"Lumiliximab"

A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed ch Lumiliximab is a chimeric monoclonal antibody that targets CD23 on the surface of chronic lymphocytic leukaemia (CLL) B-cells. Early phase clinical studies with lumiliximab alone and in combination with fludarabine, cyclophosphamide and rituximab (FCR) established its potential efficacy and tolerability. The 152CL201 trial [Lumiliximab with fludarabine, cyclophosphamide and rituximab (FCR) versus FCR alone in subjects with relapsed CLL; LUCID] was a phase 2/3, randomized (1:1), open-label, multicentre study of lumiliximab in combination

characteristic curve was generated to evaluate the accuracy. Both FcɛRI and CD23 were expressed on eosinophils. The expression of FcɛRI and CD23 on eosinophil in nasal polyp tissue was higher than that in peripheral blood (both P < 0.001). IgE and EPX co-localized in CRSwNP. IgE directly promoted eosinophil migration by upregulating CCR3 in CRSwNP but not in healthy controls. Omalizumab and lumiliximab were

centre series, patients were FCR naïve and received FC, FCR or FCR combined with lumiliximab, an anti‐CD23 antibody, at relapse leading to a median PFS of 20–30 months (Robak et al , ; Badoux et al , ; Awan et al , ). MDACC and French Collaborative groups included only patients with prior exposure to FCR (Tam et al , ; Fornecker et al , ). Treatment was more heterogenous [FCR, BR, alemtuzumab, CHOP‐R ) Neutropenia (≥ grade 3) Pneumonia (≥ grade 3) Furman et al ( ) Idelalisib + Rituximab 71 81% U 6 NR NR 34% 6% Rituximab + placebo 71 13% U 5·5 NR 22% 8% Chanan‐Khan et al ( ) BR + Ibrutinib 64 83% 10·4% 17 NR NR 54% 7% BR 63 68% 2·8% 13·3 NR 51% 1% Niederle et al ( ) BR 68 76% 27% 34 20·1 43·8 35% U FR 69 62% 9% 14·8 41·0 30% U Awan et al ( ) FCR + lumiliximab 61 72% 16% c Trial halted after 2nd interim

antibodies with immunomodulatory drugs (Lenalidomide), mAbs directed against other surface antigens such as CD22 and CD23 (Epratuzumab, Lumiliximab), immunomodulatory antibodies such as PD-1, or inhibitors of key steps in the B-cell receptor pathway signaling such as PI3K inhibitors (Idelalisib, Duvelisib). Another highly attractive approach is the application of the bi-specific T-cell engaging (BiTE

. Skoetz N, Bauer K, Elter T, Monsef I, Roloff V, Hallek M, et al. Alemtuzumab for patients with chronic lymphocytic leukaemia. Cochrane Database Syst Rev. 2012 Feb 15. CD008078. [QxMD MEDLINE Link]. [Full Text]. 40. Awan FT, Hillmen P, Hellmann A, Robak T, Hughes SG, Trone D, et al. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab

. Skoetz N, Bauer K, Elter T, Monsef I, Roloff V, Hallek M, et al. Alemtuzumab for patients with chronic lymphocytic leukaemia. Cochrane Database Syst Rev. 2012 Feb 15. CD008078. [QxMD MEDLINE Link]. [Full Text]. 40. Awan FT, Hillmen P, Hellmann A, Robak T, Hughes SG, Trone D, et al. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab

, and lumiliximab. Despite promising results in a phase I/II trial, a phase III trial comparing FCR with and without lumiliximab in patients with relapsed CLL was stopped early when an interim analysis failed to show sufficient efficacy of the combination of lumiliximab with FCR. [40] OfatumumabOfatumumab (Arzerra), an anti-CD20 monoclonal antibody, was approved by the US Food and Drug Administration (FDA . Skoetz N, Bauer K, Elter T, Monsef I, Roloff V, Hallek M, et al. Alemtuzumab for patients with chronic lymphocytic leukaemia. Cochrane Database Syst Rev. 2012 Feb 15. CD008078. [QxMD MEDLINE Link]. [Full Text]. 40. Awan FT, Hillmen P, Hellmann A, Robak T, Hughes SG, Trone D, et al. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab

