- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen
Clinical, Journal: A 63-Year-Old Woman with a History of Non-Hodgkin Lymphoma with Persistent SARS-CoV-2 Infection Who Was Seronegative and Treated with Convalescent Plasma. (Pubmed Central) - Oct 15, 2020
CASE REPORT A 63-year-old woman with a past medical history of non-Hodgkin lymphoma in remission while on maintenance therapy with the anti-CD20 monoclonal antibody, obinutuzumab, tested positive for SARS-CoV-2 via nasopharyngeal reverse transcription polymerase chain reaction (RT-PCR) testing over 12 weeks and persistently tested seronegative for immunoglobulin G (IgG) antibodies using SARS-CoV-2 IgG chemiluminescent microparticle immunoassay technology...Since humoral immunity has an integral role in SARS-CoV-2 infection, various phase 3 vaccine trials are underway. In the context of this pandemic, the present case demonstrates the challenges in our understanding of testing and treating immunocompromised patients.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Trial completion, Combination therapy: A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) - Oct 13, 2020
P1, N=84, Completed,
Ethics Approval The anti-tumor efficacy studies in mice were approved by the internal ethics board of the respective contract research organization (CRO). Active, not recruiting --> Completed
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen
Journal: Venetoclax-obinutuzumab: harnessing complexity. (Pubmed Central) - Oct 11, 2020
Such objective classification method has potential value to help minimize reading variability between pathologists. No abstract available
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Roche
Trial completion date, Trial primary completion date, PD(L)-1 Biomarker: Pembrolizumab With Rituximab or Obinutuzumab in Treating Patients With Relapsed or Refractory Follicular Lymphoma or Diffuse Large B Cell Lymphoma (clinicaltrials.gov) - Oct 9, 2020
P2, N=37, Recruiting,
No abstract available Trial completion date: Feb 2021 --> Feb 2023 | Trial primary completion date: Feb 2021 --> Feb 2023
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: A Tridimensional Model for NK Cell-Mediated ADCC of Follicular Lymphoma. (Pubmed Central) - Oct 7, 2020
The effect of GA101 seems to be more pronounced as observed in vivo in a xenograft FL model. This study strongly supports the role of NK cells in FL and highlights the application of the 3D co-culture model for in vitro validation.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment open: CLL2-BZAG: Sequential Regimen of Bendamustine Followed by Obinutuzumab (GA101), Zanubrutinib (BGB-3111) and Venetoclax (ABT-199) in Patients With Relapsed/Refractory CLL (clinicaltrials.gov) - Oct 4, 2020
P2, N=40, Recruiting,
This study strongly supports the role of NK cells in FL and highlights the application of the 3D co-culture model for in vitro validation. Not yet recruiting --> Recruiting
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche, bendamustine / Generic mfg., Bioprofarma
[VIRTUAL] Pharmacoeconomic Analisys of Obinutuzumab in Combination with Bendamustine Followed By Obinutuzumab Maintenance Versus Bendamustine ALONE in Treatment of Patients with Rituximab‑Refractory Follicular Lymphoma in Ecuador. () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1645;
The additional investment that the state should make in this group of patients ranges from $ 15,000 to $ 20,000 per year per patient, depending on the treatment phase and the accumulation of cases, especially in year 3 and 5. CONCLUSIONS : Currently in Ecuador the recent approval of Bendamustine for the treatment of Lymphoma is a great step in the therapy of patients, however, the additional investment that the payer must make to increase the survival of these patients to almost double that obtained with the standard of treatment would justify the inclusion of Obinutuzumab gradually and if necessary through agreements between payers and manufacturing.
- |||||||||| Darzalex IV (daratumumab) / J&J
[VIRTUAL] Health-Economic Evaluation in Hemato-Oncology - Insights on French Practice () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1359;
The HAS/CEESP concluded that only three dossiers demonstrated the efficiency; the ICER was partially validated in one dossier and 14 opinions were not validated due to major caveats. The analysis of the objections allowed to highlight the parameters on which pharmaceutical manufacturers need to be more robust and rigorous, for cost effectiveness analyses in hemato-oncology.
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Interaction kinetics with transcriptomic and secretory responses of CD19-CAR natural killer-cell therapy in CD20 resistant non-hodgkin lymphoma. (Pubmed Central) - Oct 1, 2020
We investigated the cytolytic and mechanistic activity of anti-CD19 chimeric antigen receptor natural killer (CD19.CAR.NK92) therapy in lymphoma cell lines (diffuse large B-cell, follicular, and Burkitt lymphoma), including rituximab- and obinutuzumab-resistant cells, patient-derived cells, and a human xenograft model...Furthermore, a 92-plex cytokine panel analysis showed increased secretion of granzymes, increased secretion of FASL, CCL3, and IL10 in anti-CD20 resistant SUDHL4 cells with induction of genes relevant to mTOR and G2/M checkpoint activation, which were noted in all anti-CD20 resistant cells co-cultured with CD19.CAR.NK92 cells. Collectively, CD19.CAR.NK92 was associated with potent anti-lymphoma activity across a host of sensitive and resistant lymphoma cells that involved distinct immuno-biologic mechanisms of cell death.
- |||||||||| Trial completion date, Trial primary completion date, FDG PET, Metastases: Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer (clinicaltrials.gov) - Oct 1, 2020
P1, N=26, Suspended,
Collectively, CD19.CAR.NK92 was associated with potent anti-lymphoma activity across a host of sensitive and resistant lymphoma cells that involved distinct immuno-biologic mechanisms of cell death. Trial completion date: Dec 2020 --> May 2022 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial primary completion date: Obinutuzumab, Venetoclax, and Lenalidomide in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - Sep 28, 2020
P1, N=60, Suspended,
Our data suggests that patients with 2NDNR to rituximab, which constituted 11% of all patients initiated on this drug, should be switched within the same biologic class to another anti-CD20 agent. Trial primary completion date: Jan 2020 --> Dec 2020
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen
Clinical, P3 data, Clinical Trial,Phase III, Journal: Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (CLL14): follow-up results from a multicentre, open-label, randomised, phase 3 trial. (Pubmed Central) - Sep 25, 2020
P3
Active, not recruiting --> Completed 2 years after treatment cessation, venetoclax plus obinutuzumab continues to significantly improve progression-survival compared with chlorambucil plus obinutuzumab, thereby providing a limited duration treatment option for patients with previously untreated chronic lymphocytic leukaemia.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, P3 data, PK/PD data, Journal: Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN Phase III study. (Pubmed Central) - Sep 23, 2020
The updated population PK model reported here accurately describes the PK of obinutuzumab patients with NHL and CLL. The selected obinutuzumab dosing regimen offers clinical benefit in a majority of rituximab-refractory FL patients treated with bendamustine, irrespective of variability in exposure, whilst minimising adverse events.
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] Current therapy for indolent lymphomas (ATİLLA YALÇIN HALL) - Sep 23, 2020 - Abstract #EHOC2020EHOC_29;
There seems to be a favorable group that can be treated with Rituximab monotherapy and remain without need for new treatment for a long period.3 After the GALLIUM trial,4 where Obinutuzumab was associated with 34% reduction in progression versus Rituximab, this novel anti-CD20 antibody became an option...To reduce toxicity while maintaining efficacy, Lenalidomide plus Rituximab regimen was tested in untreated FL patients (“R2”).6 This “chemo-free” protocol had an equal PFS rate at 3 years compared with Rituximab plus Chemotherapy, with less hematological toxicity and neutropenic fever...Acalabrutinib and Venetoclax are other new options, with the last as one of the few active treatments in patient's refractory to ibrutinib.16Marginal Zone B-cell lymphomas (MZL): The marginal zone B-cell lymphomas (MZLs) comprise extra nodal MZL (EMZL) of mucosa-associated lymphoid tissue (MALT), splenic MZL (SMZL) with or without villous lymphocytes and nodal MZL (NMZL) with or without monocytoid B cells...Rituximab therapy alone can be indicated and has an important response rate with minimal toxicity, particular useful in patients with autoimmune disorders.20 For asymptomatic patient diagnosed with NMZL is also recommended only observation. If systemic treatment is indicated, chemo-immunotherapy can be performed.21
- |||||||||| Leustatin (cladribine) / J&J, Opdivo (nivolumab) / Ono Pharma, BMS, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] New drugs for low grade lymphoproliferative diseases (ATİLLA YALÇIN HALL) - Sep 23, 2020 - Abstract #EHOC2020EHOC_28;
Tazemetostat a novel EZH2 inhibitor recently received accelerated approval by FDA for patients with RR-FL and EZH2 gene mutations, following the results of a phase-II study...Immune check point inhibitors (Nivolumab, Pemprolizumab, Atezolizumab) are promising as third line treatment and beyond. Other agents under investigation include the inhibitor of nuclear export selinexor, the SYK inhibitor entospletinib, the dual SYK/JAK inhibitor certulatinib and the CDK inhibitors flavopiridol and dinaciclib.
