Therapy of Acute Myeloid Leukemia in Patients Over the Age of 60 : DA Versus Mitoxantrone With Intermittent AraC
August 19, 2010 updated by: Technische Universität Dresden
Therapy of AML in Patients Older Than 60 Years: Randomized Comparison of a Double Induction With Daunorubicin and AraC (as Continuous Infusion) With a Double Induction With Mitoxantrone and Intermittent, Medium High Dose AraC
Single Arm-Studies suggest improved remission and survival rates for a Protocol with Mitoxantron 10mg/m2 for 3 days combined with AraC 1g/m2 bid on days 1+3+5+7 compared to a conventional DA 7+3 protocol (45mg/m2 Daunorubicin).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Randomized comparison of the two protocols.
Study Type
Interventional
Enrollment (Actual)
492
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sachsen
-
Dresden, Sachsen, Germany, D-1307
- Universitätsklinikum
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of AML
- age >60
- no previous Chemo for AML
- informed consent
- Karnofsky >70
Exclusion Criteria:
- AML M3
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Daunorubicin + Ara-C
|
|
|
Experimental: Mitoxantrone + Ara-C
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Survival
|
|
Complete remission rate
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
toxicity
|
|
Secondary purpose: Is the prognostic evaluation of the treating physician prior to initiation of chemotherapy (prior to randomization) of predictive value?
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ulrich S. Schuler, PD Dr. med., University Hospital Dresden, GERMANY
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
August 20, 2010
Last Update Submitted That Met QC Criteria
August 19, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AML_GT60_DD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.