BL 2018 - International cooperative treatment protocol for children and adolescents with lymphoblastic lymphoma

Phase 1

Recruiting

• Conditions: ymphoblastic lymphoma; MedDRA version: 21.0Level: LLTClassification code: 10065923Term: Lymphoblastic lymphoma Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-508101-24-00
• Lead Sponsor: niversitaetsklinikum Muenster AöR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-04
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 559

Inclusion 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.

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, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified