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

Leukemia, Nonlymphocytic, Acute Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180167
• Other study ID #: AML_GT60_DD
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: August 19, 2010
• Start date: January 2005
• Est. completion date: July 2010

Study information

• Verified date: August 2010
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Description:

Randomized comparison of the two protocols.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 492
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia, Myeloid, Acute
• Leukemia, Nonlymphocytic, Acute

Intervention

Drug:
• randomization between two established Chemotherapies

Locations

Country	Name	City	State
Germany	Universitätsklinikum	Dresden	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission rate
Primary	Survival
Secondary	toxicity
Secondary	Secondary purpose: Is the prognostic evaluation of the treating physician prior to initiation of chemotherapy (prior to randomization) of predictive value?