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

121

Literatures (Medical) associated with Umbralisib Tosylate

01 Jun 2025·EUROPEAN JOURNAL OF PHARMACOLOGY

Targeting PI3K in cancer treatment: A comprehensive review with insights from clinical outcomes

Review

Author: Hossain, Md Arafat ; Hossain, Md Takdir

The phosphoinositide 3-kinase (PI3K) pathway plays a crucial role in cancer, including cell growth, survival, metabolism, and metastasis. Its major role in tumor growth makes it a key target for cancer therapeutics, offering significant potential to slow tumor progression and enhance patient outcomes. Gain-of-function mutations, gene amplifications, and the loss of regulatory proteins like PTEN are frequently observed in malignancies, contributing to tumor development and resistance to conventional treatments such as chemotherapy and hormone therapy. As a result, PI3K inhibitors have received a lot of interest in cancer research. Several kinds of small-molecule PI3K inhibitors have been developed, including pan-PI3K inhibitors, isoform-specific inhibitors, and dual PI3K/mTOR inhibitors, each targeting a distinct component of the pathway. Some PI3K inhibitors such as idelalisib, copanlisib, duvelisib, alpelisib, and umbralisib have received FDA-approval, and are effective in the treatment of breast cancer and hematologic malignancies. Despite promising results in preclinical and clinical trials, the overall clinical success of PI3K inhibitors has been mixed. While some patients may get substantial advantages, a considerable number of them acquire resistance as a result of feedback activation of alternative pathways, adaptive tumor responses, and treatment-emergent mutations. The resistance mechanisms provide barriers to the sustained efficacy of PI3K-targeted treatments. This study reviews recent advancements in PI3K inhibitors, covering their clinical status, mechanism of action, resistance mechanisms, and strategies to overcome resistance.

15 May 2025·CLINICAL CANCER RESEARCH

Protein Profiles Predict Treatment Responses to the PI3K Inhibitor Umbralisib in Patients with Chronic Lymphocytic Leukemia

Article

Author: Aittokallio, Tero ; Mato, Anthony R. ; Xu, Haifeng ; Brown, Jennifer R. ; Yin, Yanping ; Skånland, Sigrid S. ; He, Liye

Abstract:

Purpose::

The management of chronic lymphocytic leukemia (CLL) has significantly improved with targeted therapies. However, many patients experience a suboptimal response. To optimally select the best therapy, predictive biomarkers are necessary. In this study, we used the phosphoinositide 3-kinase (PI3K) inhibitor umbralisib as a model to (i) understand the impact of targeted treatment on cell signaling and immunophenotypes in responders and nonresponders, (ii) identify molecular features that predict individual treatment responses, and (iii) suggest alternative treatment options for the nonresponders.

Experimental Design::

We performed functional phenotyping of CLL cells from patients enrolled in two clinical trials with umbralisib, administered either as a monotherapy (NCT02742090, n = 55) or in combination with the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (NCT04624633, n = 12).

Results::

We found that umbralisib monotherapy led to significant changes in (phospho)protein levels, including AKT (pS473), in responders but not in nonresponders. Furthermore, the proportion of cytotoxic natural killer (NK) cells increased at the end of the study but only in responders, suggesting a role in the antitumor response. To identify molecular predictors of response, we used the baseline levels of 30 (phospho)proteins in the monotherapy cohort as input features for a machine learning model, which achieved significant prediction accuracy in cross-validation and maintained its predictive power in the combination cohort. Drug sensitivity profiling of the CLL cells at baseline suggested that PI3K + Bcl-2 inhibitors are effective in umbralisib nonresponders.

Conclusions::

Functional phenotyping reveals differential cellular responses to umbralisib treatment in responders and nonresponders; predicts treatment response of individual patients with CLL; and suggests alternative treatment options for the nonresponders.

01 May 2025·BRITISH JOURNAL OF HAEMATOLOGY

A chemotherapy‐free regimen of acalabrutinib, umbralisib and ublituximab achieved high response rates and undetectable minimal residual disease in patients with untreated mantle cell lymphoma

Article

Author: Muir, Alexandra ; Lopedote, Paolo ; Miskin, Hari ; Chen, Lu ; Shouse, Geoffrey ; Roleder, Carly ; Sportelli, Peter ; Danilov, Alexey V. ; Puverel, Sandrine ; Phillips, Tycel J.

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

Withdrawn | Cancer Accelerated Approvals

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. Visit the ongoing or verified AA indication pages for more information. Withdrawn indications are not listed until FDA publishes a Federal Register notice to that effect or updates product labeling. Ukoniq (umbralisib) Previous 1 2 3 Next

Accelerated Approval

100 Deals associated with Umbralisib Tosylate

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KEGG	Wiki	ATC	Drug Bank
D11322 D11323	Umbralisib Tosylate	L01XE	DB14989

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Follicular Lymphoma	United States	TG Therapeutics, Inc.	05 Feb 2021
Marginal Zone B-Cell Lymphoma	United States	TG Therapeutics, Inc.	05 Feb 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diffuse Large B-Cell Lymphoma	Phase 3	United States	TG Therapeutics, Inc.	25 May 2016
Diffuse Large B-Cell Lymphoma	Phase 3	Australia	TG Therapeutics, Inc.	25 May 2016
Diffuse Large B-Cell Lymphoma	Phase 3	Israel	TG Therapeutics, Inc.	25 May 2016
Diffuse Large B-Cell Lymphoma	Phase 3	Italy	TG Therapeutics, Inc.	25 May 2016
Diffuse Large B-Cell Lymphoma	Phase 3	Poland	TG Therapeutics, Inc.	25 May 2016
Diffuse Large B-Cell Lymphoma	Phase 3	Slovakia	TG Therapeutics, Inc.	25 May 2016
Diffuse Large B-Cell Lymphoma	Phase 3	Spain	TG Therapeutics, Inc.	25 May 2016
Diffuse Large B-Cell Lymphoma	Phase 3	United Kingdom	TG Therapeutics, Inc.	25 May 2016
Mantle-Cell Lymphoma	Phase 3	United States	TG Therapeutics, Inc.	25 May 2016
Mantle-Cell Lymphoma	Phase 3	Australia	TG Therapeutics, Inc.	25 May 2016

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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)	jvkoqsbbvc = byjpkxosss lkeymuijok (ewhigdgeny, kmyawrvlkz - sbbenqyrzt) View more	-	27 Feb 2025
				Ublituximab+Acalabrutinib+Umbralisib (Cohort 2 - Treatment Naive)	jvkoqsbbvc = owpboxveds lkeymuijok (ewhigdgeny, ungbnscmhd - ddspapzcvy) View more
NCT02742090 (CTgov)	Phase 2	Chronic Lymphocytic Leukemia	51	Umbralisib	nftjziuufn(vlferaeaba) = hfmdncijff wxomqonhvv (gbmtgeakgz, qedhnxzszo - icqbqmqdal) View more	-	03 Jul 2024
NCT02612311 (UNITY-CLL, CTgov)	Phase 3	Chronic Lymphocytic Leukemia	603	Ublituximab+Umbralisib (Experimental: Arm A: Ublituximab + Umbralisib)	wmrbfgviyf(svkufyccfo) = absxyboncl pkcrsbpgxw (dqizuoruuh, srzipzkvwm - ljfxjhfdkh) View more	-	07 May 2024
				Chlorambucil+Obinutuzumab (Active Comparator: Arm B: Obinutuzumab + Chlorambucil)	wmrbfgviyf(svkufyccfo) = zvohrbmohu pkcrsbpgxw (dqizuoruuh, biqicqlbez - whokurvcln) 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))	rnfthsldzl = risxiwdprr rddgdbdyit (clmbpatqgl, ufhlbyfbyr - fnxsikyrrt) View more	-	19 Apr 2024
				Ublituximab+Venetoclax+Umbralisib (Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V))	pzfivhynow(eibymjfrpg) = gbbzcunzmg zqmfiqyzwc (yqudccehiq, kboewvragb - rlqvffapgv) View more
NCT04624633 (ASH2023)	Phase 2	Chronic Lymphocytic Leukemia	29	Acalabrutinib	rkifkbsyak(juhoipntgq) = exfckctldt eerxmasqpg (adyizmnmhw ) View more	-	09 Dec 2023
				Umbralisib	rkifkbsyak(juhoipntgq) = rmswrahgnp eerxmasqpg (adyizmnmhw ) View more
NCT04783415 (CTgov)	Phase 2	Mantle-Cell Lymphoma	12	Ublituximab+Acalabrutinib+Umbralisib	rmfzcrlzkj = ejuqhrbpfx aqclhaopoo (bbgmshiuac, eldhbcgxay - cvwstmwbou) View more	-	18 Nov 2023
NCT04508647 (CTgov)	Phase 2	Follicular Lymphoma \| Marginal Zone B-Cell Lymphoma	4	Ublituximab (Ublituximab Only)	vjthpkugos = ezmruxnhxk kwtbmtekci (zaieiedhlt, ujbtzkuvjm - dwkrbmhxpk) View more	-	09 Nov 2023
				Ublituximab+Umbralisib (Ublituximab First, Then Ublituximab and Umbralisib)	bkvdkdhmrq = kazcvdwdqt ybmiwchcfm (wkmrmntrbe, jsixedtjwv - bcbjfpgeba) View more
NCT04692155 (CHOP U2, CTgov)	Phase 1/2	Mantle-Cell Lymphoma	1	Ublituximab+Umbralisib	pjlqkokoxl = kpleksgpny erlacgfscl (qatrapnfyd, tcrunwdtnc - nucmerfwow) View more	-	28 Sep 2023
NCT03828448 (CTgov)	Phase 2	Follicular Lymphoma \| Small Lymphocytic Lymphoma	34	Ublituximab+Umbralisib	sbfmcvuiby(lgmbbeaana) = okwrjhptno tymghgqwte (qtssezgizr, xrmobgtbyo - rpchjfivcz) View more	-	24 Jul 2023
NCT04016805 (CTgov)	Phase 2	Chronic Lymphocytic Leukemia	41	Ibrutinib+Ublituximab+Umbralisib (Ublituximab + Umbralisib + Ibrutinib)	jeqwshncfb(otrccahyhe) = wacrppnvjk akqornablc (xhzcwfjljr, ddipwwqoek - mcnculptzj) View more	-	24 Jul 2023
				Ublituximab+Venetoclax+Umbralisib (Ublituximab + Umbralisib + Venetoclax)	jeqwshncfb(otrccahyhe) = kgotewmczs akqornablc (xhzcwfjljr, hfocpjqapi - gkdgpobhoy) View more

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