GMALL Registry and Collection of Biomaterial: Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult Acute Lymphoblastic Leukemia (ALL) Patients and Related Diseases Associated With a Prospective Collection of Biomaterial (GMALLregistry)
Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult ALL Patients and Related Diseases Associated With a Prospective Collection of Biomaterial
Study Overview
Status
Status
Conditions
Conditions
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Nicola Gökbuget, Dr. med.
- Phone Number: +496963016365
- Email: goekbuget@em.uni-frankfurt.de
Study Contact Backup
- Name: GMALL Study center
- Email: gmall@em.uni-frankfurt.de
Study Locations
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Graz, Austria
- Recruiting
- Universitätsklinikum Graz
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Leoben, Austria
- Recruiting
- LKH-Hochsteiermark Leoben
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Linz, Austria
- Recruiting
- Ordensklinikum Linz Elisabethinen
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Sankt Pölten, Austria
- Recruiting
- Universitätsklinikum St. Pölten
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Vienna, Austria
- Recruiting
- Hanusch-Krankenhaus Wien
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Aachen, Germany
- Recruiting
- Universitätsklinikum Aachen
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Altenburg, Germany
- Recruiting
- Klinikum Altenburger Land
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Altötting, Germany
- Recruiting
- Kreiskliniken Altötting
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Aschaffenburg, Germany
- Recruiting
- Klinikum Aschaffenburg
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Augsburg, Germany
- Recruiting
- Klinikum Augsburg
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Bad Saarow, Germany
- Recruiting
- HELIOS Klinikum Bad Saarow
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Bamberg, Germany
- Recruiting
- Sozialstiftung Bamberg
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Bayreuth, Germany
- Recruiting
- Klinikum Bayreuth
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Berlin, Germany
- Recruiting
- Charité Universitätsmedizin Berlin
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Berlin, Germany
- Recruiting
- Helios Klinikum Berlin-Buch
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Berlin, Germany
- Recruiting
- Vivantes Klinikum Neukölln
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Berlin, Germany
- Recruiting
- Evangelisches Waldkrankenhaus Spandau
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Berlin, Germany
- Recruiting
- Vivantes-Klinikum am Urban
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Bielefeld, Germany
- Recruiting
- Klinikum Bielefeld
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Bielefeld, Germany
- Recruiting
- Evangelisches Krankenhaus Bielefeld
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Bochum, Germany
- Recruiting
- Universitätsklinikum Knappschaftskrankenhaus Bochum
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Bochum, Germany
- Recruiting
- Katholisches Klinikum Bochum
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Bochum, Germany
- Recruiting
- Augsuta Krankenanstalt Bochum
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Bonn, Germany
- Recruiting
- Universitatsklinikum Bonn
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Bonn, Germany
- Recruiting
- Johanniter-Krankenhaus Bonn
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Braunschweig, Germany
- Recruiting
- Städtisches Klinikum Braunschweig
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Bremen, Germany
- Recruiting
- Klinikum Bremen-Mitte gGmbH
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Bremen, Germany
- Recruiting
- Evangelische Diakonissenanstalt Bremen
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Chemnitz, Germany
- Recruiting
- Klinikum Chemnitz gGmbH
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Cologne, Germany
- Recruiting
- Universitätsklinikum Köln
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Cottbus, Germany
- Recruiting
- Carl-Thiem-Klinikum Cottbus
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Darmstadt, Germany
- Recruiting
- Klinikum Darmstadt
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Dessau, Germany
- Recruiting
- Städtisches Krankenhaus Dessau
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Dortmund, Germany
- Recruiting
- Klinikum Dortmund
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Dortmund, Germany
- Recruiting
- St. Johannes-Hospital Dortmund
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Dresden, Germany
- Recruiting
- Städtisches Klinikum Dresden
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Dresden, Germany
- Recruiting
- Klinikum Carl-Gustav-Carus
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Duisburg, Germany
- Recruiting
- Helios Klinikum Duisburg
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Duisburg, Germany
- Recruiting
- Johanniter-Krankenhaus Duisburg
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Düren, Germany
- Recruiting
- Krankenhaus Düren
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Düsseldorf, Germany
- Recruiting
