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LBL 2018 - International cooperative treatment protocol for children and adolescents with lymphoblastic lymphoma
EU CTIS ID: 2023-508101-24-00
What this study is testing
The primary objective of the first randomized question (R1) open for all LBL patients (pts) of the core study cohort, is to evaluate whether the cumulative incidence of relapses in the central nervous system can be decreased by substituting prednisone (60 mg/m²/d for 21 days plus a 9 day tapering) (standard arm, SA) by dexamethasone (10 mg/m²/d for 14 days without tapering) (experimental arm, EA) in induction therapy. The primary objective of the second randomized question (R2) open for high-risk pts of the core study cohort, is to test whether the probability of pEFS can be improved by an intensified treatment arm (EA) compared to the standard treatment arm (SA). In the EA pts receive 2 additional doses of PEG asparaginase during protocol Ib and an intensified protocol M consisting of one course for high-risk (HR) ALL (HR-1'), followed by one standard high-dose methotrexate (MTX) course, followed by another intense course for HR ALL (HR-2') and a second standard high-dose MTX course.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Newly diagnosed lymphoblastic lymphoma
- Age <18 years at diagnosis
- 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.
You likely can't join if
- 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 (e.g. 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
- 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 (except INITIAL EMERGENCIES)
- 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)
See the full eligibility criteria
- Newly diagnosed lymphoblastic lymphoma
- Age <18 years at diagnosis
- 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.
- 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 (e.g. 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
- 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 (except INITIAL EMERGENCIES)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.