acute lymphoblastic leukemia in children and adolescents
Conditions
Brief summary
B/SR: Disease-free survival time: Time from randomization (R-SR) until the date of last follow-up or the first event defined as relapse, second malignancy or death from any cause
Detailed description
B/SR: Survival: Time from randomization until the date of last follow-up or to death from any cause., B/SR: Cumulative incidence of treatment-related mortality (in CCR), B/SR: Cumulative incidence of relapse, B/SR: Frequency of Adverse Events of interest and Serious Adverse Events in randomized protocol phases, B/SR: Number of days of inpatient treatment, B/SR: Quality of life (separate add on study)
Interventions
DRUGMETHOTREXATE
DRUGCYCLOPHOSPHAMIDE
DRUGMERCAPTOPURINE
DRUGVINCRISTINE
DRUGPEGASPARGASE
DRUGCYTARABINE
DRUGDEXAMETHASONE
DRUGTIOGUANINE
DRUGEnrylaze 10 mg/0.5 mL solution for injection/infusion.
DRUGDOXORUBICIN
Sponsors
Universitaetsklinikum Schleswig-Holstein AöR
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| B/SR: Disease-free survival time: Time from randomization (R-SR) until the date of last follow-up or the first event defined as relapse, second malignancy or death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| B/SR: Survival: Time from randomization until the date of last follow-up or to death from any cause., B/SR: Cumulative incidence of treatment-related mortality (in CCR), B/SR: Cumulative incidence of relapse, B/SR: Frequency of Adverse Events of interest and Serious Adverse Events in randomized protocol phases, B/SR: Number of days of inpatient treatment, B/SR: Quality of life (separate add on study) | — |
Outcome results
None listed