Overview

This trial is active, not recruiting.

Conditions de novo akute myeloid leukemia (aml), secondary acute myeloid leukemia (aml), refractory anemia with excess of blasts in transformation
Treatments cytarabine, idarubicin, etoposide, fludarabine, g-csf, daunorubicine
Phase phase 2/phase 3
Sponsor Hannover Medical School
Collaborator University of Ulm
Start date January 1999
End date September 2005
Trial size 200 participants
Trial identifier NCT00209833, AML 01/99 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Efficacy and toxicity of FLAG-Ida as second induction course in high risk patients.
time frame:
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.
time frame:

Secondary Outcomes

Measure
Monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR.
time frame:
Assessment of the prognostic relevance of minimal residual disease by quantification of minimal residual disease.
time frame:

Eligibility Criteria

Male or female participants from 16 years up to 60 years old.

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

Additional Information

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)
Principal investigator Arnold Ganser, Prof. Dr.
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
Trial information was received from ClinicalTrials.gov and was last updated in November 2005.
Information provided to ClinicalTrials.gov by Hannover Medical School.