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

Phase 3

Recruiting

• Conditions: LBL; Lymphoblastic lymphoma; 10018865

• Registration Number: NL-OMON54528
• Lead Sponsor: niversity Hospital Münster

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 42

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

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 < 1) until 12 months after end of cytostatic therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified