Trial reportAnnals of hematology2019
Neurologic adverse events in patients with relapsed/refractory acute lymphoblastic leukemia treated with blinatumomab: management and mitigating factors.
Trial report in Annals of hematology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
52 citing papers in PubMed, 2 syntheses or guidelines pooled it, 104 citations in OpenAlex.
- Monitoring Neurocognitive Functioning After Pediatric Cellular Therapy or Hematopoietic Cell Transplant: Guidelines From the COG Neurocognition in Cellular Therapies Task Force.Transplantation and cellular therapy · 2022Guideline
- The safety of blinatumomab in pediatric patients with acute lymphoblastic leukemia: A systematic review and meta-analysis.Frontiers in pediatrics · 2022Pooled it
- Trial
- Phase 1b/2 study of blinatumomab in Japanese adults with relapsed/refractory acute lymphoblastic leukemia.Cancer science · 2020Trial
- Syndrome of inappropriate antidiuretic hormone secretion following immune effector cell-associated neurotoxicity syndrome during blinatumomab therapy: a case report.Journal of pharmaceutical health care and sciences · 2026Article
- Neurological adverse events of blinatumomab in children with B-cell acute lymphoblastic leukemia: a retrospective study.BMC pediatrics · 2026Article
- Landscape of T-cell bispecific antibodies in cancer therapy: therapeutic strategies, challenges and future prospection.Molecular cancer · 2026Review
- Monoclonal Antibodies as a Breakthrough in Personalised Leukaemia Therapy: What Pharmacists and Doctors Should Know.Pharmacy (Basel, Switzerland) · 2025Review
- The application of antibody-based agents in cancer therapy based on their mechanisms of action.Fundamental research · 2025Review
- Adverse events in the nervous system associated with blinatumomab: a real-world study.BMC medicine · 2025Article
- T-Cell redirecting bispecific antibodies: a review of a novel class of immuno-oncology for advanced prostate cancer.Cancer biology & therapy · 2024Review
- Review
- Molecular imaging supports the development of multispecific cancer antibodies.Nature reviews. Clinical oncology · 2024Review
- Cancer Therapy-Induced Encephalitis.Cancers · 2024Review
- Bispecific T-cell engagers in childhood B-acute lymphoblastic leukemia.Haematologica · 2024Review
- Stepping forward: T-cell redirecting bispecific antibodies in cancer therapy.Acta pharmaceutica Sinica. B · 2024Review
- Article
- Small-molecule-mediated control of the anti-tumour activity and off-tumour toxicity of a supramolecular bispecific T cell engager.Nature biomedical engineering · 2024Article
- T-Cell Engagers-The Structure and Functional Principle and Application in Hematological Malignancies.Cancers · 2024Review
- Revolutionizing cancer treatment: the power of bi- and tri-specific T-cell engagers in oncolytic virotherapy.Frontiers in immunology · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Neurologic events (NEs) have been reported during treatment with blinatumomab, a bispecific T cell engager (BiTE®) construct. We evaluated the occurrence, severity, and management of NEs; the relationship between NEs and blinatumomab dose; and the potential clinical risk factors in an open-label, single-arm, phase 2 study (N = 189). Patients had Philadelphia chromosome-negative, relapsed/refractory acute lymphoblastic leukemia (ALL) and ≥ 10% bone marrow blasts. The relationship between blinatumomab exposure and NE incidence and severity was assessed. Clinical risk factors for NEs were assessed in a post hoc multivariate analysis. Overall, 98 patients (52%) experienced NEs: most frequently, dizziness, tremor, confusional state, and encephalopathy. NEs occurred predominantly during cycle 1 (median onset, 9 days) and were usually grades 1 or 2. Grade ≥ 3 NEs (13-17% incidence), serious NEs (16-19% incidence), and recurring NEs were managed with infusion interruptions or dexamethasone treatment. The incidence of NEs increased with increasing blinatumomab exposure at a given dose, but exposure appeared unrelated to NE severity. NEs were more frequent in patients ≥ 65 years than < 65 years (72 vs 49%). In a multivariate analysis, race other than white (hazard ratio [HR], 2.11; P = 0.009), > 2 prior salvage therapies (HR, 2.48; P = 0.006), and prior NEs (HR, 1.65; P = 0.020) were risk factors for time to first on-study NE. Although the mechanism underlying NEs associated with blinatumomab treatment in patients with relapsed/refractory ALL remains unclear, NEs tended to occur early during treatment and were often resolved by interrupting treatment and with dexamethasone. Additional research is warranted to investigate the risk factors for NEs.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.