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

Phase 2

• Conditions: De Novo Akute Myeloid Leukemia (AML); Secondary Acute Myeloid Leukemia (AML); Refractory Anemia With Excess of Blasts in Transformation

• Registration Number: NCT00209833
• Lead Sponsor: Hannover Medical School

Brief 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.

Detailed 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

Study Timeline

• Study Start: 1999-01
• Status Verified: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Last Update Submitted: 2005-11-17
• Last Update Posted: 2005-11-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy and toxicity of FLAG-Ida as second induction course in high risk patients.
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 Outcome Measures

Name	Time	Method
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 minimal residual disease.

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Germany