The first study of veltuzumab given IV weekly in NHL patients (IM-T-hA20-01) has shown excellent tolerability and even efficacy at weekly intravenous doses as low as 80-120 mg/m2 over 4 consecutive weeks. These clinical results confirm experiments laboratory studies. Laboratory studies using Veltuzumab administered subcutaneously showed potent activity based on B-cell depletion. The current studys goal is to determine if a subcutaneous (SC) dosing schedule of veltuzumab can be established in patients with NHL or ...
Find everything you need to know about Ofatumumab (Arzerra), including what it is used for, warnings, reviews, side effects, and interactions. Learn more about Ofatumumab (Arzerra) at EverydayHealth.com.
通用名】 ARZERRA 【英文名】ARZERRA(ofatumumab)Injection 【中文名】奥法木单抗ARZERRA 【生产厂家】 葛兰素史克公司 【规 格 .... ...
The treatment regimen consists of 2 elements. The first element is represented by one courses of veltuzumab (4 weekly injections of 200 mg/m2). 90Y-epratuzumab will be given as 2 injections at escalating doses 1 week apart and administered starting one week following the 4th veltuzumab injection.. After confirming eligibility and undergoing baseline assessments, the treatment starts with an imaging study using 111In-epratuzumab (5-mCi 111In-DOTA-epratuzumab co-infused with a total of 1.5 mg/kg unlabeled epratuzumab). Blood samples (~7 samples, 5 mL each) for pharmacokinetic analysis will be collected over 5-7 days, and patients will be imaged on 4 separate occasions (e.g., the day of injection (Day 0), Day 1, Day 3, 4, or 5, and day 6 or 7).. The patient will then initiate veltuzumab treatments starting 7 days after the 111In-epratuzumab injection. Veltuzumab is given in 4 weekly doses, each 200 mg/m2. A single blood sample will be taken before each veltuzumab dose to assess residual veltuzumab ...
I think the new pms-rituxan studies are exploring the possibility that the treatment failed because IV administration barely penetrates the cns. The assumption is that it works in rrms because the bbb is open and therefore the rituxan can get into the cns. I believe this logic is also part of the suitability criteria for hsct protocols...no relapses, no joy or something like that. The new studies all have an IT component. There is conflicting information out there regarding the usefulness of rituxan in the cns. Some claim the cns B cells arent cleared out by IT rituxan. Others claim they do. Based on successful use of IT rituxan for CNS lymphomas that were NOT managed by IV rituxan, I think the cns B cells are cleaned up by IT rituxan. Im not a doctor though...just a rampant speculator ...
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Treatment with the chimerical monoclonal antibody rituximab results in CD20-directed B cell depletion. Although this depletion is almost complete in the peripheral blood of nearly all patients with...
Ofatumumab is a human monoclonal antibody for the CD20 protein. Ofatumumab binds specifically to both the small and large extracellular loops of the CD20 molecule. The CD20 molecule is expressed on normal B lymphocytes (pre-B- to mature B-lymphocyte) and on B-cell CLL. The Fab domain of ofatumumab binds to the CD20 molecule and the Fc domain mediates immune effector functions to result in B-cell lysis in vitro. Ofatumumab received FDA approval on April 17, 2014, for use in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. Ofatumumab was also approved by Health Canada on August 13th, 2012.
After three months of Chemo, the Fludarabine/Mitoxantrone is really kicking his bone marrow but its not doing a whole lot to the cancerous lymphocytes, so the new plan is to add Rituxan. Rituxan is a monoclonal antibody which specifically targets mature B Lymphocytes (as opposed to ordinary chemo which kills a lot of "innocent bystander" cells.) This is good news, in my opinion - I was hoping they would try Rituxan soon. But of course, Rituxan has its own sticky wickets, and the first one comes up tomorrow when Dave gets his first dose of Rituxan ...
Patients with CD22(+) B-cell lymphomas will be treated with escalating doses as a 192 hr infusion of immunotoxin in a Phase I study to determine dose li
Monoclonal antibody therapy targeted therapy that can be used to treat colon cancer and other cancers. Find out about how it works and side effects.
