Blinatumomab overcomes poor prognostic impact of measurable residual disease in pediatric high-risk first relapse B-cell precursor acute lymphoblastic leukemia
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, časopisecké články
PubMed
35482538
DOI
10.1002/pbc.29715
Knihovny.cz E-zdroje
- Klíčová slova
- MRD, acute lymphoblastic leukemia, blinatumomab, pediatric, prognosis,
- 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
- Názvy látek
- blinatumomab MeSH Prohlížeč
- protilátky bispecifické * 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.
Amgen Inc Thousand Oaks California USA
Amgen Research GmbH Munich Germany
Charite Universitatsmedizin Berlin Berlin Germany
Charles University Motol University Hospital Prague Czech Republic
IRCCS Ospedale Pediatrico Bambino Gesù and Sapienza University of Rome Rome Italy
Maternal and Child Health Department University of Padua Padua Italy
Zobrazit více v PubMed
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ClinicalTrials.gov
NCT02393859
