European Leukemia Trial Registry
Trial: HD-Melphalan

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Public Title High-dose melphalan and autologous SCT in relapsed AML
Scientific Title High-dose melphalan with autologous stem cell transplantation in patients with relapsed acute myeloid leukemia (AML)
Short Title HD-Melphalan
Id KN/ELN LN_NN_2004_72
Trialgroup NN
Type of Trial multicentric
Phase Phase II
Disease Acute myeloid leukemia(AML) AML all subtypes without FAB M3
Stage of Disease relapsed/refractory
Category stem cell transplantation
Aim
  • Evaluation of safety and tolerance of high-dose melphalane and autologous stem cell transplantation in relapsed AML-patients concerning hematological and non-hematological toxicity
  • Evaluation of efficiency of therapy with high-dose melphalan and autologous stem cell transplantation on the basis of remission rate of relapsed AML
  • Evaluation of efficiency of therapy with high-dose melphalan and autologous stem cell transplantation concerning event-free survival, time of remission and overall survival of the patient groups
Inclusion Criteria
  • Relapse of AML after chemotherapy or autologous stem cell transplantation
  • presence of a autologous graft, fetched during complete remission
  • Duration of complete remission > 2 month
  • age > 18 years
  • patients general condition < 2 according to ECOG performance scale
  • confirmed contraception in fertile female patients
  • written informed consent
Exclusion Criteria
  • severe concomittant diseases (clinically relevant heart failure, coronary sclerosis, chronic-obstructive lung disease, liver-, or kidney-dysfunction,
  • active secondary malignancies (except: adaequately treated basalcell-carcinoma or squamous cell carcinoma of the skin and carcinoma in-situ of the cervix)
  • general condition > 2 according to ECOG performance scale
  • Pregnant or breastfeeding women
  • no informed consent
Age >= 18 years
Status No longer recruiting
Start of Recruitment 05.04.2004
Recruiting Countries Germany
Target Sample Size 20
Leader Martin, PD Dr. med., Hans
Scientific Contact Martin, PD Dr. med., Hans (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

Centre of Trial Universitätsklinikum Frankfurt
Shortprotocol Shortprotocol
Sponsors Martin, PD Dr. med., Hans (Main Sponsor)
Outcomes
  • event-free survival
  • time of remission
  • overall survival (Primary Outcome)
Interventions
  • melphalan
  • autologous stem cell transplantation
created 10.07.2006 Anja Hellenbrecht
changed 19.01.2015 Hanna Ebert
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