Frontlight ResearchEarly access
Taking people in GermanyPhase 3
Vinblastine alone for children and teens with a lymphoma
Tests vinblastine alone in young people with a standard risk lymphoma.
Key facts
- Who runs it
- GPOH gGmbH
- 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, and Wuerzburg, GermanySee the 49 sitesAlso in 7 other countries, 57 sites
- Registry title
- International study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 137 people, planned
- Started
- 5 Feb 2020
- Expected to end
- 6 Jan 2028
- Type of study
- Interventional
- Record updated
- 21 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers under 18 with newly diagnosed ALK-positive anaplastic large cell lymphoma (ALCL) in the standard risk group.
- Age
- Under 18 years
- Sex
- All sexes
- Disease stage
- Newly diagnosed ALK-positive ALCL, standard risk group: stage I not completely resected, or stage II or stage III, MDD negative.
- Earlier treatment
- Before the study, only one intrathecal triple therapy with Methotrexate, Cytarabine and Prednisolone (or Hydrocortisone) is required. Other chemotherapy is not allowed, except a possible short pre-phase of up to 5 days of steroids with up to 3 doses of Vinblastine (and up to 2 doses of Cyclophosphamide).
- Biomarker or test result
- ALK-positive ALCL, MDD negative.
Main reasons for not taking part
- Disease that got worse during a pre-phase treatment before joining
- Steroids for more than 2 days or chemotherapy before the screening sample for MDD was taken
- Pregnancy or breastfeeding
- Cannot take Vinblastine: allergy to Vinblastine or other vinca-alkaloids, low white blood cells not caused by ALCL, or severe uncontrolled infection
- Other medical, mental health, family or social conditions that prevent treatment according to the protocol
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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 Germany
Also in 7 other countries, 57 sites
- Universitaetsklinikum Aachen AöRAachen, GermanyTaking people
- University Hospital AugsburgAugsburg, GermanyTaking people
- Charite Universitatsmedizin Berlin KöRBerlin, GermanyTaking people
- HELIOS Klinikum Berlin Buch GmbHBerlin, GermanyTaking people
- Evangelisches Klinikum Bethel gGmbHBielefeld, GermanyTaking people
- Universitaetsklinikum Bonn AöRBonn, GermanyTaking people
- Gesundheit Nord gGmbH Klinikverbund BremenBremen, GermanyTaking people
- Staedtisches Klinikum Braunschweig gGmbHBrunswick, GermanyTaking people
- Childrens Hospital University Of CologneCologne, GermanyTaking people
- Carl Thiem Klinikum gGmbHCottbus, GermanyTaking people
- Vestische Kinder- und Jugendklinik DattelnDatteln, GermanyTaking people
- Klinikum Dortmund gGmbHDortmund, GermanyTaking people
- Technische Universität DresdenDresden, GermanyTaking people
- Universitaetsklinikum Duesseldorf AöRDüsseldorf, GermanyTaking people
- HELIOS Klinikum Erfurt GmbHErfurt, GermanyTaking people
- Universitatsklinikum Erlangen AöRErlangen, GermanyTaking people
- Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
- Universitaetsklinikum Frankfurt AöRFrankfurt Am Main, GermanyTaking people
- Medical Center- University of FreiburgFreiburg im Breisgau, GermanyTaking people
- Justus-Liebig-Universitaet GiessenGiessen, GermanyTaking people
- Universitaetsmedizin GoettingenGöttingen, GermanyTaking people
- Martin-Luther-Universitaet Halle-WittenbergHalle (Saale), GermanyTaking people
- University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
- Medizinische Hochschule HannoverHanover, GermanyTaking people
- Heidelberg University Hospital AöRHeidelberg, GermanyTaking people
- Gemeinschaftskrankenhaus Herdecke gGmbHHerdecke, GermanyTaking people
- Saarland University HospitalHomburg, GermanyTaking people
- University Hospital Jena KöRJena, GermanyTaking people
- Staedtisches Klinikum Karlsruhe gGmbHKarlsruhe, GermanyTaking people
- Klinikum Kassel GmbHKassel, GermanyTaking people
- University Medical Centre Schleswig-HolsteinKiel, GermanyTaking people
- Childrens Hospital Of KoblenzKoblenz, GermanyTaking people
- HELIOS Klinikum Krefeld GmbHKrefeld, GermanyTaking people
- University of LeipzigLeipzig, GermanyTaking people
- University Medical Centre Schleswig-HolsteinLübeck, GermanyTaking people
- Universitaetsklinikum Magdeburg AöRMagdeburg, GermanyTaking people
- Johannes Gutenberg University MainzMainz, GermanyTaking people
- Klinikum MannheimMannheim, GermanyTaking people
- Johannes Wesling Klinikum MindenMinden, GermanyTaking people
- Hospital Munich SchwabingMunich, GermanyTaking people
- Universitatsklinikum Munster AöRMünster, GermanyTaking people
- Diakoneo Klinik Hallerwiese-Cnopfsche KinderklinikNürnberg, GermanyTaking people
- Klinikum Oldenburg AorOldenburg, GermanyTaking people
- Universitaetsklinikum RegensburgRatisbon, GermanyTaking people
- Rostock University Medical CenterRostock, GermanyTaking people
- Klinikum Der Landeshauptstadt Stuttgart gKAöRStuttgart, GermanyTaking people
- Universitaetsklinikum TuebingenTuebingen, GermanyTaking people
- Universitatsklinikum Ulm AöRUlm, GermanyTaking people
- Universitaetsklinikum Wuerzburg AöRWuerzburg, GermanyTaking people
About the trial
What the trial wants to find out
To show that it is possible to cure at least 75% of patients belonging to the SR group with Vinblastine-monotherapy for 24 months.
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- International cooperative prospective study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine
- Plain-language title
- Vinblastine alone for children and teens with a lymphomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Fit questions
- Built from 2022-501454-11-00, who can take part
- Record updated
- 21 October 2026