AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years

Leukemia, Nonlymphocytic, Acute Clinical Trial

Official title:

AML2003 - Randomized Comparison Between Standard-Therapy and Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years. A Prospective, Randomized, Multi-center Therapy-Optimizing-Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180102
• Other study ID #: MK1-95
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: December 23, 2009
• Start date: December 2003
• Est. completion date: November 2009

Study information

• Verified date: December 2009
• 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

AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia.

Description:

AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia. A rapid analysis of risk-factors (cytogenetics, FLT3 status, clearance of blasts after first induction) and the donor situation is of utmost importance. For this "fast search" diagnostic, which is accomplished in all enclosed patients, significant resources are provided, to take the load off the participating centers. Furthermore, the relevance of autologous transplantation and the benefit of additional substances within the postremission therapy such as m-AMSA or mitoxantrone will be investigated. There is an up-front randomisation in four therapy arms with two cross-classifying factors of two stages (intensified vs. standard therapy and Ara C vs. Ara C+ mitoxantrone + m-AMSA). Thus, the intergroup treatment schedule of the German Competence Network is integrated into the AML2003 study as a central element and 25% of the patients are treated accordingly. In the intensified therapy arms a risk-adapted and priority-based therapy is implemented, including early allogeneic and consolidating autologous stem cell transplantation, respectively. In addition to the clinical questions , a detailed concomitant research program was initiated for the AML2003 study, to get a better view of the heterogeneity of AML and to open new ways for "custom-made" therapies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• de novo or secondary acute myeloid leukemia FAB-subtypes M0-M2 and M4-M7

• de novo or secondary myelodysplastic syndrome WHO-type RAEB-2

• age 16 to 60 years

• written informed consent

Exclusion Criteria:

• severe comorbidities

• severe, uncontrolled complications of the leukemia

• prior therapy for AML/MDS

• other simultaneous hematological malignancies

• HIV-Infection

• known allergies against study medication

• pregnancy

• missing written informed consent

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Cytarabine vs. Cytarabine+Amsacrine+Mitoxantrone

Procedure:
• early allogeneic PBSCT within induction therapy

• autologous PBSCT

Locations

Country	Name	City	State
Germany	Medical Department I, University Hospital Carl Gustav Carus	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival
Primary	relapse-free survival
Secondary	complete remission rate after induction therapy
Secondary	subgroup-analyses within the primary outcomes according to different risk factors
Secondary	development of explanatory proportional hazard-models