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Protocol for the Treatment of Adults Aged

Phase 2/Phase 3
16 Years
60 Years
Open (Enrolling)
De Novo Akute Myeloid Leukemia (AML), Secondary Acute Myeloid Leukemia (AML), Refractory Anemia With Excess of Blasts in Transformation

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Trial Information

Protocol for the Treatment of Adults Aged

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

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

Type of Study:


Study Design:

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

Outcome Measure:

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

Principal Investigator

Arnold Ganser, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hannover Medical School


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AML 01/99 trial



Start Date:

January 1999

Completion Date:

September 2005

Related Keywords:

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