Objective: To review FDA approved and other potential uses of Ontak, denileukin diftitox. Methods: Information was obtained via the internet and a journal literature review. Results: In 1999, the FDA approved the use of denileukin diftitox for patients with persistent or relapsed CD25-positive cutaneous T-cell lymphoma (CTCL), but Ontak has been reported to be an effective therapy for other neoplastic and non-neoplastic conditions. Oncological uses include therapy for CD25-negative T-cell lymphoma, recurrent and refractory chronic lymphocytic leukemia (CLL), non-Hodgkin's B-cell lymphoma (NHL), and human T-cell lymphotropic virus- 1 (HTLV-1)-associated adult T-cell leukemia/lymphoma (ATL). Potential additional uses of Ontak include: therapy of graft-versus-host disease (GvHD) and autoimmune conditions, including psoriasis, rheumatoid arthritis (RA), systemic lupus, scleroderma and vasculitis. Denileukin diftitox's effect has also been studied for patients with hepatocellular carcinoma (HCC) and HIV, but c...

Denileukin diftitox: a novel immunotoxin.

Denileukindiftitox:anovel immunotoxin

6684 Background: Denileukin diftitox (DD), a recombinant fusion protein of diphtheria toxin linked to interleukin-2, is FDA approved for the tx of cutaneous T-cell NHL. Initial studies of DD included several heavily pretreated pts with B-cell NHL, and objective responses were observed. This phase II trial was designed to evaluate the response rate (RR) and toxicity of DD in pts with relapsed low grade B-cell NHL, and to evaluate RR by tumor interleukin-2 receptor (IL-2R) expression. Methods: Eligible patients were stratified into two arms: pts with >20% IL-2R expression (IL-2R+) or patients with <20% IL-2R expression (IL-2R-) with independent response assessment for each group. DD was dosed at 18μg/kg/d for 5 days every 21 days for 2 cycles. Responders continued therapy for up to six cycles. Steroid premedication was not allowed. Results: The study closed prematurely due to slow accrual. Thirty of 35 pts entered were eligible and underwent treatment (18 M, 12 F; 12 IL-2R+ and 18 IL-2R-). The median pt age...

Phase II study of denileukin diftitox for previously treated low grade non-Hodgkin’s lymphoma: E1497 final report

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Phase II study of denileukin diftitox for previously treated low grade non-Hodgkin’s lymphoma: E1497 final report