Status:
RECRUITING
International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
Lead Sponsor:
University Hospital Muenster
Collaborating Sponsors:
Deutsche Krebshilfe e.V., Bonn (Germany)
Conditions:
Lymphoblastic Lymphoma, Childhood
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
Brief Summary
Primary objectives: * Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified...
Detailed Description
The trial LBL 2018 is a collaborative prospective, multi-national, multi-center, randomized clinical trial for the treatment of children and adolescents with newly diagnosed lymphoblastic lymphoma. T...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- newly diagnosed lymphoblastic lymphoma
- age \<18 years
- 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 (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
- 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
Exclusion
Key Trial Info
Start Date :
August 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 22 2027
Estimated Enrollment :
683 Patients enrolled
Trial Details
Trial ID
NCT04043494
Start Date
August 23 2019
End Date
November 22 2027
Last Update
March 21 2025
Active Locations (228)
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1
Univ.Klinik für Kinder- und Jugendheilkunde Graz, Klin. Abteilung für pädiatrische Hämato-Onkologie
Graz, Austria, 8036
2
Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck, Universitätsklinik für Pädiatrie I
Innsbruck, Austria, 6020
3
Kepler Universitätsklinikum, Med Campus IV / Onkologie
Linz, Austria, 4020
4
LKH Salzburg, Universitätsklinik für Kinder- und Jugendheilkunde, Kinderonkologie
Salzburg, Austria, 5020