ID(s)
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AML 2002 #061
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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