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.
Phase 3
18 Years
60 Years
18 Years
60 Years
Open (Enrolling)
Both
Acute Myeloid Leukaemia
Both
Acute Myeloid Leukaemia
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Event free survival
Outcome Time Frame:
after 5 years
Safety Issue:
Yes
Principal Investigator
Dietger Niederwieser, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Leipzig Germany
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
AML 2002 #061
NCT ID:
NCT01414231
Start Date:
April 2002
Completion Date:
July 2014
Related Keywords:
- Acute Myeloid Leukaemia
- AML
- acute myeloid leukaemia
- low vs intermediate dose AraC
- CR rate
- patients <60 years
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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