International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 - A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group - IntReALL BCP 2020
BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.Solu-Dacortin 250 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung oder InfusionslösungDEXAMETHASONE MEDISOL 8 mg/2 mlsolution injectableCyclophosphamid beta 500 mg/ml Konzentrat zur Herstellung einer Injektions-/InfusionslösungINOTUZUMAB OZOGAMICINVincristine Sulfate 1 mg/ml solution for injectionOncaspar 750 U/ml powder for solution for injection/infusionHOLOXAN 1000 mg Pulver zur Herstellung einer InjektionslösungThioguanin "Aspen" 40mg TablettenCytarabin Accord 100 mg/ml Injektions-/InfusionslösungZavedos® 5 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Wirkstoff: IdarubicinhydrochloridMetex 50 mg/ml injekcinis tirpalas užpildytame švirkšteMitoxantrone 2 mg/ml concentrate for solution for infusionELDISINE® 5 mg Pulver zur Herstellung einer Injektionslösung VindesinsulfatEtoposide 20 mg/ml Concentrate for Solution for InfusionCytarabine Accord Healthcare 20 mg/ml injektio-/infuusionesteliuosDaunoblastin 20 mg Pulver zur Herstellung einer Infusions- oder InjektionslösungMETHOTREXATEMETHOTREXATEMercaptopurine 50mg tablets
Eligibility
Age group
18-64 years, 0-17 years
Sex
Female, Male
Primary endpoint
SR induction: Event-free survival (EFS), SR-MRD good response consolidation: DFS, HR with CR2 consolidation: DFS, IEM: EFS
Endpoint detail
SR induction: MRD negativity rate after induction, SR induction: Proportion of patients requiring allo-HSCT, SR induction: OS, SR induction: Toxicity (assessed by CTCAE grades and SAE reports), SR induction: Rate of patients with CD19 positive cells after SCB1 prior to Blinatumomab, SR-MRD good response consolidation: OS, SR-MRD good response consolidation: Toxicity (quantified by CTCAE grades and SAE reports), HR with CR2 consolidation: OS, HR with CR2 consolidation: MRD negativity rates before allo-HSCT, HR with CR2 consolidation: allo-HSCT rates, IEM: EFS by MRD at relapse diagnosis (cut-off 10-4), IEM: OS, IEM: DFS by MRD after induction (cut-off 10-4) in patients with BM MRD > 10e-4 at relapse, Serum pharmacokinetic parameters of InO (Cmax and Ctrough)
Official registry record
This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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