NCT04043494 International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
| NCT ID | NCT04043494 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital Muenster |
| Condition | Lymphoblastic Lymphoma, Childhood |
| Study Type | INTERVENTIONAL |
| Enrollment | 683 participants |
| Start Date | 2019-08-23 |
| Primary Completion | 2030-04-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 683 participants in total. It began in 2019-08-23 with a primary completion date of 2030-04-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
Eligibility 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
Contact & Investigator
Birgit Burkhardt, Prof. Dr. Dr.
PRINCIPAL INVESTIGATOR
University Hospital Muenster, Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie
Frequently Asked Questions
Who can join the NCT04043494 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Lymphoblastic Lymphoma, Childhood. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04043494 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 683 participants.
Is NCT04043494 currently recruiting?
Yes, NCT04043494 is actively recruiting participants. Contact the research team at LBL2018@ukmuenster.de for enrollment information.
Where is the NCT04043494 trial being conducted?
This trial is being conducted at Graz, Austria, Innsbruck, Austria, Linz, Austria, Salzburg, Austria and 11 additional locations.
Who is sponsoring the NCT04043494 clinical trial?
NCT04043494 is sponsored by University Hospital Muenster. The principal investigator is Birgit Burkhardt, Prof. Dr. Dr. at University Hospital Muenster, Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie. The trial plans to enroll 683 participants.