- Universitätsklinikum Düsseldorf
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Düsseldorf, Germany
- Recruiting
- Marien-Hospital Düsseldorf
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Erfurt, Germany
- Recruiting
- Helios Klinikum Erfurt
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Erlangen, Germany
- Recruiting
- Universitätsklinikum Erlangen
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Eschweiler, Germany
- Recruiting
- St.-Antonius-Hospital Eschweiler
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Essen, Germany
- Recruiting
- Universitätsklinikum Essen
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Essen, Germany
- Recruiting
- Evang. Krankenhaus Essen-Werden
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Flensburg, Germany
- Recruiting
- Malteser Krankenhaus Flensburg
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Frankfurt, Germany
- Recruiting
- Klinikum Frankfurt-Oder
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Frankfurt, Germany
- Recruiting
- Städt. Klinikum Frankfurt-Höchst
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Freiburg im Breisgau, Germany
- Recruiting
- Universitatsklinikum Freiburg
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Fulda, Germany
- Recruiting
- Klinikum Fulda
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Georgsmarienhütte, Germany
- Recruiting
- Niels-Stensen-Kliniken Georgsmarienhütte
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Giessen, Germany
- Recruiting
- Klinik der Justus-Liebig-Universität Gießen
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Goch, Germany
- Recruiting
- Wilhelm-Anton-Hospital Goch
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Greifswald, Germany
- Recruiting
- Universitätsklinikum Ernst-Moritz-Arndt-Universität
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Göttingen, Germany
- Recruiting
- Universitätsklinikum Göttingen
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Gütersloh, Germany
- Recruiting
- Städtisches Krankenhaus Gütersloh
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Hagen, Germany
- Recruiting
- Katholisches Krankenhaus Hagen gGmbH
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Halle, Germany
- Recruiting
- Krankenhaus St. Elisabeth und St. Barbara Halle/Saale
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Halle, Germany
- Recruiting
- Martin-Luther-Universität Halle-Wittenberg
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Hamburg, Germany
- Recruiting
- Universitätsklinikum Hamburg-Eppendorf
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Hamburg, Germany
- Recruiting
- Asklepios Klinik Altona Hamburg
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Hamburg, Germany
- Recruiting
- Asklepios Klinik St. Georg Hamburg
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Hamm, Germany
- Recruiting
- Evangelisches Krankenhaus Hamm gGmbH
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Hamm, Germany
- Recruiting
- St. Barbara-Klinik Hamm
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Hanover, Germany
- Recruiting
- Medizinische Hochschule Hannover
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Hanover, Germany
- Recruiting
- Klinikum Siloah Hannover
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Heidelberg, Germany
- Recruiting
- Universitatsklinikum Heidelberg
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Heilbronn, Germany
- Recruiting
- SLK Kliniken Heilbronn
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Herne, Germany
- Recruiting
- Marienhospital Herne
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Hildesheim, Germany
- Recruiting
- St. Bernward Krankenhaus Hildesheim
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Homburg/Saar, Germany
- Recruiting
- Universitatsklinikum des Saarlandes
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Idar-Oberstein, Germany
- Recruiting
- Klinikum Idar-Oberstein
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Jena, Germany
- Recruiting
- Universitatsklinikum Jena
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Karlsruhe, Germany
- Recruiting
- Städt. Klinikum Karlsruhe
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Karlsruhe, Germany
- Recruiting
- St. Vincentius-Kliniken Karlsruhe
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Kassel, Germany
- Recruiting
- Klinikum Kassel Gmbh
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Kiel, Germany
- Recruiting
- Universitatsklinikum Schleswig-Holstein
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Kiel, Germany
- Recruiting
- Stadtisches Krankenhaus Kiel
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Koblenz, Germany
- Recruiting
- Gemeinschaftsklinikum Mittelrhein Koblenz
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Krefeld, Germany
- Recruiting
- Helios Klinikum Krefeld
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Kulmbach, Germany
- Recruiting
- Klinikum Kulmbach
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Landshut, Germany
- Recruiting
- Klinikum Landshut
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Leipzig, Germany
- Recruiting
- Universitatsklinikum Leipzig
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Lippe, Germany
- Recruiting
- Klinikum Lippe-Lemgo
