New treatment approach for children and adolescents with lymphoblastic lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Univ.Klinik für Kinder- und Jugendheilkunde Graz, Klin. Abteilung für pädiatrische Hämato-Onkologie
  Graz, Austria Recruiting
• Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck, Universitätsklinik für Pädiatrie I
  Innsbruck, Austria Recruiting
• Kepler Universitätsklinikum, Med Campus IV / Onkologie
  Linz, Austria Recruiting
• LKH Salzburg, Universitätsklinik für Kinder- und Jugendheilkunde, Kinderonkologie
  Salzburg, Austria Recruiting
• St. Anna Kinderspital
  Vienna, Austria Recruiting
• Hôpital Universitaire des Enfants Reine Fabiola (ULB), Pédiatrie hémato-oncologie
  Brussels, Belgium Recruiting

+178 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Birgit Burkhardt, Prof. Dr. Dr. — University Hospital Muenster, Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie
• Study coordinator: Birgit Burkhardt, Prof. Dr. Dr.
• Email: LBL2018@ukmuenster.de
• Phone: +49 251 83 55696

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.