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

Phase 1

• Conditions: ymphoblastic lymphoma; MedDRA version: 21.0Level: LLTClassification code 10065923Term: Lymphoblastic lymphomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001691-39-AT
• Lead Sponsor: niversity Hospital Münster

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-21
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 683

Inclusion Criteria

Patients meeting the following criteria are eligible to the study (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
Are the trial subjects under 18? yes
Number of subjects for this age range: 683
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
•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 < 1) until 12 months after end of cytostatic therapy

Study & Design

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