International study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine
Key facts
- Where
- Aachen, Augsburg, Berlin, Bielefeld, Bonn, Bremen, Brunswick, Cologne, Cottbus, Datteln, Dortmund, Dresden, Düsseldorf, Erfurt, Erlangen, Essen, Frankfurt Am Main, Freiburg im Breisgau, Giessen, Göttingen, Halle (Saale), Hamburg, Hanover, Heidelberg, Herdecke, Homburg, Jena, Karlsruhe, Kassel, Kiel, Koblenz, Krefeld, Leipzig, Lübeck, Magdeburg, Mainz, Mannheim, Minden, Munich, Münster, Nürnberg, Oldenburg, Ratisbon, Rostock, Stuttgart, Tuebingen, Ulm és Wuerzburg, NémetországSee the 49 sites
- Phase
- 3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How old is the patient who may join a trial?
- What type of cancer has the patient been diagnosed with?
- Is this cancer newly diagnosed, or has it come back or not responded to treatment?
- Is the patient pregnant or breastfeeding?
Where in Németország
- Universitaetsklinikum Aachen AöRAachen, NémetországTaking people
- University Hospital AugsburgAugsburg, NémetországTaking people
- Charite Universitatsmedizin Berlin KöRBerlin, NémetországTaking people
- HELIOS Klinikum Berlin Buch GmbHBerlin, NémetországTaking people
- Evangelisches Klinikum Bethel gGmbHBielefeld, NémetországTaking people
- Universitaetsklinikum Bonn AöRBonn, NémetországTaking people
- Gesundheit Nord gGmbH Klinikverbund BremenBremen, NémetországTaking people
- Staedtisches Klinikum Braunschweig gGmbHBrunswick, NémetországTaking people
- Childrens Hospital University Of CologneCologne, NémetországTaking people
- Carl Thiem Klinikum gGmbHCottbus, NémetországTaking people
- Vestische Kinder- und Jugendklinik DattelnDatteln, NémetországTaking people
- Klinikum Dortmund gGmbHDortmund, NémetországTaking people
- Technische Universität DresdenDresden, NémetországTaking people
- Universitaetsklinikum Duesseldorf AöRDüsseldorf, NémetországTaking people
- HELIOS Klinikum Erfurt GmbHErfurt, NémetországTaking people
- Universitatsklinikum Erlangen AöRErlangen, NémetországTaking people
- Universitaetsklinikum Essen (AoR)Essen, NémetországTaking people
- Universitaetsklinikum Frankfurt AöRFrankfurt Am Main, NémetországTaking people
- Medical Center- University of FreiburgFreiburg im Breisgau, NémetországTaking people
- Justus-Liebig-Universitaet GiessenGiessen, NémetországTaking people
- Universitaetsmedizin GoettingenGöttingen, NémetországTaking people
- Martin-Luther-Universitaet Halle-WittenbergHalle (Saale), NémetországTaking people
- University Medical Center Hamburg-EppendorfHamburg, NémetországTaking people
- Medizinische Hochschule HannoverHanover, NémetországTaking people
- Heidelberg University Hospital AöRHeidelberg, NémetországTaking people
- Gemeinschaftskrankenhaus Herdecke gGmbHHerdecke, NémetországTaking people
- Saarland University HospitalHomburg, NémetországTaking people
- University Hospital Jena KöRJena, NémetországTaking people
- Staedtisches Klinikum Karlsruhe gGmbHKarlsruhe, NémetországTaking people
- Klinikum Kassel GmbHKassel, NémetországTaking people
- University Medical Centre Schleswig-HolsteinKiel, NémetországTaking people
- Childrens Hospital Of KoblenzKoblenz, NémetországTaking people
- HELIOS Klinikum Krefeld GmbHKrefeld, NémetországTaking people
- University of LeipzigLeipzig, NémetországTaking people
- University Medical Centre Schleswig-HolsteinLübeck, NémetországTaking people
- Universitaetsklinikum Magdeburg AöRMagdeburg, NémetországTaking people
- Johannes Gutenberg University MainzMainz, NémetországTaking people
- Klinikum MannheimMannheim, NémetországTaking people
- Johannes Wesling Klinikum MindenMinden, NémetországTaking people
- Hospital Munich SchwabingMunich, NémetországTaking people
- Universitatsklinikum Munster AöRMünster, NémetországTaking people
- Diakoneo Klinik Hallerwiese-Cnopfsche KinderklinikNürnberg, NémetországTaking people
- Klinikum Oldenburg AorOldenburg, NémetországTaking people
- Universitaetsklinikum RegensburgRatisbon, NémetországTaking people
- Rostock University Medical CenterRostock, NémetországTaking people
- Klinikum Der Landeshauptstadt Stuttgart gKAöRStuttgart, NémetországTaking people
- Universitaetsklinikum TuebingenTuebingen, NémetországTaking people
- Universitatsklinikum Ulm AöRUlm, NémetországTaking people
- Universitaetsklinikum Wuerzburg AöRWuerzburg, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GPOH gGmbH
- Trial code
- EU 2022-501454-11-00
- Record updated
- 2026. október 21.
- Original description
To show that it is possible to cure at least 75% of patients belonging to the SR group with Vinblastine-monotherapy for 24 months.Read full original descriptionShow less
International cooperative prospective study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine
To show that it is possible to cure at least 75% of patients belonging to the SR group with Vinblastine-monotherapy for 24 months.
Inclusion: Stratification into the standard risk group (SR) by screening: Newly diagnosed ALK-positive ALCL, Stage I not completely resected, or stage II or stage III, MDD negative; Age < 18 years; Informed consent of the parents/legal guardians (and assent of the competent child) for study participation and data collection, storage and handling given before study entry; Participation in national / study group's reference pathology; Follow-up for at least 3 years after enrolment is expected; Application of a highly effective contraceptive method (Pearl index <1) in sexually active patients; Application of one intrathecal triple therapy with Methotrexate, Cytarabine and Prednisolone (or Hydrocortisone respectively) before start of the protocol treatment.
Exclusion: Steroids for more than 2 days or chemotherapy pre-treatment before taking the screening sample for MDD; Chemotherapy pre-treatment before start of the study treatment except for: the obligatory initial intrathecal triple therapy with Methotrexate, Cytarabine and Prednisolone (or Hydrocortisone respectively), a possible clinically indicated pre-phase including up to 5 days of steroids combined with up to 3 doses of Vinblastine (and up to 2 doses of Cyclophosphamide); Contraindications for the treatment with Vinblastine: hypersensitivity against VBL or other vinca-alkaloids, leukopenia, other than in the context of the ALCL, severe uncontrolled infection; Progressive disease during a possible clinically indicated pre-phase treatment before inclusion in the study; Other medical, psychiatric, familial or social condition prohibiting treatment according to the protocol; Pregnancy or lactation period.