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] How can we estimate early relapsed follicular lymphoma and how can we treat? (ATİLLA YALÇIN HALL) - Sep 23, 2020 - Abstract #EHOC2020EHOC_20;
For fit patients age <65 years without an appropriate clinical trial option consolidative autologous stem cell transplant should be considered to induce prolonged remissions and improve prognosis. Nevertheless, there is an unmet need for better identification and treatment of POD 24 patients.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
New P2 trial: Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL (clinicaltrials.gov) - Sep 22, 2020
P2, N=40, Not yet recruiting,
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Trial initiation date, Trial primary completion date: Obinutuzumab, Ibrutinib, and Venetoclax for the Treatment of Previously Untreated Stage II-IV Follicular Lymphoma (clinicaltrials.gov) - Sep 21, 2020
P2, N=40, Not yet recruiting,
Trial completion date: Sep 2020 --> Aug 2025 Trial completion date: Dec 2023 --> May 2024 | Initiation date: Jul 2020 --> Oct 2020 | Trial primary completion date: Jun 2023 --> Oct 2023
- |||||||||| sonrotoclax (BGB-11417) / BeiGene
Trial completion date, Trial primary completion date: BGB-11417-101: Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies (clinicaltrials.gov) - Sep 19, 2020
P1a/1b, N=116, Recruiting,
Trial completion date: Dec 2023 --> May 2024 | Initiation date: Jul 2020 --> Oct 2020 | Trial primary completion date: Jun 2023 --> Oct 2023 Trial completion date: Jun 2026 --> Jun 2023 | Trial primary completion date: Mar 2023 --> Jun 2023
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Enrollment open, Combination therapy: Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Sep 19, 2020
P2, N=60, Recruiting,
Trial completion date: Jun 2026 --> Jun 2023 | Trial primary completion date: Mar 2023 --> Jun 2023 Not yet recruiting --> Recruiting
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
WATCH: Alexey V. Danilov, MD, PhD, of @cityofhope, and @DrCarlaCasulo, of @WilmotCancer, describe the design and outcomes of the GALLIUM study of obinutuzumab versus rituximab in previously untreated follicular lymphoma. #lymsm https://t.co/y3UN49eaTP (Twitter) - Sep 18, 2020
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Enrollment open, Trial initiation date: Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - Sep 16, 2020
P2, N=168, Recruiting,
These findings indicate that the number of NK cells in peripheral blood may affect the outcome of B-cell non-Hodgkin lymphoma patients receiving anti-CD20-based immunochemotherapy. Not yet recruiting --> Recruiting | Initiation date: Mar 2020 --> Jul 2020
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Binding mechanisms of therapeutic antibodies to human CD20. (Pubmed Central) - Sep 16, 2020
Among type I mAbs, ofatumumab complexes display optimal geometry for complement recruitment. The uncovered mechanisms should aid rational design of next-generation immunotherapies targeting CD20.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen
[VIRTUAL] A Case of Strongyloides Hyperinfection Syndrome in an Immunocompromised Patient () - Sep 15, 2020 - Abstract #ACG2020ACG_1235;
Case Description/ A 67-year-old male with leukemia on ibrutinib and obinutuzumab presented with persistent non-productive cough and dyspnea unresponsive to methylprednisolone...He was treated for pneumonia, yet had worsening hypoxia with suspicion for Pneumocystis pneumonia, and was started on trimethoprim-sulfamethoxazole and prednisone with paradoxical worsening respiratory failure requiring intubation...He was treated with subcutaneous ivermectin and albendazole with persistent shock...This case highlights classic features of SHS including eosinophilia, cough with progressive respiratory failure, thumb-print purpuric rash, and gastrointestinal symptoms. Due to significant mortality, it is critical to maintain a high index of suspicion and carefully consider steroid use in immunocompromised patients with this constellation of symptoms.
- |||||||||| Remicade (infliximab) / Mitsubishi Tanabe, J&J
[VIRTUAL] To Treat or Not to Treat? () - Sep 15, 2020 - Abstract #ACG2020ACG_1118;
Case Description/ This is the case of a 69-year-old male with history of non-treated CLL and Crohn’s disease on infliximab who presented for a surveillance colonoscopy to the endoscopic unit...Therefore, the oncology service recommended to start CLL treatment with obinutuzumab and venetoclax...CLL increases the risk for progressive immunodeficiency, affecting all elements of the immune system which, in the setting of a concomitant condition like Crohn’s disease and the need for the use of additional immunosuppressors, increases even more the risk of severe infections from bacteria and viruses. For this reason, our case emphasizes the fact of how a multidisciplinary approach between sub-specialties can provide a better route map for managing difficult cases like this one, in which providing treatment for either condition can complicate the patient’s clinical picture.
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