The DOI matches its Crossref record; 26 of the 26 references it cites were found in a registry or an index.
Phase I/Phase II Study of Blinatumomab in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia
Open accessAbstract
Purpose: Blinatumomab is a bispecific T-cell engager antibody construct targeting CD19 on B-cell lymphoblasts. We evaluated the safety, pharmacokinetics, recommended dosage, and potential for efficacy of blinatumomab in children with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL). Methods: This open-label study enrolled children < 18 years old with relapsed/refractory BCP-ALL in a phase I dosage-escalation part and a phase II part, using 6-week treatment cycles. Primary end points were maximum-tolerated dosage (phase I) and complete remission rate within the first two cycles (phase II). Results: We treated 49 patients in phase I and 44 patients in phase II. Four patients had dose-limiting toxicities in cycle 1 (phase I). Three experienced grade 4 cytokine-release syndrome (one attributed to grade 5 cardiac failure); one had fatal respiratory failure. The maximum-tolerated dosage was 15 µg/m 2/d. Blinatumomab pharmacokinetics was linear across dosage levels and consistent among age groups. On the basis of the phase I data, the recommended blinatumomab dosage for children with relapsed/refractory ALL was 5 µg/m 2/d for the first 7 days, followed by 15 µg/m 2/d thereafter. Among the 70 patients who received the recommended dosage, 27 (39%; 95% CI, 27% to 51%) achieved complete remission within the first two cycles, 14 (52%) of whom achieved complete minimal residual disease response. The most frequent grade ≥ 3 adverse events were anemia (36%), thrombocytopenia (21%), and hypokalemia (17%). Three patients (4%) and one patient (1%) had cytokine-release syndrome of grade 3 and 4, respectively. Two patients (3%) interrupted treatment after grade 2 seizures. Conclusion: This trial, which to the best of our knowledge was the first such trial in pediatrics, demonstrated antileukemic activity of single-agent blinatumomab with complete minimal residual disease response in children with relapsed/refractory BCP-ALL. Blinatumomab may represent an important new treatment option in this setting, requiring further investigation in curative indications.
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Cites
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Chimeric Antigen Receptor–Modified T Cells for Acute Lymphoid Leukemia
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Maude, S. L., Laetsch, T. W., Buechner, J., Rives, S., Boyer, M., Bittencourt, H., Bader, P., Verneris, M. R., Stefanski, H. E., Myers, G. D., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1709866 · Cited by 5,735
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Emerging new therapeutic antibody derivatives for cancer treatment
Jin, S., Sun, Y., Liang, X., Gu, X., Ning, J., Xu, Y., Chen, S., & Pan, L. (2022) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-021-00868-x · Cited by 459
Shah, N. N., Highfill, S. L., Shalabi, H., Yates, B., Jin, J., Wolters, P. L., Ombrello, A., Steinberg, S. M., Martin, S., Delbrook, C., et al. (2020) · Journal of Clinical Oncology · doi:10.1200/jco.19.03279 · Cited by 421
Metadata
- Authors
- von Stackelberg, A., Locatelli, F., Zugmaier, G., Handgretinger, R., Trippett, T. M., Rizzari, C., Bader, P., O’Brien, M. M., Brethon, B., Bhojwani, D., Schlegel, P. G., Borkhardt, A., Rheingold, S. R., Cooper, T. M., Zwaan, C. M., Barnette, P., Messina, C., Michel, G., DuBois, S. G., Hu, K., Zhu, M., Whitlock, J. A., & Gore, L.
- Venue
- Journal of Clinical Oncology
- Published
- 2016-12-20
- Volume
- 34
- Issue
- 36
- Pages
- 4381-4389
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2529226476
- Cited by
- 614
- References
- 26
- FWCI
- 54.11
- Type
- journal article
- Language
- en
- Open access
- green
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- von Stackelberg, A., Locatelli, F., Zugmaier, G., Handgretinger, R., Trippett, T. M., Rizzari, C., Bader, P., O’Brien, M. M., Brethon, B., Bhojwani, D., Schlegel, P. G., Borkhardt, A., Rheingold, S. R., Cooper, T. M., Zwaan, C. M., Barnette, P., Messina, C., Michel, G., DuBois, S. G., . . . Gore, L. (2016). Phase I/Phase II Study of Blinatumomab in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2016.67.3301
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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