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New treatment approach for children and adolescents with lymphoblastic lymphoma

LBL 2018 - International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

Phase 3 Interventional University Hospital Muenster · NCT04043494

This study is testing a new treatment plan for kids and teens with lymphoblastic lymphoma to see if it can lower the chances of their cancer coming back in the brain and improve their chances of staying cancer-free.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment683 (estimated)
AgesN/A to 18 Years
SexAll
SponsorUniversity Hospital Muenster Academic / other
Drugs / interventionsprednisone, methotrexate
Locations228 sites (Graz and 227 other locations)
Trial IDNCT04043494 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates a new treatment protocol for children and adolescents diagnosed with lymphoblastic lymphoma. It involves a randomized comparison of modified induction therapy using dexamethasone versus standard therapy with prednisone, aiming to reduce the incidence of central nervous system relapses. Additionally, for high-risk patients, the trial evaluates whether an intensified treatment regimen can improve event-free survival compared to standard treatment. The study is conducted across multiple international centers, ensuring a diverse patient population and robust data collection.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents under 18 years old with newly diagnosed lymphoblastic lymphoma.

Not a fit: Patients with lymphoblastic lymphoma as a secondary malignancy or those with severe comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to improved survival rates and reduced relapse rates for children and adolescents with lymphoblastic lymphoma.

How similar studies have performed: Previous studies have shown promising results with similar treatment approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Graz and 227 other locations

+178 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lymphoblastic Lymphoma, Childhood
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.