NCT04043494Recruiting
International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
Summary
Primary objectives: * Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm) * Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02)
Inclusion criteria
• newly diagnosed lymphoblastic lymphoma • age \<18 years • patient enrolled in a participating center • written informed consent of patient (\>14 years of age or according to local law and regulation) and parents to trial participation and transfer and processing of data • willingness of patients and the investigator/pathologist to provide adequate slides/blocks for reference (molecular) pathology and international pathology panel and/or fresh or fresh frozen samples for genetic risk group stratification if these samples are available after standard diagnostic procedures.
Exclusion criteria
• lymphoblastic lymphoma as secondary malignancy • non-lymphoma related relevant medical, psychiatric or social conditions incompatible with trial treatment, including among others • prior organ transplant • severe immunodeficiency • demyelinating Charcot-Marie Tooth syndrome • serious acute or chronic infections, such as HIV, VZV and tuberculosis • urinary tract infection, cystitis, urinary outflow obstruction, severe renal impairment (creatinine clearance less than 20 ml/min) • severe hepatic impairment (bilirubin \>3 times ULN, transaminases \>10 times ULN) • myocardial insufficiency, severe arrhythmias • ulcers of the oral cavity and known active gastrointestinal ulcer disease • known hypersensitivity to any IMP and to any excipient (listed in section 6.1 of the respective SmPC) • steroid pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month before diagnosis • vaccination with live vaccines within 2 weeks before start of protocol treatment • treatment started according to another protocol or pre-treatment with cytostatic drugs • participation in another clinical trial that interferes with the protocol, except NHL-BFM Registry 2012 and trials with different endpoints, involving aspects of supportive treatment, which can run parallel to LBL 2018 without influencing the outcome of this trial (e.g. trials on antiemetics, antibiotics, strategies for psychosocial support) • evidence of pregnancy or lactation period • sexually active adolescents not willing to use highly effective contraceptive method (pearl index \< 1) until 12 months after end of cytostatic therapy
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, Belgium, China, Czechia, Denmark, Finland, Hungary, Ireland, Israel, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Spain, Sweden
- Sponsor
- University Hospital Muenster(Other)
- Protocol no.
- UKM17_0023
- Conditions
- Lymphoblastic Lymphoma, Childhood
- Interventions
- Drug
Treatments studied
- Cyclophosphamide
- Cytarabine
- Dexamethasone
- Daunorubicin
- Doxorubicin
- Ifosfamide
- 6-Mercaptopurine
- Methotrexate
- PEG asparaginase
- Prednisone
- Prednisolone
- Thioguanine
- Vincristine
- Vindesine
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany)
Locations · 137
- Aachen, GermanyUniversitätsklinikum Aachen .Klinik für Kinder - und Jugendmedizin Hämatologie / OnkologieRecruiting at this site
- Augsburg, GermanyKlinikum Augsburg ,Schwäbisches Kinderkrebszentrum. I. Klinik für Kinder und Jugendliche Hämatologie / OnkologieRecruiting at this site
- Berlin, GermanyHELIOS Klinikum Berlin-Buch, Kinderklinik, Pädiatrische Hämatologie und OnkologieRecruiting at this site
- Berlin, GermanyCharité Campus Virchow-Klinikum, Zentrum für Kinder- und Jugendmedizin- Abt. Hämatologie / OnkologieRecruiting at this site
- Bielefeld, GermanyEvangelisches Krankenhaus Bielefeld GmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie und OnkologieRecruiting at this site
- Bonn, GermanyZentrum für Kinderheilkunde der Universität Bonn, Abt. Päd. Hämatologie / OnkologieRecruiting at this site
- Braunschweig, GermanyStädtisches Klinikum Braunschweig gGmbH, Zentrum für Kinder- und JugendmedizinRecruiting at this site
- Bremen, GermanyKlinikum Bremen-Mitte gGmbH, Prof.-Hess-Kinderklinik,Pädiatrische Onkologie und HämatologieRecruiting at this site
- Cottbus, GermanyCarl-Thiem-Klinikum, Kinderklinik, Station 5eRecruiting at this site
- Datteln, GermanyVestische Kinderklinik, Universität Witten / HerdeckeRecruiting at this site
- Dortmund, GermanyKlinikum Dortmund gGmbH, Klinik für Kinder- und Jugendmedizin, Station K1, Abt. Päd. Onkologie / HämatologieRecruiting at this site
- Dresden, GermanyUniversitätsklinik Carl Gustav Carus der TU Dresden, Klinik für Kinder- und JugendmedizinRecruiting at this site
- Düsseldorf, GermanyUniversitätsklinikum Düsseldorf, Zentrum für Kinder- und Jugendmedizin, Klinik für Päd. Hämatologie und OnkologieRecruiting at this site
- Erfurt, GermanyHELIOS Klinikum Erfurt GmbH, Klinik für Kinder- und Jugendmedizin, Päd. Onkologie / HämatologieRecruiting at this site
- Erlangen, GermanyUniversitätsklinikum Erlangen, Klinik für Kinder- und Jugendmedizin, Pädiatrische Onkologie / HämatologieRecruiting at this site
- Essen, GermanyUniversitätsklinikum Essen, Zentrum für Kinder- und Jugendmedizin, Hämatologie / OnkologieRecruiting at this site
- Frankfurt, GermanyUniversitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und OnkologieRecruiting at this site
- Freiburg im Breisgau, GermanyUniversitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Klinik IV: Päd. Hämatologie und OnkologieRecruiting at this site
- Giessen, GermanyUniversitätsklinikum Gießen und Marburg, Standort Gießen, Zentrum für Kinderhämatologie und -onkologieRecruiting at this site
- Göttingen, GermanyGeorg-August-Universität Universitäts-Kinderklinik, Pädiatrie IRecruiting at this site
- Greifswald, GermanyUniversitätsklinikum Greifswald KdöR, Klinik und Poliklinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Onkologie und HämatologieRecruiting at this site
- Halle, GermanyUniversitätsklinikum Halle (Saale), Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / OnkologieRecruiting at this site
- Hamburg, GermanyUniversitätsklinikum Hamburg Eppendorf, Zentrum für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und OnkologieRecruiting at this site
- Hanover, GermanyMedizinische Hochschule Hannover, Kinderheilkunde, Päd. Hämatologie / OnkologieRecruiting at this site
- Heidelberg, GermanyUniversitäts-Kinderklinik Heidelberg, Abt. Hämatologie / OnkologieRecruiting at this site
- Herdecke, GermanyGemeinschaftskrankenhaus Herdecke, Kinder- und Jugendmedizin, Päd. Hämatologie / OnkologieRecruiting at this site
- Homburg, GermanyUniversitätskliniken für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie, Geb. 9Recruiting at this site
- Jena, GermanyUniversitätsklinikum Jena, Klinik für Kinder- und JugendmedizinRecruiting at this site
- Karlsruhe, GermanyStädtisches Klinikum Karlsruhe gGmbH, Kinderklinik, Station S 24Recruiting at this site
- Kassel, GermanyKlinikum Kassel Gesundheit Nordhessen Holding AG, Klinik für pädiatrische Hämatologie und OnkologieRecruiting at this site
In total, worldwide, 137 of the 228 sites listed in the registry are recruiting; the other 91 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: May 6, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 107 more locations
Other identifiers
- 2017-001691-39 · EudraCT number
- 2017 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.