Lumoxiti (moxetumomab pasudotox) / AstraZeneca 
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 29 Diseases   1 Trial   1 Trial   377 News 


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  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Rituxan (rituximab) / Roche
    Rituximab Reduces Immunogenicity and Increases Complete Remissions without Minimal Residual Disease in Relapsed/Refractory Hairy Cell Leukemia Patients Receiving Moxetumomab Pasudotox () -  Dec 7, 2024 - Abstract #ASH2024ASH_8826;    
    Patients 14-18 received the biosimilar Ruxience instead of rituximab...One multiply relapsed patient with rituximab allergy was treated off-protocol with 8 cycles of Moxe plus Obinutuzumab and achieved an MRD-free CR.Conclusions : MoxeR is a safe regimen for relapsed-refractory HCL/HCLv, with the highest MRD-free CR rate reported yet for this disease...Non-Hodgkin's lymphomas (NHL), such as diffuse large B-cell, mantle cell, marginal zone, follicular, and lymphoplasmacytic lymphoma, express significant levels of CD22, and lymphoma cells from these patients have sensitivity to Moxe similar to HCL. We believe this trial supports the testing of Moxe plus anti-CD20 Mab in patients with early HCL/HCLv, and in patients with NHL to convert MRD-positive to MRD-negative CRs.
  • ||||||||||  Rituxan (rituximab) / Roche
    A Randomized Phase 2 Trial of 2nd-Line Cladribine with Concurrent or Delayed Rituximab in Patients with Classic Hairy Cell Leukemia (Marriott Grand Ballroom 11-13 (Marriott Marquis San Diego Marina)) -  Nov 6, 2024 - Abstract #ASH2024ASH_2020;    
    Background : Hairy cell leukemia is a B-cell malignancy characterized by pancytopenia, splenomegaly, and long-term remissions to purine analogs cladribine (CDA) and pentostatin, but late relapses occur, presumably from minimal residual disease (MRD)...Two after CDAR vs 4 after CDA (p=0.42) progressed and required alternative therapy, several of whom remain MRD-free after moxetumomab pasudotox with rituximab...Thus, CDA with delayed rituximab at >6 months if/when blood becomes MRD-positive is still reasonable 2nd line treatment of HCL. Delayed rituximab is now being tested to eliminate MRD in patients who achieve MRD-positive CR to MEK +/- BRAF inhibition.
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
    Review, Journal:  Antibody-drug conjugate [ADC] treatment of leukaemia. (Pubmed Central) -  Jun 18, 2023   
    Three ADCs: Mylotarg, Besponda and Lumoxiti have improved overall survival and event=free survival as well as reduced relapse in 3 types of Leukaemia: AML, ALL and HCL, respectively. Lessons from these three SOC successful ADCs should guide other new ADCs in addressing the ADC-related off target toxicity due to the cytotoxic payload that limits their therapeutic index by using the successful approach of administrating lower doses in a fractionated regimen over time in separate days of the cycle to reduce the severity and frequency of the ADC-related serious toxicities that include ocular damage, long-term peripheral neuropathy and hepatic toxicity etc.
  • ||||||||||  Mekinist (trametinib) / Novartis
    MEK-KINASE INHIBITOR (TRAMETINIB) AS A TREATMENT OPTION FOR HAIRY CELL LEUKEMIA () -  May 12, 2023 - Abstract #EHA2023EHA_2872;    
    At the same time, the drug is effective in the absence of the MAP2K1 mutation (unlike vemurafenib, which effective only in the presence of the BRAFV600E mutation), and, like vemurafenib, trametinib monotherapy can be effective at a reduced dose (1 mg/day or 1 mg every other day). Kinase inhibitor, Treatment, MEK, Hairy cell leukemia
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate, Tafinlar (dabrafenib) / Novartis, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Review, Journal, IO biomarker:  Hairy Cell Leukemia: Where Are We in 2023? (Pubmed Central) -  Apr 25, 2023   
    Purine nucleoside analogs remain the cornerstone of treatment, and the addition of rituximab has deepened and prolonged responses in the upfront and relapsed setting...Future efforts will focus on identifying patients with high-risk disease who require intensified regimens. Multicenter collaborations are the key to improving overall survival and quality of life in this rare disease.
