International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

• Status: Recruiting
• Trial end date: 2027-10-31
• Target enrollment: 0
• Participant gender: All

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 induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm)

• Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Muenster
• Collaborator: Deutsche Krebshilfe e.V., Bonn (Germany)
• Treatments: Asparaginase; BB 1101; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Dexamethasone acetate; Doxorubicin; Ifosfamide; Mercaptopurine; Methotrexate; Pegaspargase; Prednisolone; Prednisone; Thioguanine; Vincristine; Vindesine

Criteria

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