This phase I/II trial tests the safety, side effects, and best dose of tazemetostat and umbralisib and whether tazemetostat in combination with umbralisib and ublituximab works to shrink tumors in patients with follicular lymphoma that has come back (relapsed) or does not respond to treatment (refractor). Tazemetostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Umbralisib may help block the formation of growths that may become cancer. Ublituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving tazemetostat in combination with umbralisib and ublituximab may work better in treating follicular lymphoma.

Start Date01 May 2023

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT04635683

/ WithdrawnPhase 1IIT

A Phase I Trial of Lenalidomide, Umbralisib and Ublituximab in Patients With Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma

This phase I trial studies the safety and how effective the combination of ublituximab, umbralisib, and lenalidomide is in certain types of indolent (slow-growing) non-Hodgkin's lymphoma or mantle cell lymphoma. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide may also stop the growth of non-Hodgkin's lymphoma by blocking blood flow to the cancer. Umbralisib is designed to block a protein called PI3 kinase in order to stop cancer growth and cause changes in the immune system that may allow the immune system to better act against cancer cells. Ublituximab is an antibody that attaches to the lymphoma cells and triggers immune reactions that may result in the death of the targeted lymphoma cells.

Start Date30 Sep 2022

Sponsor / Collaborator

Ohio State University Comprehensive Cancer Center

NCT04692155

/ TerminatedPhase 1/2IIT

Phase Ib/II Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL)

This is a single arm, multi-center, open label Phase Ib/II trial in adult patients with newly diagnosed Mantle Cell Lymphoma (MCL)(Stage II-IV). The Diagnosis of MCL (Stage II, III, IV) is supported by histology and over expression of cyclin D1 or by FISH (fluorescent in situ hybridization). In the proposed study, the primary endpoint is to estimate the biological response rate of the combination of Umbralisib at dose 800 mg with Ublituximab (900mg)-Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (CHOP), but a phase Ib portion with dose de-escalation at two does level (800 and 600 mg) will be built in to further confirm its safety and tolerability. Treatment will be administered on an outpatient basis in 3-week (21 day) cycles. Once Umbralisib dose is defined in phase Ib, the study will expand to phase II portion after SMC/DSMB (Safety monitoring committee/Data Safety Monitoring Committee) agreement.

Start Date31 Aug 2021

Sponsor / Collaborator

The University of Alabama at Birmingham

100 Clinical Results associated with Umbralisib Tosylate

100 Translational Medicine associated with Umbralisib Tosylate

100 Patents (Medical) associated with Umbralisib Tosylate

117

Literatures (Medical) associated with Umbralisib Tosylate

05 Jan 2025·Journal of Computational Chemistry

Development of a machine learning‐based target‐specific scoring function for structure‐based binding affinity prediction for human dihydroorotate dehydrogenase inhibitors

Article

Author: He, Zhe ; Zhang, Li ; Tian, Qifeng ; Bao, Wenzhuo ; Feng, Huawei ; Liu, Hongsheng ; Liu, Jinhan ; Hu, Mengfeng ; Meng, Jinhui

AbstractHuman dihydroorotate dehydrogenase (hDHODH) is a flavin mononucleotide‐dependent enzyme that can limit de novo pyrimidine synthesis, making it a therapeutic target for diseases such as autoimmune disorders and cancer. In this study, using the docking structures of complexes generated by AutoDock Vina, we integrate interaction features and ligand features, and employ support vector regression to develop a target‐specific scoring function for hDHODH (TSSF‐hDHODH). The Pearson correlation coefficient values of TSSF‐hDHODH in the cross‐validation and external validation are 0.86 and 0.74, respectively, both of which are far superior to those of classic scoring function AutoDock Vina and random forest (RF) based generic scoring function RF‐Score. TSSF‐hDHODH is further used for the virtual screening of potential inhibitors in the FDA‐Approved & Pharmacopeia Drug Library. In conjunction with the results from molecular dynamics simulations, crizotinib is identified as a candidate for subsequent structural optimization. This study can be useful for the discovery of hDHODH inhibitors and the development of scoring functions for additional targets.

01 Jan 2025·HemaSphere

Long‐term results of a phase 1/1b study of ibrutinib plus umbralisib for relapsed/refractory chronic lymphocytic leukemia

Article

Author: Sportelli, Peter ; Ryan, Christine E. ; Boruchov, Adam M. ; Brown, Jennifer R. ; Miskin, Hari ; Tyekucheva, Svitlana ; Arnason, Jon E. ; Davids, Matthew S. ; Ren, Yue ; Fisher, David C. ; Jacobson, Caron A.