The main purpose of this study is to examine how two separate groups of 17p deletion Chronic lymphocytic leukemia (CLL) participants respond to sequenti
The goal of this clinical research study is to learn if ofatumumab can help to control CLL/SLL that has not yet been treated. The safety of this drug will also be studied.
This month I had my first two infusions of Rituxan to treat my RRMS and I am wondering how long before I feel better? Should it be immediate - once the B cells are targeted/depleted? Or is there a delay ...
I know the side effects to look for while infusing Rituxan. My question is how does it effect the red count (H&H) after the infusion? Does it lower it as much as some other chemotherapy drugs or
Mouse Monoclonal Anti-CD45RB Antibody (BRA-11 (same as BRA-11G)) [DyLight 488]. B-Cell Marker. Validated: WB, ELISA, Flow, ICC/IF, IHC-Fr, IHC-P. Tested Reactivity: Human, Monkey (Negative). 100% Guaranteed.
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maybe its important to test and treat active infections before one starts rituximab and knocks out part of the immune system. active infections would...
Ռիտուքսիմաբը հայտնաբերվել է գիտնական Նաբիլ Հաննայի և նրա աշխատակիցների կողմից IDEC դեղագործական կազմակերպությունում IDEC-C2B8 անվան տակ։ Դեղի արտոնագիրը տրամադրվել է 1998-ին և վերջացել 2015թ-ին[39]։ Կլինիկական հետազոտություններում իր արդյունավետության և անվտանգության շնորհիվ[40], ռիտուքսիմաբը 1997թ-ին հաստատվեց սննդի և դեղերի վերահսկման կազմակերպության կողմից B բջջային ոչ-Հոջկինյան լիմֆոմաների՝ այլ քիմիոթերապիաների նկատմամբ կայուն ձևերի բուժման համար[41]։ Ռիտուքսիմաբը CHOP սխեմայի հետ միասին ավելի արդյունավետ է, քան CHOP սխեման առանձին տարածուն մեծ B բջջային ...
This open-label, randomized study will compare the efficacy of GDC-0199 plus rituximab (GDC-0199+R) with bendamustine plus MabThera/Rituxan (Rituximab) (B+R) in patients with relapsed or resistant chronic lymphocytic leukemia. Patients will be randomized 1:1 into the two arms. Patients randomized to GDC-0199+R will be given GDC-0199 daily (oral, target dose 400 mg) and will receive 6 cycles of rituximab infused intravenously (IV) on Day 1 of each 28-day cycle (Cycle 1: 375 mg/m2; Cycles 2-6: 500 mg/m2).. Patients randomized to B+R will receive 6 cycles of treatment consisting of a rituximab infusion (Cycle 1: 375 mg/m2; Cycles 2-6: 500 mg/m2) on Day 1 and bendamustine infusions (70 mg/m2) on Days 1 and 2 of each 28-day cycle.. Patients in the GDC-0199+R arm will continue GDC-0199 treatment until disease progression or 2 years since treatment start, whichever comes first. Anticipated time on study is up to 5 years.. ...
Paediatric onset multiple sclerosis (POMS) is characterized by high inflammatory activity. No disease modifying treatment has been approved for POMS. The objective of this report was to report the use of rituximab, a B cell depleting monoclonal anti-CD20-antibody, in POMS. This is a retrospective case series at four specialized MS centres in Sweden. Participants were identified through the Swedish MS-registry and our own patient stocks. Data were collected through medical charts review. We identified 14 POMS patients treated with i.v. rituximab 500-1000 mg every 6th to 12th months. Median age at disease onset was 14.7 years, median age at rituximab treatment initiation was 16.5 years, and median treatment duration was 23.6 months. No relapses were reported, and the EDSS scores remained stable or decreased in 13 of 14 cases during rituximab treatment. Beyond 6 months from initiating rituximab treatment, only one new lesion was detected on MRI. No serious AEs were reported. The drug survival was ...
WALTHAM, Mass., Nov. 6 /PRNewswire/ -- Decision Resources, one of the worlds leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that surveyed U.S. rheumatologists anticipate using Bristol-Myers Squibbs Orencia and Biogen Idec/Genentech/ Chugai/Zenyaku Kogyos Rituxan, also marketed as Roches MabThera, more frequently in first- and second-line biologic therapy through 2010 for the treatment of rheumatoid arthritis. "Currently, surveyed rheumatologists prescribe Orencia in earlier lines of therapy than Rituxan - 78 percent of them most commonly prescribe Orencia as a third-line biologic, whereas 51 percent of them use Rituxan as a fourth-line biologic," stated Madhuri Borde, Ph.D., analyst at Decision Resources. "Surveyed rheumatologists contend that physician familiarity, concern about the long-term effects of B-cell depletion with Rituxan and preference for Orencias mechanism of action influences physicians to prescribe Orencia instead of ...
Conclusions: Ofatumumab (up to 700 mg) given 2 weeks apart was not associated with any unexpected safety concerns and was well tolerated in patients with RRMS. MRI data suggest a clinically meaningful effect of ofatumumab for all doses studied. Results warrant further exploration of ofatumumab in RRMS. Classification of evidence: This study provides Class II evidence that in patients with RRMS, ofatumumab compared with placebo does not increase the number of serious adverse events and decreases the number of new MRI lesions. (Source: Neurology)
Monoclonal human IgG1 antibody against human CD20 Anti-hCD20-hIgG1 features the constant region of the human IgG1 isotype and the variable region of rituximab. Rituximab is a mouse/human chimeric monoclonal antibody that targets the CD20 antigen found on the surface of malignant and normal B lymphoc
Three patients enrolled in this study had non-follicular lymphoma histologies. One with small lymphocytic lymphoma achieved a complete response, currently ongoing now 72 weeks after treatment. The other 2 patients (one SLL, one MZL) entered with high levels of circulating B cells and failed to achieve an objective response. We have reported that in patients with chronic lymphocytic leukemia (CLL), the same subcutaneous doses and dosing schedule of veltuzumab used here also failed to achieve meaningful clinical benefit, but had evidence of pharmacological activity with transient decreases in the high levels of circulating leukemic B cells.32 For subcutaneous injections, more frequent or extended dosing or combination therapy with other agents will likely be required to overcome the higher antigen burden in these settings, consistent with the experience of other anti-CD20 antibodies which are given intravenously at much higher doses for patients with chronic lymphocytic leukemia.21. Compared to ...
The decline in the numbers of inflammatory cells and adhesion molecules in synovial tissue after CD4+ cell depletion supports the view that CD4+ T cells orchestrate local cellular infiltration. The lack of clinical effect of anti-CD4 therapy might be explained by an insufficient decrease in the numb …
Significant peripheral blood CD4+ T-cell depletion has been observed after a first cycle of rituximab, a monoclonal antibody directed against the CD20 antigen, which is currently used in rheumatoid arthritis. Of note, an absence of CD4+ T-cell decrease has been observed in non-responders. Herein, we describe CD4+ T-cell changes over repeated cycles of rituximab and their relationship with clinical outcomes.. METHODS ...
This study investigated the efficacy and tolerability of rituximab for the treatment of active rheumatoid arthritis in patients with incomplete B cell depletion
Summary Phase III Pivotal Study of Ofatumumab in Refractory CLL Meets Primary Endpoint Genmab A S (OMX GEN) and GlaxoSmithKline announced today positive top-lin
Chronic Lymphocytic Leukemia (CLL) - updated results of a phase III trial finds that idelalisib combined with ofatumumab is safe and effective in relapsed patients
1 Answer - Posted in: rituxan, skin, infusion - Answer: I develop raised hives, used lotion, ice, 2 Benadryl, hydrocortisone cream.
This phase II trial studies how well acalabrutinib, lenalidomide, and rituximab work in treating patients with CD20 positive stage III-IV, grade 1-3a...
Rituximab Helps in Sjgrens Syndrome By Nancy Walsh, Contributing Writer, MedPage Today Published: April 06, 2010 Reviewed by Dori F. Zaleznik, MD;...
