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

Br J Haematol. 2015 Jul;170(1):118-22. doi: 10.1111/bjh.13388. Epub 2015 Apr 1.

Abstract

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 (<30 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.

Trial registration: ClinicalTrials.gov NCT00381940.

Keywords: NF-κB; childhood haematological malignancies; clinical trials; paediatric oncology.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Boronic Acids / administration & dosage
  • Bortezomib
  • Child
  • Child, Preschool
  • Disease-Free Survival
  • Hodgkin Disease / drug therapy*
  • Humans
  • Ifosfamide / administration & dosage
  • Neoplasm Recurrence, Local / drug therapy
  • Pyrazines / administration & dosage
  • Vinblastine / administration & dosage
  • Vinblastine / analogs & derivatives
  • Vinorelbine
  • Young Adult

Substances

  • Boronic Acids
  • Pyrazines
  • Vinblastine
  • Bortezomib
  • Vinorelbine
  • Ifosfamide

Associated data

  • ClinicalTrials.gov/NCT00381940