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Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Treatment Active Over 60 Other AML-elderly 01/99 Trial NCT00199147

Trial Description

Summary

Aim of the study is to compare the efficacy of intensive induction therapy with Cytarabine, Idarubicin and Etoposide (IdAV) given in parallel with (G-CSF priming) and followed by G-CSF versus the same IdAV chemotherapy only followed by G-CSF (without priming) in elderly patients with de novo AML, secondary AML and advanced MDS. Moreover, the ability to mobilize sufficient numbers of peripheral blood stem cells (PBSC) for autologous PBSC transplantation after consolidation therapy with dose-reduced FLAG-Ida chemotherapy followed by G-CSF will be evaluated.

Eligibility Criteria

Inclusion Criteria:

• Diagnosis of de-novo AML, FAB M0, 1, 2, 4-7 or

• Diagnosis of secondary AML after previous chemotherapy and/or radiation therapy or after preceeding MDS or

• Diagnosis of an advanced MDS, i.e. RAEB-t according to the FAB classification or

• 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

• 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.

• 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Klinikum der J.W. Goethe Universitaet

Oliver G Ottmann, MD

Study Chair

Germany
	Frankfurt
	Universitaetsfrauenklinik Frankfurt
		Oliver G Ottmann, MD	Ph: ++49-69-6301-4802
			Email: ottmann@em.uni-frankfurt.de
		Gesine Bug, MD	Ph: ++49-69-6301-4802
			Email: g.bug@em.uni-frankfurt.de
		Oliver G Ottmann, MD	Principal Investigator
		Gesine Bug, MD	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00199147
Information obtained from ClinicalTrials.gov on September 15, 2008