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In the clinic, BCDT can markedly ameliorate the course of autoimmune diseases in patients, but the mechanisms underlying these beneficial effects are poorly understood, as they are thought, in many cases, to operate irrespective of autoantibody levels. Here, we demonstrate that IL-6 production is the major mechanism of B cell-mediated pathogenesis during EAE, and we show that this inflammatory pathway is markedly increased in RR-MS patients. Autoantibody levels were unaffected by IL-6 production by B cells. This is the first demonstration of a nonantibody-mediated mechanism of B cell pathogenesis in EAE and MS. Remarkably, the elevated production of IL-6 by B cells from MS patients was effectively normalized by Rituximab treatment. In both patients and mice the reduced disease severity after B cell depletion was accompanied by a decrease in the autoreactive Th17 response, and so we believe that B cells are making an all-important contribution to the IL-6-dependent promotion of pathogenic Th17 ...
Rituximab is an anti-CD20 monoclonal antibody frequently used for the treatment of non-Hodgkins lymphoma, chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), and anti-neutrophilic cytoplasmic antibody (ANCA)-associated vasculitis. In addition, rituximab has recently been increasingly used as an off-label treatment in a number of inflammatory and systemic autoimmune diseases. It is advised that rituximab infusion may cause infusion reactions and adverse cardiac effects including arrhythmia and angina, especially in patients with prior history of cardiovascular diseases. However, its detailed cardiotoxicity profile and effects on cardiac function were not well described. We report a 51-year-old man who developed non-ischemic cardiomyopathy after rituximab treatment for membranous nephropathy. The patient experienced reduced cardiac functions within 48 hours after the initial infusion, which remained markedly reduced at 9-month follow-up. As the utility of rituximab expands, physicians must be
BACKGROUND: The clinical and immunological relevance of a positive B-cell flow-cytometry (B-FCXM) crossmatch in renal transplantation is still controversial. METHODS: We retrospectively analysed 145 consecutive cadaveric renal transplantations performed from May 1991 to September 1995 in our institution. All grafts were transplanted following a negative IgG T-cell complement-dependent cytotoxicity crossmatch (T-CDCXM). Concomitantly to CDCXM, B-cell and T-cell FCXM were performed and results were expressed as a mean fluorescence index (FI). Two groups were compared: 116 recipients grafted with a negative B-FCXM vs a group of 19 patients grafted with a positive B-FCXM. RESULTS: The two groups were similar for length of cold ischaemia, donor and recipients age and degree of HLA mismatching. The proportion of patients with pre-transplant anti-HLA class I antibodies or a retransplantation was significantly increased in the positive B-FCXM group vs the negative B-FCXM group. Recipient survival at 48 ...
What is the mechanism of action? Tositumomab and I131 tositumomab is a type of agent called a radioimmunotherapeutic. It is comprised of two different portions: a monoclonal antibody designed to recognize a specific target (tositumomab) and a radioactive isotope as a source of radiation (I131). The monoclonal antibody portion has been developed through laboratory processes to bind to B-cells which comprise the majority of cancerous cells in non-Hodgkins lymphoma. It is thought that this binding action stimulates the immune system to attack the cancer cells. In addition, the radioisotope that is attached to the monoclonal antibody emits radiation, killing the cancer cells in a second manner.. How is tositumomab given (administered)? Tositumomab and I131 tositumomab are administered into a vein (intravenous). The regimen is administered in two steps; the dosimetric step, in which the therapeutic dose is determined, and the therapeutic step, where the patient actually receives the dose for ...
The present study provides evidence demonstrating that chemoresistance and Fas resistance in B-NHL cell lines are commonly regulated by constitutive NF-κB activation. However, downstream of NF-κB, chemoresistance and Fas resistance are differentially regulated by Bcl-xL and YY1, respectively. Rituximab-mediated inhibition of NF-κB activity resulted in both the inhibition of Bcl-xL expression and chemosensitization and the inhibition of the transcription repressor YY1 and sensitization to CH-11-induced apoptosis. These differentially regulated mechanisms for chemo- and CH-11-induced apoptosis emanated from findings making use of both biologically engineered cell lines and specific chemical inhibitors. Treatment with rituximab or specific inhibitors of NF-κB sensitized NHL cells to both drug- and CH-11-induced apoptosis. The role of Bcl-xL expression in the regulation of drug resistance, but not Fas resistance, was demonstrated by the failure of rituximab to sensitize Bcl-xL-overexpressing ...
