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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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)

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 Summary:

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


Sponsor: Hannover Medical School

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Hannover Medical School

Dates:
Date Received: September 13, 2005
Date Started: January 1999
Date Completion: September 2005
Last Updated: November 17, 2005
Last Verified: September 2005