, and lumiliximab. Despite promising results in a phase I/II trial, a phase III trial comparing FCR with and without lumiliximab in patients with relapsed CLL was stopped early when an interim analysis failed to show sufficient efficacy of the combination of lumiliximab with FCR. [40] OfatumumabOfatumumab (Arzerra), an anti-CD20 monoclonal antibody, was approved by the US Food and Drug Administration (FDA . Skoetz N, Bauer K, Elter T, Monsef I, Roloff V, Hallek M, et al. Alemtuzumab for patients with chronic lymphocytic leukaemia. Cochrane Database Syst Rev. 2012 Feb 15. CD008078. [QxMD MEDLINE Link]. [Full Text]. 40. Awan FT, Hillmen P, Hellmann A, Robak T, Hughes SG, Trone D, et al. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab

Anti-CD23 monoclonal antibody, lumiliximab, inhibited allergen-induced responses in antigen-presenting cells and T cells from atopic subjects. CD23 plays a role in the regulation of IgE production and allergy-induced immune and inflammatory responses. A novel anti-CD23 monoclonal antibody, lumiliximab, is a potential therapeutic antibody recently demonstrated to be safe in human beings . This study investigated the effects of lumiliximab on allergen-induced immune responses from atopic subjects compared with blocking HLA-DR and costimulatory molecules, CD80 and CD86. Allergen-stimulated PBMCs from atopic subjects were pretreated with lumiliximab or antibodies to CD80, CD86, and HLA-DR. Cultures were analyzed for cell proliferation and IL-1beta, TNF-alpha, and IL-5 cytokine secretion

(MAb) is a promising candidate therapy in allergic diseases. A newly developed agent known as Lumiliximab, which is an anti-CD23 MAb (Lumiliximab), was demonstrated to be a well-tolerated agent in a phase I clinical trial (a placebo-controlled study with allergic asthma). Adverse events were mild, and no relationship was apparent between the dose of Lumilixilab and the frequency, severity, or type

Phase 1/2 study of lumiliximab combined with fludarabine, cyclophosphamide, and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia. Preclinical data demonstrate enhanced antitumor effect when lumiliximab, an anti-CD23 monoclonal antibody, is combined with fludarabine or rituximab. Clinical data from a phase 1 trial with lumiliximab demonstrated an acceptable toxicity profile in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). We therefore pursued a phase 1/2 dose-escalation study of lumiliximab added to fludarabine, cyclophosphamide, and rituximab (FCR) in previously treated CLL patients. Thirty-one patients received either 375 mg/m(2) (n = 3) or 500 mg/m(2) (n = 28) of lumiliximab in combination with FCR for 6 cycles. The toxicity profile

Phase 1 study of lumiliximab with detailed pharmacokinetic and pharmacodynamic measurements in patients with relapsed or refractory chronic lymphocytic leukemia. Therapeutic antibodies have improved the outcome for patients with chronic lymphocytic leukemia (CLL). We conducted a phase 1, dose escalation and schedule optimization study of the primatized anti-CD23 antibody, lumiliximab , in patients with previously treated and refractory CLL. Forty-six patients were assigned sequentially to cohorts 1 through 6 and received lumiliximab at 125, 250, or 375 mg/m(2) weekly for 4 weeks; 500 mg/m(2) weekly for 4 weeks [500(A)]; 500 mg/m(2) thrice during week 1 then 500 mg/m(2) weekly for the next 3 weeks [500(B)]; or 500 mg/m(2) thrice a week for 4 weeks [500(C)], respectively. The median age

is under active study. Several investigational monoclonal antibodies are in preclinical or clinical studies, most notably lumiliximab (anti-CD23) and ofatumumab (HuMax CD20), and are briefly discussed in this review.

: lumiliximab Phase 1 Detailed Description: OBJECTIVES: * Determine a recommended phase II dose of IDEC-152 monoclonal antibody in patients with relapsed or recurrent chronic lymphocytic leukemia. * Determine the safety profile of this drug in these patients. * Determine the pharmacokinetics and pharmacodynamics of this drug in these patients. * Determine the efficacy of this drug

Lumiliximab in Combination With FCR in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)

Sponsors and Collaborators Biogen More InformationGo to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Publications: Byrd JC, O'Brien S, Flinn IW, Kipps TJ, Weiss M, Rai K, Lin TS, Woodworth J, Wynne D, Reid J, Molina A, Leigh B, Harris S. Phase 1 study of lumiliximab with detailed pharmacokinetic and pharmacodynamic measurements in patients with relapsed or refractory chronic lymphocytic leukemia. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4448-55. Pathan NI, Chu P, Hariharan K, Cheney C, Molina A, Byrd J. Mediation of apoptosis by and antitumor activity of lumiliximab in chronic lymphocytic leukemia cells and CD23+ lymphoma cell lines. Blood. 2008 Feb 1;111(3):1594-602. Epub 2007 Nov 21. Responsible Party

* CD23 * Gomiliximab * Lumiliximab