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- Zynlonta (loncastuximab tesirine-lpyl) / Overland ADCT BioPharma
Limited Duration Loncastuximab Tesirine Induces a High Rate of Complete Responses in Patients with Relapsed/Refractory Marginal Zone Lymphoma - Report of First Planned Interim Futility Analysis of a Multicenter Phase II Study (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_5074;
P2
Premedication with dexamethasone 4 mg twice daily for 3 days and prophylaxis with spironolactone 100 mg (to prevent fluid overload) was required...At the time of study design, the best reported CR rate in r/r MZL was 16% achieved with umbralisib, that we used as P0 assumption under the null hypothesis...Across all lines of treatment, the most common treatments were R-chemotherapy (n=18), targeted/immuno-modulatory agents (n=7) and single-agent rituximab (n=7); 1 patient had CAR-T...The patient clinically fully recovered with normalization in LFTs abnormalities. Conclusion : Lonca is demonstrating clinically meaningful activity with robust CR rate in r/r MZL patients in our ongoing phase 2 study.
- Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab-xiiy) / TG Therap, Calquence (acalabrutinib) / AstraZeneca
Acalabrutinib, Umbralisib and Ublituximab Regimen (AU2) Demonstrates High Response Rate and Undetectable Molecular Minimal Residual Disease (MRD) in Patients (pts) with De Novo Mantle Cell Lymphoma (MCL) (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_5019;
P2
AU2 is a highly effective regimen in pts with previously untreated MCL, including those with high-risk genetics (100% CR rate), and achieves a high molecular uMRD rate. Pts who develop progressive disease can be effectively salvaged with subsequent therapies.
- Ukoniq (umbralisib) / TG Therap, Calquence (acalabrutinib) / AstraZeneca
Clonal Evolution during Dual B Cell Receptor Pathway Inhibitor Therapy with Acalabrutinib and Umbralisib in CLL Patients (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_3917;
Overall, these findings highlight that even in the setting of clinical response with dual BCR pathway inhibitor therapy, clonal evolution is ongoing in genes potentially associated with resistance. Further clinical follow-up of this study will be required to associate evolving mutations with duration of response or progression-free survival.
- || Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab-xiiy) / TG Therap, Calquence (acalabrutinib) / AstraZeneca
Trial primary completion date: Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL (clinicaltrials.gov) - Nov 4, 2024
P2, N=60, Active, not recruiting, Sponsor: Jennifer R. Brown, MD, PhD
Further clinical follow-up of this study will be required to associate evolving mutations with duration of response or progression-free survival. Trial primary completion date: Dec 2023 --> Dec 2026
- || Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab-xiiy) / TG Therap, Calquence (acalabrutinib) / AstraZeneca
Trial primary completion date: Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL (clinicaltrials.gov) - Oct 15, 2024
P2, N=60, Active, not recruiting, Sponsor: Jennifer R. Brown, MD, PhD
Trial primary completion date: Dec 2023 --> Dec 2026 Trial primary completion date: Jan 2025 --> Dec 2023
- || Retrospective data, Review, Journal: Safety Profile of First-Line Targeted Therapies in Elderly and/or Comorbid Chronic Lymphocytic Leukaemia Patients (Unfit Subpopulation). A Systematic Review and Network Meta-Analysis. (Pubmed Central) - Aug 17, 2024
In conclusion, targeted therapies are associated with variable and clinically relevant AEs. The therapies appear to be safer when used as monotherapy rather than in combination with immunological agents in na
- ||| P4 data, Journal, Adverse events: Post-marketing safety concern of PI3K inhibitors in the cancer therapies: an 8-year disproportionality analysis from the FDA adverse event reporting system. (Pubmed Central) - Jul 31, 2024
and PI3K?), and idelalisib (inhibitingPI3K?) were developed to target the PI3K pathway...The safety profiles of the five PI3K inhibitorsvary concerning adverse events. These findings could guide drug selection andinform future prospective research.