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca
    Trial termination:  PROXY: US Post-Marketing Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI) (clinicaltrials.gov) -  Apr 21, 2023   
    P=N/A,  N=2, Terminated, 
    Multicenter collaborations are the key to improving overall survival and quality of life in this rare disease. Recruiting --> Terminated; Study stopped due to lack of recruitment.
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate, Tecartus (brexucabtagene autoleucel) / Gilead
    ZUMA-25: Brexu-cel in Patients with R/R Rare B-cell Malignancies (Poster Area) -  Jan 24, 2023 - Abstract #EHAEBMTCART2023EHA_EBMT_CART_126;    
    P2
    The study will use a basket study design spanning 4 single-armed substudies with the following populations: i) R/R WM (n=60) after ≥2 prior lines of therapy that must have included a BTKi; ii) R/R RT DLBCL variant (n=60) after 1 line of therapy; iii) R/R BL (n=20) after 1 line of therapy; or iv) R/R HCL (n=20) after ≥2 lines of therapy including at least one purine nucleoside analog and moxetumomab pasudotox (if available)... ZUMA-25 is open and enrolling patients at clinical trial sites across North America and Europe (NCT05537766).
  • ||||||||||  Review, Journal:  Novel targeted treatments in hairy cell leukemia and other hairy cell-like disorders. (Pubmed Central) -  Jan 10, 2023   
    The BRAF mutation is missing in SDRPL and SBLPN: mitogen-activated protein kinase 1 (MAP2K1) mutations were found in 40% of SBLPN and VH4-34+ HCL patients, making possible to use MEK inhibitors (MEKi) such as trametinib, cobimetinib or binimetinib in monotherapy or associated with BRAFi...In this article, we will discuss the main mutations identified in HCL and HCL-like disorders and the signaling pathways potentially involved in the pathogenesis of the different hairy cell disorders. We will discuss the results of the recent clinical trials, which will help us to propose an algorithm useful in clinical practice and we will highlight the different new drugs that may be used in the near future.
  • ||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Rituximab As an Effective Salvage Therapy in Pretreated Hairy Cell Leukemia Patients: The Bologna Experience (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_3237;    
    Rituximab is an effective salvage therapy in pretreated HCL patients after failure of purine analogs, as it permits an adequate disease control with considerably long TTNT periods. It may be repeated if no alternatives are available, although it seems to reduce its efficacy in the following courses.
  • ||||||||||  Ruxience (rituximab-pvvr) / Pfizer, Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Rituxan (rituximab) / Roche
    Trial completion date, Trial primary completion date:  19-C-0042: Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia (clinicaltrials.gov) -  Oct 10, 2022   
    P1,  N=30, Recruiting, 
    The broad applicability suggests a cancer cell-specific vulnerability which, together with a cell-targeted arrest of protein synthesis by immunotoxins, generates a unique therapeutic window supporting clinical evaluation. Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2023 --> Jun 2024
  • ||||||||||  Polivy (polatuzumab vedotin-piiq) / Roche, Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Adcetris (brentuximab vedotin) / Takeda, Pfizer
    Trial completion, Adverse events:  Evaluation of Reporting of Antibody-Drug Conjugate Associated Sepsis-related Toxicities (clinicaltrials.gov) -  Jun 22, 2022   
    P=N/A,  N=24618, Completed, 
    No abstract available Recruiting --> Completed
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Journal:  Splicing-Mediated Antigen Escape from Immunotherapy for B-cell Malignancies. (Pubmed Central) -  May 6, 2022   
    Drug-resistant isoforms of CD22 exist within leukemic cells pretreatment and can influence response to the CD22-directed antibody-drug conjugate inotuzumab ozogamicin, the immunotoxin moxetumomab pasudotox, as well as anti-CD22 chimeric antigen receptor T cells. See related article by Zheng et al., p. 103 (7).