We thank Dr Wallace et al for their response to our recently published article Trimethoprim-sulfamethoxazole prophylaxis prevents severe/life-threatening infections following rituximab in antineutrophil cytoplasm antibody-associated vasculitis, highlighting some methodological limitations of our study.1 2 One of the limitations mentioned by Wallace and colleagues is the inclusion of incident and prevalent cases and since only 15 out of 192 patients were incident cases, generalisability of our findings for this subset of patients may not be possible. We agree that the use of immunosuppression prior to initiation of rituximab likely confers a risk to develop infectious complications after rituximab administration. Cyclophosphamide was used to control disease in 62 patients the year before rituximab was initiated. Among these, 53 patients had no severe infection (median cyclophosphamide exposure 7 g, range 0.66-45 g), while 9 patients receiving cyclophosphamide the index year before had a severe ...
This meta-analysis showed that patients receiving chemotherapy plus rituximab benefit in terms of OS as well as PFS compared to those with chemotherapy alone. Therefore, it supports the recommendation of rituximab in combination with FluC as an option for the first-line treatment as well as for the …
... Summary: Phase III Pivotal Study of Ofatumumab in Refractory CLL Me... Primary Endpoint ...COPENHAGEN July 31 /- Genmab A/S (OMX: GEN) an...The activity of ofatumumab was evaluated in 154 patients in thisinter...,Genmab,and,GlaxoSmithKline,Announce,Positive,Top-Line,Results,in,Ofatumumab,Chronic,Lymphocytic,Leukemia,Pivotal,Study,medicine,advanced medical technology,medical laboratory technology,medical device technology,latest medical technology,Health
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Results. In patients with pSS, frequencies of circulating TFH cells and Th17 cells were increased at baseline compared with HC, whereas frequencies of Th1 and Th2 cells were unchanged. B cell depletion therapy resulted in a pronounced decrease in circulating TFH cells, whereas Th17 cells were only slightly lowered. Frequencies of IL-21-producing and IL-17-producing CD4+ T cells and serum levels of IL-21 and IL-17 were also reduced. Importantly, the decrease in circulating TFH cells was associated with lower systemic disease activity over time, as measured by the European League Against Rheumatism Sjögrens Syndrome Disease Activity Index scores and serum IgG levels. ...
Most adverse experiences (AEs) were transient grade 1 or 2 events occurring during the treatment period. Clinically significant myelosuppression was not observed; hematologic toxicity was generally mild and reversible. No patient developed human antichimeric antibodies after treatment. The type, frequency, and severity of AEs in this study were not apparently different from those reported in the phase III trial of rituximab. The overall response rate in 57 assessable patients was 40% (11% complete response and 30% partial responses). Median time to progression (TTP) in responders and median duration of response (DR) have not been reached, but Kaplan-Meier estimated medians are 17.8 months (range, 5.4+ to 26.6 months) and 16.3 months (range, 3.7+ to 25.1 months), respectively. These estimated medians are longer than the medians achieved in the patients prior course of rituximab (TTP and DR of 12.4 and 9.8 months, respectively, P: ,.1) and in a previously reported phase III trial (TTP in ...
This trial is investigating the pharmacokinetics, efficacy and tolerability of bendamustine + ofatumumab versus ofatumumab in patients with previously untreated
Contraindications: Patients should not become pregnant while undergoing tositumomab therapy and therapy should not be given before pregnancy is ruled out. Contraception should be used by males and females during and 12 months after treatment has ended. Patients who have already received murine proteins and may have mounted an anti-mouse immune response are at a higher risk for a reaction of this sort. In some patients hypothyroidism (reduced thyroid gland function) may occur. For this reason thyroid blocking agents must be administered with tositumomab. Treatment and screening for hypothyroidism should continue on an annual basis after treatment ends. Because this therapy includes a radioactive material that is inside the body for some period of time, patients should be given special instructions and precautions to prevent harm to any other person.1. ...