- | Ukoniq (umbralisib) / TG Therap, Gazyva (obinutuzumab) / Roche, Biogen
Enrollment closed: SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov) - Jul 17, 2024
P2, N=95, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
These findings could guide drug selection andinform future prospective research. Recruiting --> Active, not recruiting
- New Agents in Marginal Zone Lymphoma (Level 3, 370 BE) - Jul 5, 2024 - Abstract #SOHO2024SOHO_12;
P2
The median overall survival (OS) was not reached.5 The ACE-LY-003 study evaluated acalabrutinib in 43 R/R MZL patients...The CITADEL-204 study evaluated PI3Kd inhibitor parsaclisib daily dosing in 72 R/R MZL patients.8 The ORR was 58% with a CR rate of 4.2%, a median DOR of 12.2 months, and a median PFS of 16.5 months...Umbralisib, a dual PI3Kd/casein kinase 1e inhibitor, was evaluated in 69 R/R MZL patients in the UNITY-NHL study.9 The ORR was 49% with a CR of 16%, and the median DOR and median PFS were not reached...The double-blinded, randomized, placebo-controlled phase III CHRONOS-3 trial evaluated copanlisib with rituximab vs. rituximab in CD20-positive indolent NHL (iNHL)...The Zuma-5 clinical trial evaluated axicabtagene ciloleucel in R/R iNHL and included 24 patients (16%) with R/R MZL.11 In patients with MZL, the ORR was 83% with a CR rate of 65%...Bispecific antibodies targeting CD20 and CD3 that redirect T cells to engage and eliminate malignant B cells and antibody-drug conjugates, such as loncastuximab tesirine, demonstrated excellent responses in FL and aggressive NHL; however, scarce data exist for MZL...Therefore, targeting of only one aberrant signaling pathway may not be sufficient to completely eliminate the tumor. Therefore, usage of combination therapies, including bispecific antibodies and antibody-drug conjugates, may represent the next step toward the cure of MZL patients.
- | Journal: PI3K inhibitors in hematology: When one door closes (Pubmed Central) - Jul 5, 2024
Given the uncertain future of this drug class, additional manufacturers terminated ongoing phase III trials with novel PI3K inhibitors. Here, we review the development and current status of PI3K inhibitors in hematology, limitations to their use, and our perspective on whether there is a future for PI3K inhibitors in hematology.
- ||||| Ukoniq (umbralisib) / TG Therap
Trial termination: Evaluate the Efficacy and Safety of TGR-1202 in Participants With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy (clinicaltrials.gov) - Jul 3, 2024
P2, N=51, Terminated, Sponsor: TG Therapeutics, Inc.
Here, we review the development and current status of PI3K inhibitors in hematology, limitations to their use, and our perspective on whether there is a future for PI3K inhibitors in hematology. Completed --> Terminated; (Strategic/Business Decision)
- |||| edralbrutinib (TG-1701) / TG Therap
Trial termination: TG-1701-101: Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies (clinicaltrials.gov) - Jun 27, 2024
P1, N=172, Terminated, Sponsor: TG Therapeutics, Inc.
Completed --> Terminated; (Strategic/Business Decision) Active, not recruiting --> Terminated; Strategic/Business Decision
- | Jakafi (ruxolitinib) / Incyte, Ukoniq (umbralisib) / TG Therap
Trial completion, Trial completion date: TGR-1202 + Ruxolitinib PMF PPV-MF PET-MF MDS/MPN Polycythemia Vera Resistant to Hydroxyurea (clinicaltrials.gov) - Jun 26, 2024
P1, N=60, Completed, Sponsor: Vanderbilt-Ingram Cancer Center
Active, not recruiting --> Terminated; Strategic/Business Decision Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> May 2024
- || Ukoniq (umbralisib) / TG Therap, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion, Trial completion date, Combination therapy: A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL (clinicaltrials.gov) - May 8, 2024
P1, N=45, Completed, Sponsor: Dana-Farber Cancer Institute
Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> May 2024 Active, not recruiting --> Completed | Trial completion date: Mar 2024 --> Aug 2023
- | Ukoniq (umbralisib) / TG Therap, Rituxan (rituximab) / Roche
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Umbralisib and Rituximab as Initial Therapy for Patients With Follicular Lymphoma and Marginal Zone Lymphoma (clinicaltrials.gov) - May 8, 2024
P2, N=18, Terminated, Sponsor: Massachusetts General Hospital
Active, not recruiting --> Completed | Trial completion date: Mar 2024 --> Aug 2023 N=41 --> 18 | Trial completion date: Nov 2024 --> May 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2023 --> May 2024; Umbralisib development terminated; closed to accrual 8/29/2022
- ||||||||| Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab-xiiy) / TG Therap
Trial termination, Combination therapy: UNITY-CLL: Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia (clinicaltrials.gov) - May 7, 2024
P3, N=603, Terminated, Sponsor: TG Therapeutics, Inc.
