- |||||||||| Does the Life Expectancy of Elderly CLL Patients Receiving Upfront Targeted Agents Approach the Life Expectancy of the General Population? (Hynes Convention Center Exhibit Hall D, Level 2 900 Boylston St., Boston, MA) - Aug 14, 2023 - Abstract #IWCLL2023IWCLL_115;
Patients enrolled in the CT/CIT arms received chlorambucil (C) as a single agent (14.3%), Bendamustine-Rituximab (BR, 19.6%), C-obinutuzumab (CO, 66%)...Nonetheless, the results of this analysis evaluating the upfront administration of TAs on OS suggest these agents have substantially mitigated but not fully eliminated the shorter OS of CLL patients relative to the AGMGP. Continued development of novel treatment approaches to improve outcome for patients with CLL is needed.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Columvi (glofitamab-gxbm) / Roche, Gazyva (obinutuzumab) / Roche, Biogen
Enrollment open: NCI-2023-03181: Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma (clinicaltrials.gov) - Aug 14, 2023
P1/2, N=50, Recruiting,
Trial completion date: Feb 2023 --> Aug 2023 | Trial primary completion date: Feb 2023 --> Aug 2023 Not yet recruiting --> Recruiting
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Review, Journal: First-Line Treatment of Older Patients with CLL: A New Approach in the Chemo-Free Era. (Pubmed Central) - Aug 12, 2023
Though targeted agents were shown to be cost-effective treatments in high-income countries, the out-of-pocket expenses may limit accessibility to these drugs, and the overall expenditure for new drugs in CLL is projected to increase substantially, posing an issue for sustainability. This being said, the choice of a finite-duration treatment based on venetoclax-containing regimens or treatment until progression with BTKi is today possible in high-income countries, and the therapy choice drivers are represented by coexisting medical conditions rather than age, patient expectations, logistics, and sustainability.
- |||||||||| Columvi (glofitamab-gxbm) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche, Biogen
Trial completion date, Trial primary completion date, Combination therapy: CO43805: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - Aug 8, 2023
P1, N=121, Recruiting,
Modulation of hypoxia and the purinergic pathway might contribute to therapeutic restoration of T-cell function. Trial completion date: Apr 2027 --> Jul 2028 | Trial primary completion date: Apr 2025 --> Jul 2026
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date, Trial primary completion date, Metastases: Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN) (clinicaltrials.gov) - Aug 7, 2023
P=N/A, N=299, Active, not recruiting,
Trial completion date: Apr 2027 --> Jul 2028 | Trial primary completion date: Apr 2025 --> Jul 2026 Trial completion date: Dec 2024 --> Apr 2024 | Trial primary completion date: Dec 2024 --> Apr 2024
- |||||||||| Review, Journal: Future landscape for the management of membranous nephropathy. (Pubmed Central) - Aug 2, 2023
In addition, several technologies and innovations developed primarily for cancer (e.g. chimeric antigen receptor T-cell therapy, sweeping antibodies) seem particularly promising. In summary, the future therapeutic landscape in MN seems encouraging and will definitely move the management of this disease towards a more precision-based approach.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie
Trial completion, Combination therapy: A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy (clinicaltrials.gov) - Aug 2, 2023
P3b, N=120, Completed,
In summary, the future therapeutic landscape in MN seems encouraging and will definitely move the management of this disease towards a more precision-based approach. Active, not recruiting --> Completed
- |||||||||| Columvi (glofitamab-gxbm) / Roche, Gazyva (obinutuzumab) / Roche, Biogen
Enrollment open: Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma (clinicaltrials.gov) - Jul 27, 2023
P2, N=50, Recruiting,
Trial completion date: Aug 2025 --> Aug 2027 | Trial primary completion date: Aug 2025 --> Aug 2027 Not yet recruiting --> Recruiting
- |||||||||| War and the fragility of anticancer drug supply networks in Ukraine () - Jul 27, 2023 - Abstract #ESMO2023ESMO_3203;
10 (32%) were limited per 9-12: ibrutinib, mercaptopurine, eltrombopag, erythropoietin, thrombopoietin, ruxolitinib, venetoclax, brentuximab, gemtuzumab, obinutuzumab...Conclusions Shortages of essential anticancer drugs are a continued challenge in Ukraine during the war. Results are limited by small sample size and limited sampling from regions affected by active hostilities.
