Phase 1 multicenter trial of brentuximab vedotin for steroid-refractory acute graft-versus-host disease
Blood, ISSN: 0006-4971, Vol: 129, Issue: 24, Page: 3256-3261
2017
- 36Citations
- 54Captures
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Example: if you select the 1-year option for an article published in 2019 and a metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019. If you select the 3-year option for the same article published in 2019 and the metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019, 2018 and 2017.
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Metrics Details
- Citations36
- Citation Indexes36
- 36
- CrossRef31
- Captures54
- Readers54
- 54
Article Description
Therapy for steroid-refractory acute graft-versus-host disease (SR-aGVHD) remains suboptimal. Preclinical data demonstrate increased CD30 expression on activated CD8 + T cells during aGVHD. Brentuximab vedotin (BV) is an antibody-drug conjugate targeting CD30. We conducted a multicenter phase 1 trial in 34 patients to establish the maximum tolerated dose (MTD) of BV for SR-aGVHD treatment. A 3+3 cohort design was conducted initially with BV given weekly × 3 doses followed by maintenance dosing (initial dose 0.6 mg/kg IV weekly). Six patients were treated with the initial weekly dosing scheme; 2 of these patients died of neutropenic sepsis complications. The trial was subsequently revised to escalating cohorts of 5 patients treated every 2 weeks × 4 doses with a 4-week dose-limiting toxicity (DLT) period. Twenty-eight patients were treated with every-2-week dosing (n = 10 at 0.6 mg/kg; n = 18 at 0.8 mg/kg). MTD was defined at 0.8 mg/kg with 1 DLT observed (sepsis). At day 28, the overall response rate was 38.2% with 5 complete responses (CRs; 14.7%) and 8 very-good-partial responses (23.5%). An additional 7 patients achieved CR by day 56. With 12 months' follow-up on all patients, overall survival was 41% (95% confidence interval [CI], 25%-57%) at 6 months and 38% (95% CI, 22%-54%) at 12 months. CD30 expression on central memory CD8 +, central memory CD4 +, and regulatory T-lymphocyte subsets at enrollment was not associated with clinical response. BV is tolerable and has activity in SR-aGVHD and merits further investigation. This trial was registered at www.clinicaltrials.gov as #NCT01940796.
Bibliographic Details
http://www.sciencedirect.com/science/article/pii/S0006497120333073; http://dx.doi.org/10.1182/blood-2017-03-772210; http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85021183732&origin=inward; http://www.ncbi.nlm.nih.gov/pubmed/28473406; https://clinicaltrials.gov/ct2/show/NCT01940796; https://ashpublications.org/blood/article/129/24/3256/36282/Phase-1-multicenter-trial-of-brentuximab-vedotin; https://dx.doi.org/10.1182/blood-2017-03-772210
American Society of Hematology
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