Therapy of Acute Myeloid Leukemia in Patients Over the Age of 60 : DA Versus Mitoxantrone With Intermittent AraC

This study is currently recruiting participants.

Verified by Dresden University of Technology, March 2007

Sponsored by:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00180167

Purpose

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).

Condition	Intervention	Phase
Leukemia, Nonlymphocytic, Acute	Drug: daunorubicin Drug: AraC Drug: mitoxantrone	Phase IV

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cytarabine Cytarabine hydrochloride Daunorubicin hydrochloride Daunorubicin Mitoxantrone hydrochloride Mitoxantrone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

Complete remission rate
Survival

Secondary Outcome Measures:

toxicity
(Secondary purpose: Is the prognostic evaluation of the treating physician
prior to initiation of chemotherapy (prior to randomziation)
of predictive value? )

Estimated Enrollment:	260
Study Start Date:	January 2005
Estimated Study Completion Date:	January 2010

Detailed Description:

Randomized comparison of the two protocols.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180167

Contacts

Contact: Ulrich S Schuler, PD Dr.med.	49 351 458 ext 4670	ulrich.schuler@uniklinikum-dresden.de
Contact: Gerhard Ehninger, Prof.Dr.med.	49 351 458 ext 4190	gerhard.ehninger@uniklinikum-dresden.de

Locations

Germany, Sachsen
Universitätsklinikum	Recruiting
Dresden, Sachsen, Germany, D-1307
Contact: Ulrich S Schuler, PD Dr. med. 49351 458 4670 ulrich.schuler@uniklinikum-dresden.de
Principal Investigator: ulrich S Schuler, PD Dr. med.
Sub-Investigator: Markus Schaich, PD Dr. med.

Sponsors and Collaborators

Dresden University of Technology

Investigators

Principal Investigator:

Ulrich S. Schuler, PD Dr. med.

University Hospital Dresden, Germany

More Information

Publications:

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.

Study ID Numbers:	AML_GT60_DD
Study First Received:	September 13, 2005
Last Updated:	April 4, 2007
ClinicalTrials.gov Identifier:	NCT00180167
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

Chemotherapy
elderly

Study placed in the following topic categories:

Daunorubicin
Leukemia
Acute myelogenous leukemia
Mitoxantrone

Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009