  • ||||||||||  Review, Journal, IO biomarker:  Advances in the Treatment of Hairy Cell Leukemia Variant. (Pubmed Central) -  Apr 30, 2022   
    Future directions include targeted therapies such as moxetumomab pasudotox, ibrutinib, trametinib, and binimetinib and potentially anti-CD22 chimeric antigen receptor T cell therapy. The purpose of this review is to provide an outline of the diagnostic approach and an update on the therapeutic advancements in HCL-V.
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca
    Enrollment change, Trial completion date, Trial primary completion date:  PROXY: US Post-Marketing Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI) (clinicaltrials.gov) -  Apr 20, 2022   
    P=N/A,  N=2, Recruiting, 
    The BTKi that are not yet approved are challenged by the new other targeted treatments. N=80 --> 2 | Trial completion date: Sep 2023 --> Dec 2023 | Trial primary completion date: Sep 2023 --> Dec 2023
  • ||||||||||  Journal:  How I treat refractory/relapsed hairy cell leukemia with BRAF inhibitors. (Pubmed Central) -  Apr 19, 2022   
    Hairy cell leukemia (HCL) responds very well to frontline chemotherapy with purine analogs (cladribine and pentostatine)...At progression, standard therapeutic options include a second course of purine analogs alone or in combination with rituximab and, upon second relapse, therapy with the anti-CD22 immunotoxin moxetumomab pasudotox...Other treatments explored in clinical trials are BTK inhibition with ibrutinib and co-inhibition of BRAF (through dabrafenib or vemurafenib) and its downstream target MEK (through trametinib or cobimetinib). Here, we focus on our experience with BRAF inhibitors in clinical trials and as off-label use in routine practice by presenting three challenging clinical cases to illustrate their management in the context of all available treatment options.
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Review, Journal, IO biomarker:  Hairy Cell Leukemia (HCL) and HCL Variant: Updates and Spotlights on Therapeutic Advances. (Pubmed Central) -  Apr 12, 2022   
    Good results were recently published and achieved with moxetumomab pasudotox (Moxe), an anti-CD22 immunoconjugate. In this review, we will present an update on HCL and HCL-V, focusing on pathophysiology and recent therapeutic advances.
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate
    Journal:  Moxetumomab pasudotox-Third line in Hairy cell leukemia (Pubmed Central) -  Feb 11, 2022   
    In this review, we will present an update on HCL and HCL-V, focusing on pathophysiology and recent therapeutic advances. No abstract available
  • ||||||||||  cladribine / Generic mfg.
    Review, Journal:  Diagnosis and treatment of hairy cell leukemia as the COVID-19 pandemic continues. (Pubmed Central) -  Jan 13, 2022   
    BRAF inhibitors and Ibrutinib can achieve remission, but due to persistence of MRD, must be used chronically to prevent relapse...Anti-CD22 recombinant immunotoxin moxetumomab pasudotox is FDA-approved in the relapsed setting and is unique in achieving high MRD-free CR rates as a single-agent. Avoiding chemotherapy and rituximab may be important in ensuring both recovery from COVID-19 and successful COVID-19 vaccination, an area of continued investigation.
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate, Elzonris (tagraxofusp) / Menarini, Nippon Shinyaku, Ontak (denileukin diftitox) / Eisai, TSD Japan
    Review, Journal:  Pseudomonas Exotoxin-Based Immunotoxins: Over Three Decades of Efforts on Targeting Cancer Cells With the Toxin. (Pubmed Central) -  Jan 4, 2022   
    Here, we will review these ITs to highlight the advances in PE-based anticancer strategies, as well as review the targeting moieties that are used to reduce the non-specific destruction of non-cancerous cells. Although we tried to be as comprehensive as possible, we have limited our review to those ITs that have proceeded to clinical trials and are still under active clinical evaluation.
  • ||||||||||  Ruxience (rituximab-pvvr) / Pfizer, Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Rituxan (rituximab) / Roche
    Trial completion date, Trial primary completion date:  19-C-0042: Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia (clinicaltrials.gov) -  Oct 26, 2021   
    P1,  N=20, Recruiting, 
    The novel model system of h/mCD22 lymphoma provides a unique platform to test targeted immunotherapies and may be amenable for other human B cell targets such as CD19 and CD20. Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2022 --> Jun 2023