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Ludwigshafen, Germany
- Recruiting
- Klinikum der Stadt Ludwigshafen
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Lübeck, Germany
- Recruiting
- Universitätsklinikum Schleswig-Holstein - Campus Lübeck
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Lübeck, Germany
- Recruiting
- Sana Kliniken Lubeck
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Lüdenscheid, Germany
- Recruiting
- Märkische Kliniken Lüdenscheid
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Magdeburg, Germany
- Recruiting
- Universitätsklinikum Magdeburg
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Mainz, Germany
- Recruiting
- Universitätsklinikum Mainz
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Mannheim, Germany
- Recruiting
- Klinikum Mannheim
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Marburg, Germany
- Recruiting
- Universitätsklinikum Marburg
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Meschede, Germany
- Recruiting
- Klinikum Hochsauerland Meschede
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Minden, Germany
- Recruiting
- Johannes Wesling Klinikum Minden
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Mutlangen, Germany
- Recruiting
- Stauferklinikum Mutlangen
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Mönchengladbach, Germany
- Recruiting
- Kliniken Maria Hilf Mönchengladbach
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München, Germany
- Recruiting
- Rotkreuzklinikum München
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München, Germany
- Recruiting
- Klinikum rechts der Isar der TU Munchen
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München, Germany
- Recruiting
- Klinikum München-Bogenhausen
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München, Germany
- Recruiting
- Städtisches Krankenhaus München-Neuperlach
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München, Germany
- Recruiting
- Universitätsklinikum München-Großhadern
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Münster, Germany
- Recruiting
- Universitätsklinikum Münster
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Neubrandenburg, Germany
- Recruiting
- Dietrich-Bonhoeffer-Klinikum Neubrandenburg
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Nordhausen, Germany
- Recruiting
- Südharz Klinikum Nordhausen
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Nuremberg, Germany
- Recruiting
- Klinikum Nürnberg Nord
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Offenburg, Germany
- Recruiting
- Ortenau Klinikum Offenburg
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Oldenburg, Germany
- Recruiting
- Klinikum Oldenburg
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Oldenburg, Germany
- Recruiting
- Pius-Hospital Oldenburg
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Osnabrück, Germany
- Recruiting
- Klinikum Osnabrück
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Paderborn, Germany
- Recruiting
- Brüderkrankenhaus St. Josef Paderborn
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Passau, Germany
- Recruiting
- Klinikum Passau
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Potsdam, Germany
- Recruiting
- Klinikum Ernst von Bergmann
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Recklinghausen, Germany
- Recruiting
- Kliniken Vest Recklinghausen
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Regensburg, Germany
- Recruiting
- Krankenhaus Barmherzige Brüder Regensburg
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Regensburg, Germany
- Recruiting
- Universitätsklinikum Regensburg
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Reutlingen, Germany
- Recruiting
- Kreiskliniken Reutlingen
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Riesa, Germany
- Recruiting
- Elblandklinikum Riesa
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Rostock, Germany
- Recruiting
- Universitätsklinikum Rostock
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Rostock, Germany
- Recruiting
- Klinikum Südstadt Rostock
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Rotenburg (Wümme), Germany
- Recruiting
- Diakoniekrankenhaus Rotenburg
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Saarlouis, Germany
- Recruiting
- Marienhaus Klinikum Saarlouis
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Sande, Germany
- Recruiting
- Nordwest-Krankenhaus Sanderbusch
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Schwerin, Germany
- Recruiting
- HELIOS Klinikum Schwerin
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Schwäbisch Hall, Germany
- Recruiting
- Diakonie-Krankenhaus
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Siegen, Germany
- Recruiting
- Ev. Jung-Stilling Krankenhaus Siegen
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Siegen, Germany
- Recruiting
- St. Marienkrankenhaus Siegen
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Sindelfingen, Germany
- Recruiting
- Klinikum Südwest Sindelfingen
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Speyer, Germany
- Recruiting
- Diakonissen-Stiftungs-Krankenhaus Speyer
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Stuttgart, Germany
- Recruiting
- Marienhospital Stuttgart
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Stuttgart, Germany
