20 November, 2018
Single-use technology, designed for the manufacturing of biopharmaceutical products, has made major inroads over the last 30 years. First introduced in the late 1970s in the form of disposable capsules and a ...
A Phase II Study of Brentuximab Vedotin (BV) in the Treatment of Elderly Hodgkin Lymphoma (HL) Patients at First Relapse or With Primary Refractory Disease. (FIL BVHD01) (NCT02227433)
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in elderly patients at first relapse or with primary refractory HL.
In this trial, brentuximab vedotin will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of anti-cancer activity will be assessed using the revised response criteria for malignant lymphoma (Cheson et al. 2007).
Computed tomography (CT) scans (chest, neck, abdomen, and pelvis) will be performed at baseline and Cycles 4, 8, 12, and 16 and positron emission tomography (PET) scans will be done at baseline and Cycles 4, 8, 12 and 16. Patients will have an End of Treatment (EOT) assessment 30 ± 7 days after receiving their final dose of study drug. Long-term follow-up assessments (including survival and disease status information) will be performed every 12 weeks until either patient death or study closure, whichever occurs first. Patients who discontinue study treatment with stable disease or better will have CT scans done every 12 weeks until disease progression.
This trial is sponsored by Fondazione Italiana Linfomi ONLUS 
Last Editorial review: July 15, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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20 November, 2018
05 October, 2018
When the first antibody-drug conjugate (ADC) was approved by the U.S. Food and Drug Administration (FDA) in 2000, only a handful of patent applications claiming ADCs had been published. As research cont...