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 and Reinhard Dummer

PLOS ONE, 2014, vol. 9, issue 2, 1-6

Abstract: 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 5×1010 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.gov NCT00394693

Date: 2014
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0083670

DOI: 10.1371/journal.pone.0083670

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