Tests treatment regimens for children and teens with lymphoblastic lymphoma
Compares two chemotherapy approaches in children and teens with lymphoblastic lymphoma.
Plain-language title generated from the registry record
Registry title: International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
Key facts
- Where
- Graz, Innsbruck, Linz, Salzburg, and Vienna, AustriaSee the 5 sites
- Phase
- Phase 3
AI summary: who the study is looking for
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 adolescents under 18 with newly diagnosed lymphoblastic lymphoma, treated at a participating center.
- Age
- Under 18 years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed lymphoblastic lymphoma. Some patients with high risk disease can join an extra treatment comparison.
- Earlier treatment
- Cannot have had steroids of 1 mg/kg/d or more for over two weeks in the last month before diagnosis. Cannot have had live vaccines within 2 weeks before treatment starts. Cannot have started treatment under another protocol or had cytostatic drugs.
Main reasons for not taking part
- Lymphoblastic lymphoma as a second cancer
- Prior organ transplant or severe immunodeficiency
- Serious infections such as HIV, VZV or tuberculosis
- Severe kidney or liver problems, or heart failure
- Pregnancy or breastfeeding
Read by machine on 9 November 2026.
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?
- Does the patient have an infection that is not under control, or HIV or hepatitis B or C?
Source: NCT04043494, who can take part
Where in Austria
- Medical University of GrazGraz, AustriaTaking people
- Medizinische Universitaet InnsbruckInnsbruck, AustriaTaking people
- Kepler Universitaetsklinikum GmbHLinz, AustriaTaking people
- Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbHSalzburg, AustriaTaking people
- St. Anna Kinderspital GmbHVienna, AustriaTaking 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
- University Hospital Muenster
- Trial code
- NCT04043494EU 2023-508101-24-00
- Record updated
- 6 May 2026
- Original description
Primary objectives:Read full original descriptionShow less
LBL 2018 - International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
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: 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: 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; sexually active adolescents not willing to use highly effective contraceptive method (pearl index < 1) until 12 months after end of cytostatic therapy; 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); 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.