Therapy of Acute Myeloid Leukemia in Patients Over the Age of 60 : DA Versus Mitoxantrone With Intermittent AraC
NCT ID: NCT00180167
Last Updated: 2010-08-20
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
PHASE4
492 participants
INTERVENTIONAL
2005-01-31
2010-07-31
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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Daunorubicin + Ara-C
randomization between two established Chemotherapies
Mitoxantrone + Ara-C
randomization between two established Chemotherapies
Interventions
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randomization between two established Chemotherapies
Eligibility Criteria
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Inclusion Criteria
* age \>60
* no previous Chemo for AML
* informed consent
* Karnofsky \>70
Exclusion Criteria
* uncontrolled Sepsis
* uncontrolled HYpertension
* respiratory failure
* heart-failure NYHA IV, recent myocardial infarction
* severe organ dysfunction of liver, kidneys,
* HIV -infection or active Hepatitis B,C
60 Years
ALL
No
Sponsors
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Technische Universität Dresden
OTHER
Principal Investigators
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Ulrich S. Schuler, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Dresden, Germany
Locations
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Universitätsklinikum
Dresden, Saxony, Germany
Countries
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References
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Mantovani L, Hasenclever D, Krahl R, Ponisch W, Herold M, Pasold R, Fiedler F, Dolken G, Kampfe D, Schmoll HJ, Subert R, Kubel M, Niederwieser D, Helbig W; East German Hematology and Oncology Group (OSHO). Intermediate-dose cytarabine treatment delivered at moderate infusion rates for de novo acute myeloid leukemia-results of a phase I-II study. Leuk Lymphoma. 2002 Feb;43(2):265-74. doi: 10.1080/10428190290006035.
Kunadt D, Stasik S, Metzeler KH, Rollig C, Schliemann C, Greif PA, Spiekermann K, Rothenberg-Thurley M, Krug U, Braess J, Kramer A, Hochhaus A, Scholl S, Hilgendorf I, Brummendorf TH, Jost E, Steffen B, Bug G, Einsele H, Gorlich D, Sauerland C, Schafer-Eckart K, Krause SW, Hanel M, Hanoun M, Kaufmann M, Wormann B, Kramer M, Sockel K, Egger-Heidrich K, Herold T, Ehninger G, Burchert A, Platzbecker U, Berdel WE, Muller-Tidow C, Hiddemann W, Serve H, Stelljes M, Baldus CD, Neubauer A, Schetelig J, Thiede C, Bornhauser M, Middeke JM, Stolzel F; A. M. L. Cooperative Group (AMLCG), Study Alliance Leukemia (SAL). Impact of IDH1 and IDH2 mutational subgroups in AML patients after allogeneic stem cell transplantation. J Hematol Oncol. 2022 Sep 5;15(1):126. doi: 10.1186/s13045-022-01339-8.
Other Identifiers
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AML_GT60_DD
Identifier Type: -
Identifier Source: org_study_id
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