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

• Sponsor: Technische Universität Dresden (Other)
• Overall Status: Completed
• CT.gov ID: NCT00180167
• Collaborator: (none)
• Enrollment: 492
• Location: 1
• Arms: 2
• Duration (Months): 65.9
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Leukemia, Nonlymphocytic, Acute	Drug: randomization between two established Chemotherapies	Phase 4

Detailed Description

Randomized comparison of the two protocols.

Study Design

• Study Type: Interventional
• Actual Enrollment: 492 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Daunorubicin + Ara-C	Drug: randomization between two established Chemotherapies
Experimental: Mitoxantrone + Ara-C	Drug: randomization between two established Chemotherapies

Outcome Measures

Primary Outcome Measures

1. Complete remission rate []

2. Survival []

Secondary Outcome Measures

1. toxicity []

2. Secondary purpose: Is the prognostic evaluation of the treating physician prior to initiation of chemotherapy (prior to randomization) of predictive value? []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum	Dresden	Sachsen	Germany	D-1307

Sponsors and Collaborators

• Technische Universität Dresden

Investigators

• Principal Investigator: Ulrich S. Schuler, PD Dr. med., University Hospital Dresden, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

• Mantovani L, Hasenclever D, Krahl R, Pönisch W, Herold M, Pasold R, Fiedler F, Dölken G, Kämpfe D, Schmoll HJ, Súbert 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.

• ClinicalTrials.gov Identifier: NCT00180167
• Other Study ID Numbers: AML_GT60_DD
• First Posted: Sep 16, 2005
• Last Update Posted: Aug 20, 2010
• Last Verified: Aug 1, 2010

• Keywords provided by , ,: Chemotherapy; elderly
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Aug 20, 2010