The DOI matches its Crossref record; 25 of the 25 references it cites were found in a registry or an index.
Bispecific T-Cell Engager (BiTE) Antibody Construct Blinatumomab for the Treatment of Patients With Relapsed/Refractory Non-Hodgkin Lymphoma: Final Results From a Phase I Study
Abstract
Purpose: Blinatumomab is a CD19/CD3 BiTE (bispecific T-cell engager) antibody construct for the treatment of Philadelphia chromosome–negative acute B-lymphoblastic leukemia. We evaluated blinatumomab in relapsed/refractory B-cell non-Hodgkin lymphoma (NHL). Patients and Methods: This 3 + 3 design, phase I dose-escalation study determined adverse events and the maximum tolerated dose (MTD) of continuous intravenous infusion blinatumomab in patients with relapsed/refractory NHL. Blinatumomab was administered over 4 or 8 weeks at seven different dose levels (0.5 to 90 μg/m 2/day). End points were incidence of adverse events, pharmacokinetics, pharmacodynamics, and overall response rate. Results: Between 2004 and 2011, 76 heavily pretreated patients with relapsed/refractory NHL, who included 14 with diffuse large B-cell lymphoma, were enrolled; 42 received treatment in the formal dose-escalation phase. Neurologic events were dose limiting, and 60 μg/m 2/day was established as the MTD. Thirty-four additional patients were recruited to evaluate antilymphoma activity and strategies for mitigating neurologic events at a prespecified MTD. Stepwise dosing (5 to 60 μg/m 2/day) plus pentosan polysulfate SP54 (n = 3) resulted in no treatment discontinuations; single-step (n = 5) and double-step (n = 24) dosing entailed two and seven treatment discontinuations due to neurologic events, respectively. Grade 3 neurologic events occurred in 22% of patients (no grade 4/5). Among patients treated at 60 μg/m 2/day (target dose; n = 35), the overall response rate was 69% across NHL subtypes and 55% for diffuse large B-cell lymphoma (n = 11); median response duration was 404 days (95% CI, 207 to 1,129 days). Conclusion: In this phase I study of relapsed/refractory NHL, continuous infusion with CD19-targeted immunotherapy blinatumomab at various doses and schedules was feasible, with an MTD of 60 μg/m 2/day. Single-agent blinatumomab showed antilymphoma activity.
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Cites
Chimeric Antigen Receptor–Modified T Cells for Acute Lymphoid Leukemia
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Self-citationTumor Regression in Cancer Patients by Very Low Doses of a T Cell–Engaging Antibody
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Self-citationA Confidence Interval for the Median Survival Time
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Parker, K. R., Migliorini, D., Perkey, E., Yost, K. E., Bhaduri, A., Bagga, P., Haris, M., Wilson, N. E., Liu, F., Gabunia, K., et al. (2020) · Cell · doi:10.1016/j.cell.2020.08.022 · Cited by 455
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Tian, Z., Liu, M., Zhang, Y., & Wang, X. (2021) · Journal of Hematology & Oncology · doi:10.1186/s13045-021-01084-4 · Cited by 282
T-cell-engaging bispecific antibodies in cancer
van de Donk, N. W. C. J., & Zweegman, S. (2023) · The Lancet · doi:10.1016/s0140-6736(23)00521-4 · Cited by 267
Giffin, M. J., Cooke, K., Lobenhofer, E. K., Estrada, J., Zhan, J., Deegen, P., Thomas, M., Murawsky, C. M., Werner, J., Liu, S., et al. (2021) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-20-2845 · Cited by 258
Metadata
- Authors
- Goebeler, M.-E., Knop, S., Viardot, A., Kufer, P., Topp, M. S., Einsele, H., Noppeney, R., Hess, G., Kallert, S., Mackensen, A., Rupertus, K., Kanz, L., Libicher, M., Nagorsen, D., Zugmaier, G., Klinger, M., Wolf, A., Dorsch, B., Quednau, B. D., Schmidt, M., Scheele, J., Baeuerle, P. A., Leo, E., & Bargou, R. C.
- Venue
- Journal of Clinical Oncology
- Published
- 2016-04-01
- Volume
- 34
- Issue
- 10
- Pages
- 1104-1111
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2279127916
- Cited by
- 428
- References
- 25
- FWCI
- 38.30
- Type
- journal article
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: Bispecific T-Cell Engager (BiTE) Antibody Construct Blinatumomab for the Treatment of Patients With Relapsed/Refractory Non-Hodgkin Lymphoma: Final Results From a Phase I Study. https://app.cochat.ai/papers/10.1200/jco.2014.59.1586
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- Goebeler, M.-E., Knop, S., Viardot, A., Kufer, P., Topp, M. S., Einsele, H., Noppeney, R., Hess, G., Kallert, S., Mackensen, A., Rupertus, K., Kanz, L., Libicher, M., Nagorsen, D., Zugmaier, G., Klinger, M., Wolf, A., Dorsch, B., Quednau, B. D., . . . Bargou, R. C. (2016). Bispecific T-Cell Engager (BiTE) Antibody Construct Blinatumomab for the Treatment of Patients With Relapsed/Refractory Non-Hodgkin Lymphoma: Final Results From a Phase I Study. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2014.59.1586
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