- |||||||||| Trial completion date, Trial primary completion date, Combination therapy: Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma (clinicaltrials.gov) - Jul 21, 2023
P1, N=55, Recruiting,
This bioassay is very sensitive and adaptable to assess anti-viral antibodies but unsuitable as a surrogate assay to monitor cell death after ADCC. Trial completion date: Jul 2028 --> Jul 2029 | Trial primary completion date: Jul 2023 --> Jul 2024
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Roche, Epkinly (epcoritamab-bysp) / Genmab, AbbVie
Enrollment open: REFRACT: Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy (clinicaltrials.gov) - Jul 20, 2023
P2, N=284, Recruiting,
Trial completion date: Jul 2028 --> Jul 2029 | Trial primary completion date: Jul 2023 --> Jul 2024 Not yet recruiting --> Recruiting
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Roche
Enrollment closed, Trial completion date: CRISTALLO: A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation (clinicaltrials.gov) - Jul 20, 2023
P3, N=166, Active, not recruiting,
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Jul 2026
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen
Enrollment closed, Enrollment change, Trial primary completion date: Bendamustine + Obinutuzumab Induction With Obinutuzumab Maintenance in Untreated Mantle Cell Lymphoma (clinicaltrials.gov) - Jul 20, 2023
P2, N=21, Active, not recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Jul 2026 Recruiting --> Active, not recruiting | N=32 --> 21 | Trial primary completion date: May 2024 --> Jul 2023
- |||||||||| Ukoniq (umbralisib) / TG Therap, Briumvi (ublituximab-xiiy) / TG Therap, Neuraxpharm
Trial completion, Trial completion date, Trial primary completion date, Combination therapy: UNITY-CLL: Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Patients With Untreated and Previously Treated Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Jul 20, 2023
P3, N=603, Completed,
Recruiting --> Active, not recruiting | N=32 --> 21 | Trial primary completion date: May 2024 --> Jul 2023 Active, not recruiting --> Completed | Trial completion date: Jan 2024 --> Feb 2023 | Trial primary completion date: Nov 2023 --> Feb 2023
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Retrospective data, Journal, Real-world evidence, Real-world: Rituximab versus obinutuzumab-based first-line chemoimmunotherapy for follicular lymphoma-a real-world multicenter retrospective cohort study. (Pubmed Central) - Jul 17, 2023
No statistically significant difference was evident in adverse events of grades 3-5 (76.9% vs. 82%, p?=?0.427). To conclude, in this largest real-life study of first-line treated FL patients comparing R- to O-based therapy, we did not observe any difference in toxicity during the induction and 6
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche, Nulojix (belatacept) / BMS
Review, Journal: Strategies for ABO Incompatible Liver Transplantation. (Pubmed Central) - Jul 13, 2023
Introduction of newer therapies like Belatacept and Obinutuzumab hold promise to further improve outcomes and reduce the risk of antibody mediated rejection related complications. ABOi LT in emergency situations like acute liver failure and deceased donor LT is challenging due to limited time period for desensitisation protocol before transplant, and available evidence are still limited but encouraging.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Clinical, Combination therapy, Monotherapy: According to Jeff Sharman, MD, "#acalabrutinib, as monotherapy or in combination with #obinutuzumab, resulted in a statistically significant and clinically important improvement" of treatment outcomes for #CLL. Learn more: https://t.co/HblQBmtzgO @jeff_sharman (Twitter) - Jul 13, 2023
- |||||||||| Monjuvi (tafasitamab-cxix) / Incyte, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
New P1 trial: Tafasitamab, Acalabrutinib, and Obinutuzumab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Jul 13, 2023
P1, N=25, Not yet recruiting,
- |||||||||| iberdomide (CC-220) / BMS
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: A Dose Finding and Safety Study of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Lymphomas (clinicaltrials.gov) - Jul 12, 2023
P1/2, N=62, Active, not recruiting,
ABOi LT in emergency situations like acute liver failure and deceased donor LT is challenging due to limited time period for desensitisation protocol before transplant, and available evidence are still limited but encouraging. N=232 --> 62 | Trial completion date: Apr 2025 --> Jan 2025 | Trial primary completion date: Aug 2023 --> Mar 2023
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Roche
Trial completion date: Pembrolizumab With Rituximab or Obinutuzumab in Treating Patients With Relapsed or Refractory Follicular Lymphoma or Diffuse Large B Cell Lymphoma (clinicaltrials.gov) - Jul 10, 2023
P2, N=18, Active, not recruiting,
Recruiting --> Active, not recruiting Trial completion date: Jul 2024 --> Jan 2026
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Trial completion date, Trial primary completion date: Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL (clinicaltrials.gov) - Jul 7, 2023
P2, N=40, Recruiting,
Active, not recruiting --> Recruiting Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2022 --> Mar 2025
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Onureg (azacitidine oral) / BMS, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion, Trial completion date, Trial primary completion date: A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma (clinicaltrials.gov) - Jul 7, 2023
P1/2, N=2, Completed,
Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2022 --> Mar 2025 Active, not recruiting --> Completed | Trial completion date: Aug 2024 --> Mar 2023 | Trial primary completion date: Feb 2024 --> Mar 2023
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Zydelig (idelalisib) / Gilead
Trial termination: GAUDEALIS: Idelalisib+Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma (clinicaltrials.gov) - Jul 6, 2023
P2, N=5, Terminated,
Active, not recruiting --> Completed | Trial completion date: Aug 2024 --> Mar 2023 | Trial primary completion date: Feb 2024 --> Mar 2023 Active, not recruiting --> Terminated; Study was halted prematurely due to safety, since tocity stopping rules have been met
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Trial completion date: CLL2-BAAG: Sequential Regimen of Bendamustin-Debulking Followed by Obinutuzumab, Acalabrutinib and Venetoclax in Patients With Relapsed/Refractory CLL (clinicaltrials.gov) - Jul 6, 2023
P2, N=46, Active, not recruiting,
Active, not recruiting --> Terminated; Study was halted prematurely due to safety, since tocity stopping rules have been met Trial completion date: May 2023 --> Oct 2023
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date, Trial primary completion date: Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) (clinicaltrials.gov) - Jul 5, 2023
P2, N=230, Recruiting,
These data demonstrate the long-term benefit of obinutuzumab-based immunochemotherapy and confirm its role as a standard-of-care for the first-line treatment of advanced-stage FL, taking into account patient characteristics and safety considerations. Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
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