• MeSH
• dítě MeSH
• indukce remise MeSH
• lidé MeSH
• lokální recidiva nádoru farmakoterapie   MeSH
• pre-B-buněčná leukemie * farmakoterapie   MeSH
• přežití po terapii bez příznaků nemoci MeSH
• protilátky bispecifické * terapeutické užití   MeSH
• recidiva MeSH
• reziduální nádor farmakoterapie   MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

BACKGROUND: Blinatumomab, a CD3/CD19 BiTE® (bispecific T cell engager) molecule, was superior to high-risk third course consolidation chemotherapy (HC3) in prolonging event-free survival (EFS) in children with high-risk first relapse B-cell precursor acute lymphoblastic leukemia (B-ALL). Here, we report results from a post hoc measurable residual disease (MRD) analysis of this phase 3 study (NCT02393859). PROCEDURE: Children >28 days and <18 years with high-risk first-relapse B-ALL in cytomorphological complete remission (M1 marrow, <5% blasts) or with M2 marrow (≥5% and <25% blasts) after induction and two cycles of high-risk consolidation chemotherapy (baseline) were enrolled in this trial. Patients received one cycle of blinatumomab (15 μg/m2 /day, 4 weeks, continuous intravenous infusion) or HC3. The primary endpoint was EFS. In this post hoc analysis, patients with MRD <10-4 by PCR were grouped as having positive but not quantifiable (pbnq) or undetectable disease. RESULTS: A higher proportion of patients with MRD <10-4 had undetectable versus pbnq disease after blinatumomab (day 29) than after HC3 (p = 0.0367). Of the 22 patients with MRD ≥10-4 at baseline who achieved MRD remission after blinatumomab, 20 (91%) achieved MRD <10-4 remission by day 15. Patients treated with blinatumomab had improved EFS and overall survival compared with those treated with HC3 independent of end-of-induction or baseline (end-of-second consolidation) MRD levels. CONCLUSIONS: Blinatumomab was more efficacious than HC3 regardless of MRD status before treatment. These data support the role of blinatumomab in inducing deep MRD remission, negating the poor prognostic value of MRD.

• MeSH
• akutní lymfatická leukemie * farmakoterapie   MeSH
• akutní nemoc MeSH
• B-buněčný lymfom * farmakoterapie   MeSH
• Burkittův lymfom * farmakoterapie   MeSH
• dítě MeSH
• lidé MeSH
• pre-B-buněčná leukemie * terapie   MeSH
• prognóza MeSH
• protilátky bispecifické * terapeutické užití   MeSH
• recidiva MeSH
• reziduální nádor chemicky indukované   farmakoterapie   MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH

Blinatumomab is a BiTE® (bispecific T-cell engager) immuno-oncology therapy, which has demonstrated significant activity in patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL); however, a subset of patients relapse. Monitoring expression of cluster of differentiation (CD)19 in relapsed patients is critical to inform sequencing of subsequent therapies. The expression of CD19 in 59 pediatric patients with R/R B-ALL was analyzed on the day of diagnosis of R/R B-ALL and on days 15 and 29 of cycle 1 of blinatumomab. Most patients treated with one cycle of blinatumomab retained expression of CD19, and would therefore be eligible for subsequent anti-CD19 CAR T-cell therapy.

• MeSH
• akutní lymfatická leukemie * farmakoterapie   MeSH
• akutní nemoc MeSH
• antigeny CD19 metabolismus   MeSH
• antitumorózní látky * škodlivé účinky   MeSH
• B-buněčný lymfom * farmakoterapie   MeSH
• dítě MeSH
• lidé MeSH
• protilátky bispecifické * MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH