Prospective multicenter clinical trial for risk estimation and treatment stratification in low and intermediate risk neuroblastoma patients - NB2015-LR

Trial details

Who runs it

University Of Cologne

Trial code

EU 2024-517295-37-00

Record updated

2026. október 13.

Original description

Improvement of event free survival (EFS) of patients with intensified treatment and no impairment of EFS of patients with reduced treatment after treatment allocation by expressionTelomere maintenance mechanisms-(TMM-)based risk stratification.Read full original descriptionShow less

Improvement of event free survival (EFS) of patients with intensified treatment and no impairment of EFS of patients with reduced treatment after treatment allocation by expressionTelomere maintenance mechanisms-(TMM-)based risk stratification.

Inclusion: Neuroblastoma diagnosed according to the accepted criteria: histological diagnosis from tumor tissue or presence of distinct neuroblastoma cells in the bone marrow and elevated catecholamine metabolites (HVA, VMA) in blood or urine; MYCN not amplified; Stage and age either: a. localized neuroblastoma INRGSS stage L1/L2/INSS stage 1-3 and age at diagnosis ≥18 months and < 21 years b. INSS Stage 4S/INRGSS stage MS c. INSS Stage 4/INRGSS stage M and age at diagnosis <18 months d. INRGSS stage L1/L2 and age at first diagnosis <18 months with relapse or progression of neuroblastoma; Sufficient tumor tissue available from initial diagnosis available for analysis of TMM status; Guardians’ informed consent and/ or patient’s informed consent if appropriate according to age and status of psycho-intellectual development.

Exclusion: HIV infection because of the antiretroviral medication which potentially interferes with the metabolism of the scheduled investigational drugs; Insufficient contraception for sexually active study participants as well as female partners of sexually active male trial participants. Patients must be informed about the need of adequate contraception. Moreover, this need for contraception must be understood by the trial participants. Only contraception with a Pearl index <1% are considered as sufficient. For the purpose of this trial, these are long-term parenteral hormones, progesterone releasing implants, intramuscular progesterone, and intrauterine hormone releasing devices, tubal ligation, and vaginal hormonal contraception. This also holds true for adolescents who are at risk to become sexually active during trial participation; Any concomitant non-protocol anticancer therapy; History of earlier VOD/SOS of the liver; Known allergy/hypersensitivity to the scheduled drugs; Impaired renal function defined by a reduced glomerular filtration rate <30 ml/min*1,73 m2 determined by serum creatinine (Schwartz formula) or serum cystatin C; Impaired liver function corresponding to CTCAE 5.0 grade 3 or higher unless liver impairment is clearly caused by neuroblastoma in stage 4S/MS patients. Isolated elevation of the transaminases without evidence of impaired liver function is not an exclusion criterion; Impaired cardiac function such as insufficiency, heart rate abnormalities and blood pressure abnormalities corresponding to CTCAE 5.0 grade 2 or higher. Hypertension according to age specific reference values clearly due to neuroblastoma is no exclusion criterion; Participation in other clinical trials; Impaired bone marrow function defined by granulocytes <500/μl and/or thrombocytes <50.000/μl unless clearly caused by bone marrow involvement proven by bone marrow cytology or diffuse abnormal osteomedullary signal in the mIBG scintigraphy; Pregnancy or lactation; Incomplete initial staging.

EU CTIS 2024-517295-37-00