PLoS ONE (Jan 2014)

TG1042 (Adenovirus-interferon-γ) in primary cutaneous B-cell lymphomas: a phase II clinical trial.

  • Brigitte Dreno,
  • Mirjana Urosevic-Maiwald,
  • Youn Kim,
  • Joan Guitart,
  • Madeleine Duvic,
  • Olivier Dereure,
  • Amir Khammari,
  • Anne-Chantal Knol,
  • Anna Derbij,
  • Monika Lusky,
  • Isabelle Didillon,
  • Anne-Marie Santoni,
  • Bruce Acres,
  • Vincent Bataille,
  • Marie-Pierre Chenard,
  • Pascal Bleuzen,
  • Jean-Marc Limacher,
  • Reinhard Dummer

DOI
https://doi.org/10.1371/journal.pone.0083670
Journal volume & issue
Vol. 9, no. 2
p. e83670

Abstract

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RATIONAL:While a variety of registered therapies exist for Cutaneous T Cell Lymphoma, no such therapy is available for Cutaneous B Cell Therapy. In this context we performed a phase II, open label, multicenter, non-comparative study to evaluate the efficacy and safety of repeated intra-lesional administrations of TG1042 (adenovirus-interferon-γ) in patients with relapsing primary cutaneous B-cell lymphomas (CBCL). METHOD:Thirteen patients have been enrolled and received intralesional injections of TG1042 containing 5×10(10) viral particles into up to six lesions simultaneously. Injections were performed on days 1, 8 and 15 of each of four consecutive 28 day cycles. RESULTS:Eleven (85%) out of 13 enrolled patients showed an objective response after injections of TG1042. Seven patients (54%) exhibited complete and four (31%) displayed partial response. The median time to disease progression in the study population was 23.5 months (range 6.25 to 26+). Most commonly observed adverse events were minor to moderate flu-like symptoms, fatigue and injection site reactions. CONCLUSIONS:Our study showed that treatment with TG1042 was associated with a clinical benefit in the majority of the patients with relapsing CBCL, including tumor regression, a clinically meaningful duration of response and a good treatment tolerance. TRIAL REGISTRATION:www.clinicaltrials.govNCT00394693.