European Leukemia Trial Registry
Trial: ALL GMALL Allo-SCT-Treo-VP16-Cyclo in ALL

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Public Title Allogeneic Stem Cell Transplantation with Treosulfan, VP-16 and Cyclophosphamide for patients with ALL
Scientific Title Allogeneic Stem Cell Transplantation with Treosulfan, VP-16 and Cyclophosphamide for patients with Acute Lymphoblastic Leukemia (ALL) not eligible for TBI-containing regimen: A phase II study
Short Title ALL GMALL Allo-SCT-Treo-VP16-Cyclo in ALL
Id KN/ELN LN_GMALL_2007_278
Trialgroup GMALL
Type of Trial multicentric
Phase Phase II
Disease Acute lymphoblastic leukemia(ALL) Stem cell transplantation
Stem cell transplantation(SCT) ALL
Stage of Disease .
Category stem cell transplantation
Aim
  • The present study will be a multicenter, prospective phase II-study investigating safety and efficacy of the combination of treosulfan, etoposide, and cyclophosphamid as conditioning regimen for patients with acute lymphoblastic leukemia who are not eligible for a TBI-containing regimen
Inclusion Criteria
  • Acute lymphoblastic leukemia in first or subsequent remission
  • Indication for allogeneic stem cell transplantation acc. To the actual protocol of the German Acute Lymphoblastic Leukemia Study Group
  • Patient’s age: 18-65 years
  • HLA-identical or compatible related or unrelated donor
  • Not eligible for total body irradiation
  • Patient’s written informed consent
  • Adequate contraception
Exclusion Criteria
  • No complete remission at time of registration
  • Severe irreversible renal, hepatic, pulmonary or cardiac disease
  • Positive serology for HIV
  • Pregnant or lactating women
  • Severe florid infection
  • Experienced Hypersensitivity against the study drug
  • Cystitis
  • obstructive renal function
  • Participation in any other clinical drug trial
  • Serious psychiatric or psychological disorders
  • Progressive invasive fungal infection at time of registration
Age <= 65 years
Status Closed
Start of Recruitment 06.07.2007
Recruiting Countries Germany
Target Sample Size 55
Leader Kröger, Prof. Dr. med., Nicolaus
Scientific Contact Kröger, Prof. Dr. med., Nicolaus (Affliliation)
Contact Person

principal investigator
Kröger, Prof. Dr. med., Nicolaus
Tel: +49 (0)40 42803 5864
Fax: +49 (0)40 42803 3795
Email: nkroeger@uke.uni-hamburg.de

principal investigator
Beelen, Prof. Dr., Dietrich W.

Study Centre
Heinzelmann, Marion

Shortprotocol Shortprotocol
Sponsors Universitätsklinikum Eppendorf
Other Registers ClinicalTrials.gov NCT00682305 (primary Register)
European Clinical Trials Database - EUDRACT 2006-003566-34
Outcomes
  • Evaluation of engraftment day 28 and non-relapse mortality at day 100 and at 1 year after allogeneic stem cell transplantation (Primary Outcome)
  • Incidence of aGvHD day 100 acc. Glucksberg scale
  • Incidence of cGvHD accSeattle criteria
  • Toxicity acc. NCI-CTCAE V3.0
  • Cumulative Incidence of relapse 2 years
  • DFS 2 years
  • OS 2 years
Interventions
  • Treosulfan: according to protocol
  • Etoposide: according to protocol
  • Cyclophoshamide: according to protocol
Therapy On day -7 to -5 Treosulfan is given in a dosage of 12 g/m² followed by Etoposide on day -4 in a dosage of 30 mg/kg BW and Cyclophophamide on day -3 and -2 at a dosage of 60 mg/kg BW
created 29.07.2008 5 Roswitha Kotthoff
changed 21.01.2016 Zenawit Krüger
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