01 Dec 2024·Computational and Structural Biotechnology Journal

Uncovering the potential of APOD as a biomarker in gastric cancer: A retrospective and multi-center study

Article

Author: Wang, Xuanyu ; Sun, Le ; Tian, Sufang ; Liu, Xiaoping ; Xu, Yihang ; Chen, Hongshan ; Wang, Zisong

Gastric cancer (GC) poses a significant health challenge worldwide, necessitating the identification of predictive biomarkers to improve prognosis. Dysregulated lipid metabolism is a well-recognized hallmark of tumorigenesis, prompting investigation into apolipoproteins (APOs). In this study, we focused on apolipoprotein D (APOD) following comprehensive analyses of APOs in pan-cancer. Utilizing data from the TCGA-STAD and GSE62254 cohorts, we elucidated associations between APOD expression and multiple facets of GC, including prognosis, tumor microenvironment (TME), cancer biomarkers, mutations, and immunotherapy response, and identified potential anti-GC drugs. Single-cell analyses and immunohistochemical staining confirmed APOD expression in fibroblasts within the GC microenvironment. Additionally, we independently validated the prognostic significance of APOD in the ZN-GC cohort. Our comprehensive analyses revealed that high APOD expression in GC patients was notably associated with unfavorable clinical outcomes, reduced microsatellite instability and tumor mutation burden, alterations in the TME, and diminished response to immunotherapy. These findings provide valuable insights into the potential prognostic and therapeutic implications of APOD in GC.

News (Medical) associated with Umbralisib Tosylate

06 Dec 2024

·www.biospace.com

FDA Outlines Accelerated Review Guidelines in Waning Days of Biden Administration

iStock, SvetaZi The program has recently become controversial as a number of high-pro approvals were granted only for the drugs to fail a confirmatory trial later on. Now, the FDA has clearly laid out expectations. As the Biden administration winds down, the FDA is setting out guidance on its current thinking around accelerated approvals, an issue that rose to the top of Commissioner Robert Califf’s to-do list amid a flurry of controversy around a handful of such drug approvals. Accelerated approvals are granted to drugs that address an unmet medical need for serious or life-threatening conditions. Sponsors can get a drug approved based on a surrogate endpoint such as a biomarker that is reasonably likely to predict clinical benefit. They must also conduct a confirmatory trial to turn the accelerated approval into a regular approval. The program has been around for decades, but has recently become controversial as a number of high-pro approvals were granted, only for the drugs to fail a confirmatory trial later on. During his tenure, Califf has overseen some changes to the accelerated review program. He set out the expectation that drug sponsors must have the confirmatory trial underway at the time of accelerated approval, or at least have a plan to get one started swiftly. That directive is codified in the new guidance, although the document is nonbinding. The guidance also says that the label for the drug will include “a succinct description of the limitations of usefulness of the drug and any uncertainty about anticipated clinical benefits.” If an adequate and well-controlled trial cannot be conducted, accelerated approval should not be considered, the guidance explains. The FDA also defines surrogate endpoints and provides examples of recent ones that have been used to support an accelerated approval, such as a decrease in iron stores for patients with iron overload caused by beta thalassemia. The agency also recommends that sponsors intending to seek accelerated approval start regulatory conversations early in the drug development process to gain alignment with the FDA on a surrogate endpoint. These conversations can occur as soon as at the end of Phase I. Once accelerated approval is granted, sponsors must conduct their confirmatory trial “with due diligence,” the guidance explains. The proposed trial protocol should be submitted to the FDA for review as early as possible, with trial timelines clearly explained. Going forward, the FDA intends to require that these trials be underway before an accelerated approval is granted except in very limited circumstances , the guidance explains. These trials should stick close to the intended population that is already able to access treatment and can even be an extended duration of the trial that was used to support the accelerated approval. In some cases, the FDA can withdraw an accelerated approval if certain conditions aren’t met. The guidance gives examples such as the sponsor failing to conduct the confirmatory trial with due diligence, the study failing to confirm clinical benefit, safety concernsand the sponsor disseminating false or misleading promotional materials about the product. If a withdrawal is considered, the FDA center that approved the drug should convene an advisory committee meeting. This will allow a robust public discussion and give the sponsor an opportunity to provide evidence and data. The FDA has rarely stepped in to request withdrawals of high pro even those that fail confirmatory trials, leaving the decision up to the sponsor. For example, Pfizer recently withdrew the sickle cell disease drug Oxbryta from the market and ended ongoing clinical trials voluntarily after evidence suggested a higher risk of death and complications in treated patients. The drug received accelerated approval in November 2019. By contrast, Elevidys, a Duchenne muscular dystrophy gene therapy by Sarepta Therapeutics, failed a confirmatory trial last year and the company opted to keep it on the market, eventually securing full approval and a label expansion, though questions remain about the treatments’ efficacy. However, in June 2022 the FDA did withdraw an advanced nod for TG Therapeutics’ lymphoma drug Ukoniq after it showed a possible increased risk of death. The above graphic was created as part of a special edition of our ClinicaSpace newsletter sent out last month to subscribers only. To get a copy, subscribe here !

Accelerated ApprovalGene Therapy

19 Sep 2024

·www.prnewswire.com

Mantle Cell Lymphoma Clinical Trial Pipeline Insights Featuring 20+ Companies | DelveInsight

Mantle cell lymphoma is a rare and aggressive type of non-Hodgkin lymphoma originating from B-cells in the "mantle zone" of the lymph nodes. The development of novel targeted therapies and immunotherapies, such as Bruton's tyrosine kinase (BTK) inhibitors, is improving treatment outcomes and driving market growth for Mantle cell lymphoma. LAS VEGAS, Sept. 19, 2024 /PRNewswire/ -- DelveInsight's ' Mantle Cell Lymphoma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline mantle cell lymphoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the mantle cell lymphoma pipeline domain. Key Takeaways from the Mantle Cell Lymphoma Pipeline Report DelveInsight's mantle cell lymphoma pipeline report depicts a robust space with 20+ active players working to develop 22+ pipeline therapies for mantle cell lymphoma treatment. Key mantle cell lymphoma companies such as AbbVie, Adicet Bio, InnoCare Pharma Inc., Guangzhou Lupeng Pharmaceutical Company LTD., BeiGene, Nurix, LegoChem Biosciences, Xynomic Pharmaceuticals, Merck & Co, Incyte Corporation, TG Therapeutics, Janssen/Pharmacyclics, Eternity Bioscience, Traws Pharm, Advenchen Laboratories, and others are evaluating new mantle cell lymphoma drugs to improve the treatment landscape. Promising mantle cell lymphoma pipeline therapies such as Venetoclax, ADI-001, Orelabrutinib, LP-168, BGB-11417, NX 2127, LCB 71, NX 5948, Abexinostat, Pembrolizumab, Parsaclisib, Umbralisib, Ibrutinib, Edralbrutinib, Narazaciclib, Lucitanib, and others are under different phases of mantle cell lymphoma clinical trials. In May 2024, AstraZeneca had announced positive interim results from the Phase III ECHO clinical trial, which evaluated Bruton's tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) in combination with standard chemoimmunotherapy for treating mantle cell lymphoma (MCL). In March 2024, BeiGene, Ltd. announced the presentation of emerging oncology pipeline data at the American Association for Cancer Research (AACR) Annual Meeting. Additional highlights include preclinical characterization data for an investigational BTK degrader, BGB-16673, currently in clinical development for B-cell malignancies, including mantle cell lymphoma In October 2023, Ascentage Pharma announced that it has entered into a clinical collaboration with AstraZeneca Investment. The two companies will jointly conduct a registrational Phase III study of the Bcl-2 inhibitor, APG-2575 (lisaftoclax), in combination with AstraZeneca's Bruton's tyrosine kinase (BTK) inhibitor, CALQUENCE® (acalabrutinib), in treatment-naive patients with first-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). In January 2023, the FDA granted an orphan drug designation to LP-284, a novel small-molecule, next-generation acylfulvene, for the treatment of mantle cell lymphoma (MCL), a rare and aggressive form of B-cell non-Hodgkin lymphoma (NHL), according to an announcement from Lantern Pharma. Request a sample and discover the recent advances in mantle cell lymphoma treatment drugs @ Mantle Cell Lymphoma Pipeline Report The mantle cell lymphoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage mantle cell lymphoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the mantle cell lymphoma clinical trial landscape. Mantle Cell Lymphoma Overview Mantle cell lymphoma (MCL) is a rare subtype of B-cell non-Hodgkin lymphomas (NHLs) characterized by the (11,14) translocation, leading to overexpression of the cyclin D1 (CCND1) gene. Its various morphological variants can make diagnosis challenging, though some cases are straightforward. Many individuals with MCL are asymptomatic in the early stages, but may later seek medical attention due to persistent, typically painless swelling of lymph nodes, especially in the neck and throat region (e.g., Waldeyer's ring). MCL is marked by a reciprocal chromosomal translocation t(11;14)(q13;q32), which places the cyclin D1 gene next to the immunoglobulin heavy chain gene, causing continuous cyclin D1 expression. This overexpression contributes to tumor cell proliferation through cell cycle dysregulation, chromosomal instability, and epigenetic changes. Rarely, MCL cases without this translocation may involve CCND2 or CCND3 translocations. Hypothetical molecular subtypes, based on the cell of origin, correlate with clinical phenotypes: classical or aggressive MCL arises from naive B cells lacking or having limited iGVH mutations and expressing SOX11, a neural transcription factor inhibiting terminal B cell differentiation. The indolent variant originates from antigen-experienced B cells with IGVH somatic hypermutations, typically SOX11-negative and genetically stable. Diagnosis of MCL involves detailed patient history, thorough clinical evaluation, and specialized tests, including biopsy of an affected lymph node or bone marrow. These tests confirm the NHL type and subtype, assess disease extent, and determine appropriate treatments. Treatment for MCL is multifaceted and tailored to each patient, often including chemotherapy, immunotherapy drugs like rituximab, targeted therapies such as ibrutinib, and stem cell transplants, particularly for aggressive disease or younger patients. Radiation therapy may target specific lymphoma areas. Participation in clinical trials can offer new treatment options. Treatment plans are developed collaboratively by healthcare professionals and patients, considering disease stage, overall health, and personal preferences. Regular monitoring and follow-up care are essential to track treatment response and manage side effects effectively. Find out more about mantle cell lymphoma treatment drugs @ Drugs for Mantle Cell Lymphoma Treatment A snapshot of the Mantle Cell Lymphoma Pipeline Drugs mentioned in the report: Learn more about the emerging mantle cell lymphoma pipeline therapies @ Mantle Cell Lymphoma Clinical Trials Mantle Cell Lymphoma Therapeutics Assessment The mantle cell lymphoma pipeline report proffers an integral view of the mantle cell lymphoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Mantle Cell Lymphoma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Apoptosis stimulants, Proto-oncogene protein c-bcl-2 inhibitors, Proteasome inhibitors, Immunologic cytotoxicity, T lymphocyte replacements, Agammaglobulinemia tyrosine kinase inhibitors Key Mantle Cell Lymphoma Companies: AbbVie, Adicet Bio, InnoCare Pharma Inc., Guangzhou Lupeng Pharmaceutical Company LTD., BeiGene, Nurix, LegoChem Biosciences, Xynomic Pharmaceuticals, Merck & Co, Incyte Corporation, TG Therapeutics, Janssen/Pharmacyclics, Eternity Bioscience, Traws Pharm, Advenchen Laboratories, and others Key Mantle Cell Lymphoma Pipeline Therapies: Venetoclax, ADI-001, Orelabrutinib, LP-168, BGB-11417, NX 2127, LCB 71, NX 5948, Abexinostat, Pembrolizumab, Parsaclisib, Umbralisib, Ibrutinib, Edralbrutinib, Narazaciclib, Lucitanib, and others Dive deep into rich insights for new drugs for mantle cell lymphoma treatment, visit @ Mantle Cell Lymphoma Drugs Table of Contents For further information on the mantle cell lymphoma pipeline therapeutics, reach out @ Mantle Cell Lymphoma Treatment Drugs Related Reports B-Cell Lymphoma Epidemiology B-Cell Lymphoma Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the B-cell lymphoma epidemiology trends. B-Cell Lymphoma Market B-Cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key B-cell lymphoma companies, including Vincerx Pharma, Ubix Therapeutics, Biomea Fusion Inc, Shanghai Hengrui Pharmaceutical, BeiGene, Hanmi Pharmaceutical, among others. Diffuse Large B-Cell Lymphoma Pipeline Diffuse Large B-Cell Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key DLBCL companies, including Genmab, Roche, Acerta Pharma, Autolus, Xynomic Pharmaceuticals, Genentech, Celgene, AbbVie, Mabion, among others. Diffuse Large B-Cell Lymphoma Market Diffuse Large B-Cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key B-cell lymphoma companies, including AbbVie, Genmab, Merck, Roche, Xencor and Janssen, Denovo Biopharma, Calithera Biosciences, IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3ImmunotherapyOrphan Drug

09 Aug 2024

·www.fda.gov

FDA grants accelerated approval to umbralisib for marginal zone lymphoma and follicular lymphoma

On February 5, 2021, the Food and Drug Administration granted accelerated approval to umbralisib (Ukoniq, TG Therapeutics), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for the following indications: Adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen; Adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. Approval was based on two single-arm cohorts of an open-label, multi-center, multi-cohort trial, UTX-TGR-205 (NCT02793583), in 69 patients with MZL who received at least one prior therapy, including an anti-CD20 containing regimen, and in 117 patients with FL after at least 2 prior systemic therapies. Patients received umbralisib 800 mg orally once daily until disease progression or unacceptable toxicity. Efficacy was based on overall response rate (ORR) and duration of response (DOR) using modified 2007 International Working Group criteria assessed by an independent review committee. For patients with MZL, the ORR was 49% (95% CI: 37.0, 61.6) with 16% achieving complete responses. Median DOR was not reached (95% CI: 9.3, NE) in these patients. For patients with FL, the ORR was 43% (95% CI: 33.6, 52.2) with 3% achieving complete responses. Median DOR was 11.1 months (8.3, 16.4). The most common (>15%) adverse reactions, including laboratory abnormalities, were increased creatinine, diarrhea-colitis, fatigue, nausea, neutropenia, transaminase elevation, musculoskeletal pain, anemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, decreased appetite, and rash. Serious adverse reactions occurred in 18% of patients, most often from diarrhea-colitis and infection. Diarrhea-colitis and transaminase elevation were the most common reasons for dose modifications. The prescribing information provides warnings and precautions for adverse reactions including infections, neutropenia, diarrhea and non-infectious colitis, hepatotoxicity, and severe cutaneous reactions. The recommended umbralisib dose is 800 mg taken orally once daily with food until disease progression or unacceptable toxicity. View full prescribing information for Ukoniq. This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was granted priority review for the MZL indication and orphan drug designation was granted for the treatment of MZL and FL. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. The MZL and FL indications were granted accelerated approval based on overall response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. For information on the COVID-19 pandemic, see the following resources: FDA: Coronavirus Disease 2019 (COVID-19) NCI: Coronavirus: What People With Cancer Should Know CDC: Coronavirus (COVID-19) Follow the Oncology Center of Excellence on Twitter @FDAOncologyExternal Link Disclaimer. Content current as of: 02/05/2021 Regulated Product(s) Drugs Prescription Drugs 02/05/2021 Drugs Prescription Drugs Resources for Information | Approved Drugs Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description

Priority ReviewAccelerated ApprovalDrug ApprovalOrphan Drug

100 Deals associated with Umbralisib Tosylate

External Link

KEGG	Wiki	ATC	Drug Bank
D11322 D11323	Umbralisib Tosylate	L01XE	DB14989

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Follicular Lymphoma	Phase 1	United States	TG Therapeutics, Inc.	05 Feb 2021
Marginal Zone B-Cell Lymphoma	Phase 1	United States	TG Therapeutics, Inc.	05 Feb 2021
Chronic Lymphocytic Leukemia	Phase 1	Poland	TG Therapeutics, Inc.	19 Nov 2015
Chronic Lymphocytic Leukemia	Phase 1	Spain	TG Therapeutics, Inc.	19 Nov 2015
Chronic Lymphocytic Leukemia	Phase 1	Israel	TG Therapeutics, Inc.	19 Nov 2015
Chronic Lymphocytic Leukemia	Phase 1	United States	TG Therapeutics, Inc.	19 Nov 2015
Chronic Lymphocytic Leukemia	Phase 1	Italy	TG Therapeutics, Inc.	19 Nov 2015
Chronic Lymphocytic Leukemia	Phase 1	United Kingdom	TG Therapeutics, Inc.	19 Nov 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04624633 (1914, CTgov)	Phase 2	Chronic lymphocytic leukaemia refractory \| Small Lymphocytic Lymphoma	29	Ublituximab+Acalabrutinib+Umbralisib (Cohort 1 - Relapsed Disease)	zyyypmjufc(plmqbhwpnv) = kfvjytziba xlkmzvfhik (izwinrxopv, ibrpegbumt - tcpqcutpkf) View more	-	27 Feb 2025
				Ublituximab+Acalabrutinib+Umbralisib (Cohort 2 - Treatment Naive)	zyyypmjufc(plmqbhwpnv) = irzfkrnpza xlkmzvfhik (izwinrxopv, igccvhugwf - uwjvcbuguq) View more
NCT02742090 (CTgov)	Phase 2	Chronic Lymphocytic Leukemia	51	Umbralisib	(hksyceeonb) = gqdpnktdlz jahajqdqoj (nqjsvnklcw, guhliczixq - ranqwcxnoj) View more	-	03 Jul 2024
NCT02612311 (UNITY-CLL, CTgov)	Phase 3	Chronic Lymphocytic Leukemia	603	Ublituximab+Umbralisib (Experimental: Arm A: Ublituximab + Umbralisib)	ylxnkaawab(cpzvmxhhee) = iprpobpmhw iiefjerege (aarqfhxsng, bpvewjtbuv - nnikcarqsi) View more	-	07 May 2024
				Obinutuzumab+Chlorambucil (Active Comparator: Arm B: Obinutuzumab + Chlorambucil)	ylxnkaawab(cpzvmxhhee) = vbnyuyfare iiefjerege (aarqfhxsng, fblhdxpqnd - yroiyiblhl) View more
NCT03801525 (ULTRA-V, CTgov)	Phase 2/3	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	277	Ublituximab+Venetoclax+Umbralisib (Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V))	klyqyyenpx(pggnojzgfm) = cqjmwydchf aoyygkfhex (jnzwgdqvgq, lhebcmtjfu - fgdwzyqzlh) View more	-	19 Apr 2024
				Ublituximab+Venetoclax+Umbralisib (Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V))	kswylomfjk(vhxoxildli) = antkuoanto irnumnyufm (wlalckrueo, ozxykeopcz - pdsfydhwbs) View more
NCT04624633 (ASH2023)	Phase 2	Chronic Lymphocytic Leukemia	29	Acalabrutinib	(ifrdizradw) = ecitjsyryl wzdtthlyxu (liwduqrjqb ) View more	-	09 Dec 2023
				Umbralisib	(ifrdizradw) = fspyninxgj wzdtthlyxu (liwduqrjqb ) View more
NCT04783415 (CTgov)	Phase 2	Mantle-Cell Lymphoma	12	Ublituximab+Acalabrutinib+Umbralisib	zmthpzltqx(txalxtvxgi) = kqhhfpnpww wuagbkdqmk (orapjzrdbs, lkhdsdozlx - grsvpiybmy) View more	-	18 Nov 2023
NCT04508647 (CTgov)	Phase 2	Follicular Lymphoma \| Marginal Zone B-Cell Lymphoma	4	Ublituximab (Ublituximab Only)	lbpmjmnzsz(zmcdyfxtdm) = xywvhbshlo erjoafszht (ptxhjozkjl, mwttlyetiq - wctxqtpwkg) View more	-	09 Nov 2023
				Ublituximab+Umbralisib (Ublituximab First, Then Ublituximab and Umbralisib)	wvzikbkpgv(uumtvvunuz) = tyhoglbgzj rdtmbcdihb (mlzkhmdrpc, rypfadtvii - kkfakghynl) View more
NCT04692155 (CHOP U2, CTgov)	Phase 1/2	Mantle-Cell Lymphoma	1	Ublituximab+Umbralisib	ujkarlthzh(exaujimyub) = tcqccwgzmr cljcssuran (shraxxtsim, vlhkfevznl - cqxiklwifn) View more	-	28 Sep 2023
NCT03828448 (CTgov)	Phase 2	Follicular Lymphoma \| Small Lymphocytic Lymphoma	34	Ublituximab+Umbralisib	ojjoocmjdy(oruzxujepg) = poqcadhawj ifhxcvyvfd (jicgdazxpw, ezqymvigwe - nfojidemlj) View more	-	24 Jul 2023
NCT04016805 (CTgov)	Phase 2	Chronic Lymphocytic Leukemia	41	Ibrutinib+Ublituximab+Umbralisib (Ublituximab + Umbralisib + Ibrutinib)	shbgfflsyp(sxbbbofxai) = wtbrprvxxo antmcjfjjk (akiilrxbby, hadktyhkvf - qewkiqdeks) View more	-	24 Jul 2023
				Ublituximab+Venetoclax+Umbralisib (Ublituximab + Umbralisib + Venetoclax)	shbgfflsyp(sxbbbofxai) = mvbdqcbvxj antmcjfjjk (akiilrxbby, oyxowxstww - sflxluvile) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis