Efficacy and Safety of APO866 in Patients With Refractory or Relapsed Cutaneous T-Cell Lymphoma: A Phase 2 Clinical Trial | Allergy and Clinical Immunology | JAMA Dermatology | JAMA Network
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Research Letter
July 2016

Efficacy and Safety of APO866 in Patients With Refractory or Relapsed Cutaneous T-Cell Lymphoma: A Phase 2 Clinical Trial

Author Affiliations
  • 1Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland
  • 2Private Practice, Feldmeilen, Switzerland
  • 3Department of Dermatology, Medical University of Graz, Graz, Austria
  • 4Department of Dermatology, University Medical Center Mannheim, University of Heidelberg, Heidelberg, Germany
  • 5Department of Dermatology, Nantes University Hospital, Nantes, France
  • 6Henri Mondor Hospital, Université Paris-Est Créteil Val de Marne (UPEC), Créteil, France
JAMA Dermatol. 2016;152(7):837-839. doi:10.1001/jamadermatol.2016.0401

For cutaneous T-cell lymphoma (CTCL),1 there is need for new treatment options. APO866 is an injectable molecule that induces cell death by inhibiting the biosynthesis of NAD+ (oxidized nicotinamide adenine dinucleotide), which is essential for cell survival.2-4 Previous studies have shown in vitro and in vivo that lymphocytes and hematologic cancer cells are very sensitive to APO866, which induced cell death at low concentration in various human tumor cells, including lymphomas.5

This open-label, single-arm, multicenter, phase 2 clinical trial took place from February 2007 to January 2011. We analyzed the efficacy (measured by objective response rates using the Tumor Burden Index [TBI]6 for cutaneous disease and imaging for extracutaneous disease), safety, and tolerability (using descriptive statistics) of APO866 in relapsed or refractory CTCL. APO866 (provided by Apoxis SA and later by Topotarget A/S) was administered every 28 days for a total of 3 cycles by continuous intravenous infusion via pump at 0.126 mg/m2/h over the course of 96 hours. The study was approved by the respective national and regional ethics committees and conducted according Good Clinical Practice guidelines (NCT00431912), and all participants provided their written informed consent.

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