European Leukemia Trial Registry
Trial: ALL GMALL 07/2003

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Public Title Therapy optimization by MRD-evaluation
Scientific Title Multicenter Study To Optimize Treatment of Acute Lymphoblastic Leukemia in Adults (> 18 years)- Treatment Optimization by Evaluation of Minimal Residual Disease
Short Title ALL GMALL 07/2003
Id KN/ELN LN_GMALLE_2003_4
Trialgroup GMALL
Type of Trial multicentric
Phase Phase IV
Disease Acute lymphoblastic leukemia(ALL) All subtypes
Stage of Disease de novo/non-treated
Aim
  • Improvement of remission duration and survival
  • Prospective evaluation of minimal residual disease (MRD)
  • Evaluation of feasibility and efficacy of new treatment elements
Inclusion Criteria
  • Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, thymic T, mature T)
  • Age 18-65 yrs (*55-65 years if biologically younger according to general condition)
  • Written informed consent
Exclusion Criteria
  • Severe comorbidity or leukemia associated complications
  • Late relapse of pediatric ALL or ALL as second malignancy
  • Cytostatic pre-treatment
  • Pregnancy
  • Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
  • Participation in other clinical trials interfering with the study therapy
Age <= 65 years (55-65 years if biologically younger)
Status No longer recruiting
Start of Recruitment 01.04.2003
Recruiting Countries Germany
Target Sample Size 1600
Leader Gökbuget, Dr. med., Nicola
Scientific Contact Gökbuget, Dr. med., Nicola (GMALL-Study Group, University Clinic of Frankfurt/Germany)
Contact Person

Study Physician
Gökbuget, Dr. med., Nicola
Tel: +49 (0)69 6301-6366
Fax: +49 (0)69 6301- 7463
Email: goekbuget@em.uni-frankfurt.de

Study Centre
Reutzel, Regina
Tel: +49 (0)69 6301-6366
Fax: +49 (0)69 6301-7463
Email: reutzel@em.uni-frankfurt.de

Biometrics
Messerer, Dr. rer. nat., Dorle
Tel: +49 (0)911 630479
Fax: +49 (0)911 639127
Email: dorle@messerer.com

Centre of Trial Universitätsklinikum Frankfurt
Shortprotocol Shortprotocol
Diagnostics

Molecular Genetics
Hämatologie Labor Kiel, Klinik für Innere Medizin II, UKSH, Kiel
Molekulargenetik-Labor der Med.Klinik II, Universitätsklinikum Frankfurt

Immunophaenotyping
Immunologisches Markerlabor der Charité Berlin, Campus Benjamin-Franklin

Cytogenetics
Tumorzytogenetik-Labor, Universität Düsseldorf

Qualitymark German Cancer Organization
Supporters Deutsche Krebshilfe e.V.
Other Registers ClinicalTrials.gov NCT00198991 (primary Register)
Interventions
  • Cyclophosphamid
  • Dexamethason
  • Vincristin
  • Daunorubicin
  • Asparaginase
  • Methotrexat
  • Cytarabine
  • Mercaptopurin
  • G-CSF
  • Vindesine
  • VP16
  • Prednisolon
  • Adriamycin
  • Thioguanin
  • VM26
  • CNS-Irradiation
Remark Amendment I from 18. August 2004; Amendment II from 12. September 2006 Amendment III from 17. December 2007; Amendment IV from 29. December 2008 Amendment from 20. August 2009; Amendment 6 from 30.June 2010
created 31.05.2006 Anja Hellenbrecht
changed 18.07.2017 Eva-Maria Ableidinger
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