N=41 --> 18 | Trial completion date: Nov 2024 --> May 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2023 --> May 2024; Umbralisib development terminated; closed to accrual 8/29/2022 Completed --> Terminated; Strategic/Business decision
- | Ukoniq (umbralisib) / TG Therap, Gazyva (obinutuzumab) / Roche, Biogen
Trial completion date, Trial primary completion date: SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov) - Apr 17, 2024
P2, N=95, Recruiting, Sponsor: National Cancer Institute (NCI)
Completed --> Terminated; Strategic/Business decision Trial completion date: Jun 2024 --> Dec 2025 | Trial primary completion date: Jun 2024 --> Dec 2025
- Ukoniq (umbralisib) / TG Therap, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma () - Apr 5, 2024 - Abstract #SWOGSpring2024SWOG_Spring_77;
One patient on the Lenalidomide + Obinutuzumab arm experienced Grade 4 haemophilus influenza (listed as "Infections/infestations-Other" and "Investigations Other, specify"). Twenty-seven other patients experienced Grade 3 adverse events as maximum degree.
- | FDA event, Journal: An Expedition on Synthetic Methodology of FDA-approved Anticancer Drugs (2018-2021). (Pubmed Central) - Jan 30, 2024
The review comprises the key structural features, approval times, target selectivity, mechanisms of action, therapeutic indication, formulations, and possible synthetic approaches of these approved drugs. These crucial details will benefit the scientific community for futuristic new developments in this arena.
- | Ukoniq (umbralisib) / TG Therap, Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date: Combination of Pembrolizumab With TGR-1202 in Patients With Relapsed/Refractory CLL and B-cell NHL (clinicaltrials.gov) - Jan 29, 2024
P1, N=20, Active, not recruiting, Sponsor: University of Chicago
These crucial details will benefit the scientific community for futuristic new developments in this arena. Trial completion date: Dec 2024 --> Dec 2027 | Trial primary completion date: Dec 2023 --> Dec 2027
- | Venclexta (venetoclax) / Roche, AbbVie, Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab-xiiy) / TG Therap, Neuraxpharm
Journal: Response-Adapted, Time-Limited Venetoclax, Umbralisib and Ublituximab for Relapsed/Refractory Chronic Lymphocytic Leukemia. (Pubmed Central) - Jan 15, 2024
P1/2
Time-limited venetoclax and U2 is safe and highly effective combination therapy for relapsed/refractory CLL patient including those who have been previously treated with covalent BTK inhibitors. This trial was registered on ClinicalTrials.gov under identifier: NCT03379051.
- | Ukoniq (umbralisib) / TG Therap, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Combination therapy: A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL (clinicaltrials.gov) - Jan 9, 2024
P1, N=45, Active, not recruiting, Sponsor: Dana-Farber Cancer Institute
This trial was registered on ClinicalTrials.gov under identifier: NCT03379051. Trial completion date: Dec 2023 --> Mar 2024
- || edralbrutinib (TG-1701) / TG Therap
Trial completion date, Trial primary completion date: TG-1701-101: Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies (clinicaltrials.gov) - Dec 20, 2023
P1, N=172, Active, not recruiting, Sponsor: TG Therapeutics, Inc.
- | Zynlonta (loncastuximab tesirine-lpyl) / Overland ADCT BioPharma
Phase classification, Combination therapy: LOTIS 7: A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7) (clinicaltrials.gov) - Dec 20, 2023
P1, N=200, Recruiting, Sponsor: ADC Therapeutics S.A.
Trial completion date: Dec 2023 --> Mar 2024 Phase classification: P1b --> P1
- | Lunsumio (mosunetuzumab) / Roche, Biogen
Journal: Indirect Treatment Comparisons of Mosunetuzumab With Third- and Later-Line Treatments for Relapsed/Refractory Follicular Lymphoma. (Pubmed Central) - Nov 19, 2023
P1/2
Although preliminary results somewhat favored CART therapies, limitations and uncertainties remain because of intrinsic differences in study design. Mosunetuzumab could thus be a promising treatment option for patients with RR FL after ?2 prior therapies.
- | Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab-xiiy) / TG Therap, Calquence (acalabrutinib) / AstraZeneca
Trial completion date, Combination therapy: Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma (clinicaltrials.gov) - Nov 18, 2023
P2, N=12, Active, not recruiting, Sponsor: City of Hope Medical Center
Mosunetuzumab could thus be a promising treatment option for patients with RR FL after ?2 prior therapies. Trial completion date: Sep 2023 --> Sep 2025
- Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab-xiiy) / TG Therap, Neuraxpharm, Calquence (acalabrutinib) / AstraZeneca
A Phase 2 Study of Acalabrutinib, Umbralisib, and Ublituximab (AU2) in Treatment-Na (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2342;
P2
Immune-related adverse events were frequently observed and required dose reduction of umbralisib in 38% of the patients but most were then able to stay on therapy. Longer follow-up is required to determine durability of remission off therapy.
- | Jakafi (ruxolitinib) / Incyte, Ukoniq (umbralisib) / TG Therap
Trial primary completion date: TGR-1202 + Ruxolitinib PMF PPV-MF PET-MF MDS/MPN Polycythemia Vera Resistant to Hydroxyurea (clinicaltrials.gov) - Aug 24, 2023
P1, N=60, Active, not recruiting, Sponsor: Vanderbilt-Ingram Cancer Center
Longer follow-up is required to determine durability of remission off therapy. Trial primary completion date: Dec 2023 --> Mar 2023
- Predictive modeling of treatment outcomes in chronic lymphocytic leukemia based on functional profiles at baseline () - Aug 14, 2023 - Abstract #IWCLL2023IWCLL_225;
P2
There were no significant differences in (phospho)protein profiles between intermediate and undetectable MRD groups. In the umbralisib cohort, the (phospho)protein levels were significantly higher in CLL cells from responders than from non-responders for 8 proteins (p<0.05), including MEK1 (pS298), mTOR (pS2448), and p90 RSK (pS380).
- Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab-xiiy) / TG Therap, Neuraxpharm
Enrollment change: UTX-TGR-208: Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax (clinicaltrials.gov) - Jul 27, 2023
P2, N=41, Terminated, Sponsor: TG Therapeutics, Inc.
In the umbralisib cohort, the (phospho)protein levels were significantly higher in CLL cells from responders than from non-responders for 8 proteins (p<0.05), including MEK1 (pS298), mTOR (pS2448), and p90 RSK (pS380). N=84 --> 41
- ||||||| Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab-xiiy) / TG Therap
Trial completion, Trial completion date, Trial primary completion date, Combination therapy: UNITY-CLL: Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Jul 20, 2023
P3, N=603, Completed, Sponsor: TG Therapeutics, Inc.
N=84 --> 41 Active, not recruiting --> Completed | Trial completion date: Jan 2024 --> Feb 2023 | Trial primary completion date: Nov 2023 --> Feb 2023
- | Ukoniq (umbralisib) / TG Therap, Rituxan (rituximab) / Roche
Enrollment closed, Trial primary completion date: Umbralisib and Rituximab as Initial Therapy for Patients With Follicular Lymphoma and Marginal Zone Lymphoma (clinicaltrials.gov) - Jul 7, 2023
P2, N=41, Active, not recruiting, Sponsor: Massachusetts General Hospital
Active, not recruiting --> Completed | Trial completion date: Jan 2024 --> Feb 2023 | Trial primary completion date: Nov 2023 --> Feb 2023 Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2022 --> Nov 2023
- || edralbrutinib (TG-1701) / TG Therap
Trial completion date, Trial primary completion date: TG-1701-101: Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies (clinicaltrials.gov) - Jun 23, 2023
P1, N=172, Active, not recruiting, Sponsor: TG Therapeutics, Inc.
Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2022 --> Nov 2023 Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Jun 2024
- || Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab) / TG Therap
P2 data, Journal: Phase 2 trial of umbralisib, ublituximab, and venetoclax in patients with relapsed/refractory mantle cell lymphoma. (Pubmed Central) - Jun 21, 2023
Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Jun 2024 No abstract available
- | Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab-xiiy) / TG Therap
Enrollment change, Trial termination: Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy (clinicaltrials.gov) - Jun 15, 2023
P2, N=1, Terminated, Sponsor: Weill Medical College of Cornell University
No abstract available N=24 --> 1 | Recruiting --> Terminated; Terminated due to low accrual
- | Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab-xiiy) / TG Therap, Tazverik (tazemetostat) / Eisai, Ipsen
Enrollment change, Trial withdrawal, Combination therapy: Tazemetostat in Combination With Umbralisib and Ublituximab for the Treatment Relapsed or Refractory Follicular Lymphoma (clinicaltrials.gov) - May 31, 2023
P1/2, N=0, Withdrawn, Sponsor: City of Hope Medical Center
N=24 --> 1 | Recruiting --> Terminated; Terminated due to low accrual N=48 --> 0 | Not yet recruiting --> Withdrawn
- | Ukoniq (umbralisib) / TG Therap, Zydelig (idelalisib) / Gilead, Copiktra (duvelisib) / Secura Bio, Yakult Honsha
Preclinical, Journal: Dual inhibition of phosphoinositide 3-kinases delta and gamma reduces chronic B cell activation and autoantibody production in a mouse model of lupus. (Pubmed Central) - May 30, 2023
and PI3K? can target autoreactive B cells and may have therapeutic benefits in autoantibody-mediated disease.
- || Review, Journal: Management of Gastro-Intestinal Toxicity of the Pi3 Kinase Inhibitor: Optimizing Future Dosing Strategies. (Pubmed Central) - May 16, 2023
We further review the available worldwide pharmacovigilance data in relation to these drugs. Finally, we describe our own real-world experience with idelalisib-induced colitis management in our center and in a national setting.
- | Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab) / TG Therap, NI-1701 / TG Therap
Journal, Checkpoint inhibition, IO biomarker, Checkpoint block: G protein-coupled receptor 183 mediates the sensitization of Burkitt lymphoma tumors to CD47 immune checkpoint blockade by anti-CD20/PI3K?i dual therapy. (Pubmed Central) - May 12, 2023
Genetic depletion and pharmacological inhibition of GPR183 impaired ADCP initiation, cytoskeleton remodeling and cell migration in 2D and 3D spheroid B-NHL co-cultures, and disrupted macrophage-mediated control of tumor growth in B-NHL CAM xenografts. Altogether, our results support a crucial role for GPR183 in the recognition and elimination of malignant B cells upon concomitant targeting of CD20, CD47 and PI3K?, and warrant further clinical evaluation of this triplet regimen in B-NHL.
- Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab) / TG Therap
Venetoclax based combination therapy does not overcome poor outcomes in BTKi-refractory mantle cell lymphoma: phase 2 trial of umbralisib, ublituximab, and venetoclax () - May 4, 2023 - Abstract #ICML2023ICML_637;
- Association of pharmacist interventions with adherence upon targeted anticancer oral therapy initiation. (On Demand | Hall A; Poster Bd # 127) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3980;
To our knowledge, this is the first study to quantify the impact of an OP on non-adherence in a real-world setting. Our findings suggest a critical need to integrate OPs TAO therapy initiation workflows.
- | Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab-xiiy) / TG Therap
Trial completion, Enrollment change, Trial completion date: Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma (clinicaltrials.gov) - Apr 18, 2023
P2, N=4, Completed, Sponsor: University of Colorado, Denver
Our findings suggest a critical need to integrate OPs TAO therapy initiation workflows. Suspended --> Completed | N=24 --> 4 | Trial completion date: Dec 2023 --> Jun 2022
- | Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab-xiiy) / TG Therap, Neuraxpharm
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy: Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V) (clinicaltrials.gov) - Apr 10, 2023
P2/3, N=271, Terminated, Sponsor: TG Therapeutics, Inc.
Suspended --> Completed | N=24 --> 4 | Trial completion date: Dec 2023 --> Jun 2022 N=700 --> 271 | Trial completion date: Mar 2025 --> Dec 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2025 --> Dec 2022; Strategic/Business decision
- | Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab-xiiy) / TG Therap
Trial primary completion date: Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma (clinicaltrials.gov) - Apr 3, 2023
P2, N=24, Suspended, Sponsor: University of Colorado, Denver
N=700 --> 271 | Trial completion date: Mar 2025 --> Dec 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2025 --> Dec 2022; Strategic/Business decision Trial primary completion date: Jul 2023 --> Jul 2022
- | Ukoniq (umbralisib) / TG Therap
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: TGR-1202 (Umbralisib) in Treatment Na (clinicaltrials.gov) - Mar 24, 2023
P2, N=12, Terminated, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Trial primary completion date: Jul 2023 --> Jul 2022 N=35 --> 12 | Trial completion date: Nov 2023 --> Oct 2022 | Suspended --> Terminated | Trial primary completion date: Nov 2023 --> Oct 2022; Drug no longer available
- | Ukoniq (umbralisib) / TG Therap
Journal: Design of Novel Phosphatidylinositol 3-Kinase Inhibitors for Non-Hodgkin's Lymphoma: Molecular Docking, Molecular Dynamics, and Density Functional Theory Studies on Gold Nanoparticles. (Pubmed Central) - Mar 16, 2023
The best interaction with gold was observed at the oxygen atom number 5 with -29.42 Kcal/mol. Further in vitro and in vivo investigations are recommended to be carried out to verify the anticancer activity of this analogue.
- ERBB4-mediated signaling is a mediator of resistance to BTK and PI3K inhibitors in B cell lymphoid neoplasms (Section 14; Poster Board #20) - Mar 14, 2023 - Abstract #AACR2023AACR_2497;
Our results indicate that epigenetic plasticity led to the activation of HBEGF-ERBB signaling sustaining resistance to BTK/PI3K inhibitors, which can be overcome using epigenetic agents and ERBB inhibitors. These therapeutics approaches could be tested in novel clinical trials.
- | Ukoniq (umbralisib) / TG Therap, Gazyva (obinutuzumab) / Roche, Biogen
Enrollment open: SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov) - Mar 14, 2023
P2, N=95, Recruiting, Sponsor: National Cancer Institute (NCI)
These therapeutics approaches could be tested in novel clinical trials. Suspended --> Recruiting
- | Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab-xiiy) / TG Therap, Calquence (acalabrutinib) / AstraZeneca
Enrollment closed, Enrollment change, Combination therapy: Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma (clinicaltrials.gov) - Mar 1, 2023
P2, N=12, Active, not recruiting, Sponsor: City of Hope Medical Center
Suspended --> Recruiting Suspended --> Active, not recruiting | N=27 --> 12
- | Ukoniq (umbralisib) / TG Therap, Keytruda (pembrolizumab) / Merck (MSD)
Trial primary completion date: Combination of Pembrolizumab With TGR-1202 in Patients With Relapsed/Refractory CLL and B-cell NHL (clinicaltrials.gov) - Feb 16, 2023
P1, N=20, Active, not recruiting, Sponsor: University of Chicago
Suspended --> Active, not recruiting | N=27 --> 12 Trial primary completion date: Dec 2022 --> Dec 2023