A phase 2 study of bortezomib in combination with ifosfamide/vinorelbine in paediatric patients and young adults with refractory/recurrent Hodgkin lymphoma: a Children's Oncology Group study
Quality Assurance Review Center
Health Services Administration | Hematology | Neoplasms | Oncology | Pediatrics | Radiology
A Children's Oncology Group clinical trial aimed to determine if bortezomib (B) increased the efficacy of ifosfamide and vinorelbine (IV) in paediatric Hodgkin lymphoma (HL). This study enrolled 26 relapsed HL patients (years) treated with two to four cycles of IVB. The primary endpoint was anatomic complete response (CR) after two cycles. Secondary endpoints included overall response (OR: CR + partial response) at study completion compared to historical controls [72%; 95% confidence interval (CI): 59-83%]. Although few patients achieved the primary objective, OR with IVB improved to 83% (95% CI: 61-95%; p = 0.32). Although not statistically different, results suggest IVB may be a promising combination.
Rights and Permissions
Citation: Br J Haematol. 2015 Jul;170(1):118-22. doi: 10.1111/bjh.13388. Epub 2015 Apr 1. Link to article on publisher's site
Horton, Terzah M.; Drachtman, Richard A.; Chen, Lu; Cole, Peter D.; McCarten, Kathleen; Voss, Stephan; Guillerman, Robert P.; Buxton, Allen; Howard, Scott C.; Hogan, Shirley M.; Sheehan, Andrea M.; Lopez-Terrada, Dolores; Mrazek, Matthew D.; Agrawal, Neeraj; Wu, Meng-Fen; Liu, Hao; De Alarcon, Pedro A.; Trippet, Tanya M.; and Schwartz, Cindy L., "A phase 2 study of bortezomib in combination with ifosfamide/vinorelbine in paediatric patients and young adults with refractory/recurrent Hodgkin lymphoma: a Children's Oncology Group study" (2015). IROC Rhode Island (QARC) Publications. 9.