Treatment of Adults Aged Up to 60 Years With De Novo Acute Myeloblastic Leukaemia,Secondary AML, or RAEB-T

Secondary Acute Myeloid Leukemia (AML) Clinical Trial

Official title:

Protocol for the Treatment of Adults Aged </= 60 Years With De Novo Acute Myeloblastic Leukaemia or Secondary AML or RAEB-T (AML 01/99 Trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00209833
• Other study ID #: AML 01/99 trial
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: November 17, 2005
• Start date: January 1999
• Est. completion date: September 2005

Study information

• Verified date: September 2005
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This randomized phase II/III trial investigates the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with acute myeloid leukaemia and bad response to the first induction cycle and/or with a high risk karyotype and compares the antileukemic activity and toxicity of high dose cytarabine/daunorubicin vs. autologous peripheral blood stem cell transplantation as late consolidation therapy in standard risk patients.

Description:

Assessment of the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with bad response to the first induction cycle and/or with a high risk karyotype.

Optimization of the late consolidation therapy in standard risk patients (SR) by a prospective randomized trial comparing a high-dose cytarabine/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy with an autologous peripheral blood stem cell transplantation (PBSCT)

Assessment of the antileukemic activity of the different treatment elements by monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR

Assessment of the prognostic relevance of minimal residual disease by quantification of the residual leukemic burden in haematological remission by Real-time PCR during follow-up

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• diagnosis of de-novo AML, FAB M 1, 2, 4 - 7

• diagnosis of secondary AML after chemo-/radiotherapy or MDS

• diagnosis of RAEB-T

• age between 16 and 60 years (including 60 years)

• women after exclusion of pregnancy

• written informed consent

Exclusion Criteria:

• patients with severe disease of the heart (e.g. cardial failure NYHA III/IV; history of myocardial infarction within the last 6 months;severe ventricular arrythmias (Lown III to IV)

• patients with DLCO < 50%

• patients with creatinine clearance < 60 ml/min

• patients with bilirubin > 2mg% (34.2 mmol/L)

• patients with severe complications of the leukaemia such as uncontrolled bleeding, pneumonia with hypoxia or shock

• patients with a psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participating in this study

• HIV positivity

• patients with a t(15;17) translocation

Study Design

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

Related Conditions & MeSH terms

• Anemia, Refractory, with Excess of Blasts
• De Novo Akute Myeloid Leukemia (AML)
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Neoplasm Metastasis
• Refractory Anemia With Excess of Blasts in Transformation
• Secondary Acute Myeloid Leukemia (AML)

Intervention

Drug:
• Cytarabine

• Idarubicin

• Etoposide

• Fludarabine

• G-CSF

• Daunorubicine

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (12)

Lead Sponsor	Collaborator
Hannover Medical School	Ev. Krankenhaus Essen-Werden, Humboldt-Universität zu Berlin, Johann Wolfgang Goethe University Hospitals, Klinikum Augsburg, Klinikum Hanover-Siloah Hospital, Klinikum Wuppertal GmbH, Medizinische Universitätsklinik Tübingen, Universitätsklinikum Hamburg-Eppendorf, University Hospital Freiburg, University Hospital, Ghent, University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy and toxicity of FLAG-Ida as second induction course in high risk patients.
Primary	Efficacy and toxicity of high-dose cytarabin/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy vs. autologous peripheral blood stem cell transplantation in standard risk patients.
Secondary	Monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR.
Secondary	Assessment of the prognostic relevance of minimal residual disease by quantification of minimal residual disease.

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