- Recruiting
- Robert-Bosch-Krankenhaus
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Stuttgart, Germany
- Recruiting
- Diakonie-Klinikum Stuttgart
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Stuttgart, Germany
- Recruiting
- Klinikum Stuttgart Katharinenhospital
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Traunstein, Germany
- Recruiting
- Klinikum Traunstein
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Trier, Germany
- Recruiting
- Krankenhaus der Barmherzigen Brüder
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Trier, Germany
- Recruiting
- Mutterhaus der Borromäerinnen Trier
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Tübingen, Germany
- Recruiting
- Universitatsklinikum Tubingen
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Ulm, Germany
- Recruiting
- Medizinische Universitätsklinikum Ulm
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Villingen-Schwenningen, Germany
- Recruiting
- Klinikum Schwarzwald-Baar Villingen
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Wiesbaden, Germany
- Recruiting
- Helios Dr. Horst Schmidt Kliniken Wiesbaden
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Winnenden, Germany
- Recruiting
- Rems-Murr-Kliniken Winnenden
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Wolfsburg, Germany
- Recruiting
- Klinikum der Stadt Wolfsburg
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Wuppertal, Germany
- Recruiting
- Helios Klinikum Wuppertal
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Würzburg, Germany
- Recruiting
- Universitätsklinikum Würzburg
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Zwickau, Germany
- Recruiting
- Heinrich-Braun-Klinikum Zwickau
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Hesse
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Frankfurt am Main, Hesse, Germany, 60590
- Recruiting
- University Hospital of Frankfurt (Main)
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Contact:
- GMALL Study Center
- Phone Number: +496963016366
- Email: gmall@em.uni-frankfurt.de
-
Principal Investigator:
- Nicola Gökbuget, Dr. med.
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Acute Lymphoblastic Leukemia (All Subtypes) if treated according to ALL protocols
- Other Types of Leukemia (NK Cell Lymphoma/Leukemia, Biphenotypic Acute Leukemia) if treated according to ALL protocols
- Non-Hodgkin's Lymphoma of Following Subtypes: Burkitt Lymphoma, B Cell Lymphoma, B- or T-lineage Lymphoblastic Lymphoma, Anaplastic Large Cell Lymphoma, Other NHL) if treated according to B-ALL protocols
- Age minimum 18 yrs
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
|---|
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B-ALL/NHL
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ALL/ Lymphoblastic Lymphoma (LBL)
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival
Time Frame: up to 10 years
|
up to 10 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Disease free survival
Time Frame: up to 10 years
|
up to 10 years
|
|
Remission duration
Time Frame: up to 10 years
|
up to 10 years
|
|
Relapse rate
Time Frame: up to 10 years
|
up to 10 years
|
|
Event free survival
Time Frame: up to 10 years
|
up to 10 years
|
|
Hematologic remission rate
Time Frame: after induction and consolidation, approximately 6 - 8 weeks from diagnosis
|
after induction and consolidation, approximately 6 - 8 weeks from diagnosis
|
|
Molecular remission rate
Time Frame: after induction and consolidation, approximately 6 - 8 weeks from diagnosis
|
after induction and consolidation, approximately 6 - 8 weeks from diagnosis
|
|
Positron Emission Tomography (PET) based remission evaluation
Time Frame: after induction and consolidation, approximately 6 - 8 weeks from diagnosis
|
after induction and consolidation, approximately 6 - 8 weeks from diagnosis
|
|
Early mortality
Time Frame: during induction therapy with a duration of approximately 6 - 8 weeks
|
during induction therapy with a duration of approximately 6 - 8 weeks
|
|
Mortality in Clinical Remission (CR)
Time Frame: up to 10 years
|
up to 10 years
|
|
Comorbidities
Time Frame: Time of diagnosis and up to 10 years during regular follow-up requests which are not pre-specified
|
Time of diagnosis and up to 10 years during regular follow-up requests which are not pre-specified
|
|
Quality of life assessed by Quality of Life Questionnaire (QLQ-C30)
Time Frame: after treatment which is approximately 2.5 years from diagnosis
|
after treatment which is approximately 2.5 years from diagnosis
|
|
Eastern Cooperative Oncology Group (ECOG) status
Time Frame: Time of diagnosis and up to 10 years during regular follow-up requests which are not pre-specified
|
Time of diagnosis and up to 10 years during regular follow-up requests which are not pre-specified
|
|
Toxicities assessed by CTCAE v4.03
Time Frame: during treatment with an approximate duration of 2.5 years from diagnosis
|
during treatment with an approximate duration of 2.5 years from diagnosis
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Nicola Gökbuget, Dr. med., University Hospital of Frankfurt (Main)
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- GMALL_Registry
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.