European Leukemia Trial Registry
Trial: AML Elderly

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Scientific Title Treatment of Elderly Patients (>60 years) with de novo or Secondary Acute Myeloblastic Leukemia or Advanced MDS (RAEB-T): A Study to test the Efficacy of intensive chemotherapy followed by G-CSF and a Feasability Trial of Dose-reduced Allogeneic Transplantation and of Autologous Stem Cell Transplantation
Short Title AML Elderly
Id KN/ELN LN_NN_2000_29
Trialgroup NN
Type of Trial multicentric
Phase Phase III
Disease Myelodysplastic Syndrome(MDS) All subtypes
Acute myeloid leukemia(AML) AML all subtypes without FAB M3
Stage of Disease de novo/non-treated
Category Elderly
Aim
  • To evaluate the efficacy of intensive induction therapy with Ara-C, Idarubicin and VP16 (IdAV) followed by G-CSF in elderly patients with de novo AML, secondary AML and advanced MDS.
  • Comparison of the anti-leukemic efficacy of the IdAV regimen followed by G-CSF in de novo AML versus secondary AML and RAEB-T.
  • Examination of the ability to mobilize sufficient numbers of PBSC for autologous PBSCT after consolidation therapy with dose-reduced FLAG-Ida chemotherapy followed by G-CSF.
  • Investigation of the feasibility of high dose chemotherapy with autologous PBSC support as late consolidation therapy
  • To determine the feasibility of allogeneic transplantation with dose-reduced conditioning („mini- / micro- / metakine transplants“) in elderly patients possessing a histocompatible donor
  • Assessment of minimal residual disease in the course of treatment, including leukemic cell contamination of autologous PBSC grafts.
Inclusion Criteria
  • Diagnosis of de-novo AML, FAB M0, 1, 2, 4-7
  • Diagnosis of secondary AML after previous chemotherapy and/or radiation
  • Diagnosis of an advanced MDS, i.e. RAEB-t according to the FAB classification
  • Extramedullary AML (chloroma, “granulocytic sarcoma”)
  • Age greater than 60 years (not including 60 years)
  • ECOG performance status 0, 1, or 2
  • Written informed consent
Exclusion Criteria
  • Patients with a t(15;17) translocation (these patients will be enrolled in a separate protocol)
  • Patients with severe cardiac disease (e.g. cardiac failure NYHA III/IV, myocardial infarction within the last 6 months; severe ventricular arrythmias (Lown III or IV)
  • Patients with severe complications of the leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock. In the case that these complications are treated successfully, the patient becomes eligible for the study
  • Severe pulmonary disease (diffusion capacity for CO2 of less than 50%)
  • Significant renal dysfunction (creatinine clearance < 60/min/min)
  • Bilirubin > 2mg% (>34.2 mmol/l)
  • Patients with a clinically active second malignancy
  • Patients with a psychiatric, addictive, or any disorder wich compromises ability to give truly informed consent for participating in this study
  • HIV positivity
  • Known refractoriness to platelet transfusion, inability to adequately substitute blood products
Age >= 60 years
Status Closed
Start of Recruitment 05.01.2000
Recruiting Countries Germany
Target Sample Size 250
Leader Ottmann, Prof. Dr., Oliver
Scientific Contact Ottmann, Prof. Dr., Oliver (Affliliation)
Contact Person

Study Physician
Bug, PD Dr. med., Gesine
Tel: +49 (0)69 6301 7369
Fax: +49 (0)69 6301 7463
Email: g.bug@em.uni-frankfurt.de

Study Centre
Zander, Caroline
Tel: +49 (0)69 6301 4802
Fax: +49 (0)69 6301 7463
Email: c.zander@em.uni-frankfurt.de

Centre of Trial Universitätsklinikum Frankfurt
Shortprotocol Shortprotocol
Diagnostics

Cytogenetics
Institut für Humangenetik, Medizinische Hochschule Hannover (MHH)

Other Registers ClinicalTrials.gov NCT00199147 (primary Register)
Outcomes
  • Achievement of complete remission (CR) following one or two induction cycles (Primary Outcome)
  • Overall and disease free survival
  • Early death rate (during induction)
  • Percentage of patients with sufficient mobilization of PBSC
  • Anti-leukemic efficacy, morbidity and mortality of auto-PBSCT
  • Quality of autologous PBSC (Minimal Residual Disease - MRD)
  • Anti-leukemic efficacy, morbidity and mortality of dosereduced allo-PBSCT
created 30.06.2006 Anja Hellenbrecht
changed 28.10.2015 Sina Hehn
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