LBL Lymphoblastic lymphoma
Conditions
Interventions
N.A.
Sponsors
University Hospital Münster
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: Patients meeting the following criteria are eligible to the study (inclusion criteria): •newly diagnosed lymphoblastic lymphoma •age 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
Exclusion criteria: Patients meeting the following criteria are not eligible to the study (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 (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 (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 (except INITIAL EMERGENCIES, see page 73) •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Randomization R1: Cumulative incidence of relapse with involvement of the CNS (CNS-relapse, pCICR). The time to relapse is the time from randomization to the first relapse or the date of last follow-up. Other events (non-response, progressive disease, relapse, second malignancy or death before and in CR) will be taken into account as competing events. • Randomization R2: Estimated probability of event-free survival (pEFS). The pEFS is the time from randomization to the first event (non-response, progressive disease, relapse, second malignancy or death from any cause) or date of last follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of the trial LBL 2018 are the following: •survival (pOS) defined as time from diagnosis to death due to any cause or to the date of last contact for patients alive. •frequency of treatment-related toxicity and mortality overall and in specific protocol elements, randomized arms and during follow-up. •frequency of adverse events of interest and severe adverse events overall. •rate of evaluable patients for risk group stratification. •cumulative incidence of relapses in association with molecular markers of the published genetic classifier (PTEN mutations and deletions, PIK3R1, PIK3CA, KRAS, NRAS, chromosome 6q alterations, status of TRG locus) and targeted panel. •cumulative incidence of relapses in association with minimal residual disease results. | — |
Countries
Netherlands
Outcome results
None listed