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
- Bialystok, Bydgoszcz, Cracow, Gdansk, Katowice, Kielce, Lodz, Lublin, Olsztyn, Poznan, Rzeszów, Szczecin, Warsaw, Wroclaw, and Zabrze, PolandSee the 16 sites
- Phase
- Phase 3
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 Poland
- Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku samodzielny publiczny zakład opieki zdrowotnejBialystok, PolandTaking people
- Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W BydgoszczyBydgoszcz, PolandTaking people
- Uniwersytecki Szpital Dzieciecy W KrakowieCracow, PolandTaking people
- Uniwersyteckie Centrum KliniczneGdansk, PolandTaking people
- Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W KatowicachKatowice, PolandTaking people
- Wojewodzki Szpital Zespolony W Kielcach SPZOZKielce, PolandTaking people
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W LodziLodz, PolandTaking people
- Uniwersytecki Szpital Dziecięcy w LublinieLublin, PolandTaking people
- Wojewodzki Specjalistyczny Szpital Dzieciecy Im. Prof. Dr Stanislawa Popowskiego W Olsztynie Sp. z o.o.Olsztyn, PolandTaking people
- Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W PoznaniuPoznan, PolandTaking people
- Kliniczny Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej w RzeszowieRzeszów, PolandTaking people
- Samodzielny Publiczny Szpital Kliniczny Nr 1 Im Prof. Tadeusza Sokolowskiego Pomorskiego Uniwersytetu Medycznego W SzczecinieSzczecin, PolandTaking people
- Instytut Pomnik Centrum Zdrowia DzieckaWarsaw, PolandTaking people
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu MedycznegoWarsaw, PolandTaking people
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we WroclawiuWroclaw, PolandTaking people
- Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W KatowicachZabrze, PolandTaking 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.