Open AccessTG1042 (Adenovirus-interferon-γ) in Primary Cutaneous B-cell Lymphomas: A Phase II Clinical Trial
Author(s) -
Brigitte Dréno,
Mirjana Urosevic-Maiwald,
Youn Kim,
Joan Guitart,
Madeleine Duvic,
O. 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
Publication year - 2014
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0083670
Subject(s) - medicine , context (archaeology) , adverse effect , phases of clinical research , gastroenterology , population , lymphoma , clinical trial , biology , paleontology , environmental health
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.gov NCT00394693