- |||||||||| Columvi (glofitamab-gxbm) / Roche, Rituxan (rituximab) / Roche
Trial completion date, Trial primary completion date, Combination therapy: GO43693: A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma (clinicaltrials.gov) - Feb 23, 2024 P1, N=40, Recruiting, Patients with underlying HEM may be at increased risk for severe disease compared with others receiving the same BCDT. Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Jun 2024 --> Dec 2024
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Roche
Journal, Real-world evidence, Real-world: Treatment Outcomes with Standard of Care in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Real-World Data Analysis. (Pubmed Central) - Feb 22, 2024 Outcomes in patients with R/R DLBCL treated with chemotherapy, single-agent rituximab/obinutuzumab, single-agent lenalidomide, or combinations of these agents remain poor, especially for those with challenging-to-treat R/R DLBCL. These findings underscore the unmet need for new, safe, and effective therapies, especially for challenging-to-treat R/R DLBCL populations.
- |||||||||| Anyara (naptumomab estafenatox) / NeoTX
Phase classification, Trial completion date, Trial primary completion date, Combination therapy, Metastases: Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - Feb 22, 2024 P1, N=60, Active, not recruiting, These findings underscore the unmet need for new, safe, and effective therapies, especially for challenging-to-treat R/R DLBCL populations. Phase classification: P1b --> P1 | Trial completion date: Aug 2025 --> Oct 2026 | Trial primary completion date: May 2025 --> Oct 2026
- |||||||||| Anyara (naptumomab estafenatox) / NeoTX
Trial completion, Phase classification, Trial completion date, Combination therapy, Checkpoint inhibition, Metastases: NT-NAP-102-1: Naptumomab Estafenatox (NAP) in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic NSCLC (clinicaltrials.gov) - Feb 22, 2024 P2, N=38, Completed, Phase classification: P1b --> P1 | Trial completion date: Aug 2025 --> Oct 2026 | Trial primary completion date: May 2025 --> Oct 2026 Active, not recruiting --> Completed | Phase classification: P2a --> P2 | Trial completion date: Jul 2024 --> Jan 2024
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen
Prolonged COVID-19 Pneumonia in a Patient on Obinutuzumab for Treatment of Follicular Lymphoma (San Diego Convention Center, Area K (Hall H, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_6012; Introduction: Obinutuzumab is an anti-CD20 monoclonal antibody that is often used as immunotherapy in combination with bendamustine to treat hematological malignancies such as non-Hodgkin lymphoma...One study found that obinutuzumab, in particular, was significantly more likely to cause severe-to-critical COVID-19 infection than rituximab (35% vs 7...Remdesivir and corticosteroids were immediately initiated...Despite guideline-based treatment of COVID-19 infection while hospitalized, his condition continued to decline. Vigilant monitoring for infections, timely intervention, and a multidisciplinary approach are essential in providing comprehensive care and optimizing patient outcomes in such clinical scenarios.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen
An Original Occurrence of Organizing Pneumonia From Obinutuzumab (San Diego Convention Center, Area D (Hall A-B2, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_3783; Case: A 67-year-old male with history of follicular lymphoma previously treated with chemotherapy, including rituximab, presented with shortness of breath and cough for two weeks...The patient started prednisone dosed at 1 mg/kg...Secondary organizing pneumonia should be considered on the differential diagnosis in patients taking Obinutuzumab who present with suspected pneumonia and do not improve with empiric antibiotic therapy. Early bronchoscopy with biopsy may be helpful in this particular patient population.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen
Pulmonary Nodules in Immunosuppressed Patient (San Diego Convention Center, Area I (Hall H, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_1952; Pulmonary nodules in immunocompromised patients have a wide differential. It is important to rule out CNS involvement in cases of disseminated cryptococcal infections as the treatment is different.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, magrolimab (GS-4721) / Ono Pharma
Trial primary completion date: Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies (clinicaltrials.gov) - Feb 15, 2024 P1, N=1, Active, not recruiting, The 90-min obinutuzumab SDI might be safe and feasible in patients with B-cell NHL in China. Trial primary completion date: Feb 2026 --> Mar 2024
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Zelboraf (vemurafenib) / Roche
Trial completion date, Trial primary completion date: A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia (clinicaltrials.gov) - Feb 15, 2024 P2, N=30, Active, not recruiting, Trial primary completion date: Feb 2026 --> Mar 2024 Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, magrolimab (GS-4721) / Ono Pharma
Enrollment closed, Enrollment change, Trial completion date: Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies (clinicaltrials.gov) - Feb 12, 2024 P1, N=1, Active, not recruiting, Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025 Recruiting --> Active, not recruiting | N=76 --> 1 | Trial completion date: Jun 2028 --> Feb 2027
- |||||||||| Epkinly (epcoritamab-bysp) / Genmab, AbbVie
Enrollment open, Adverse events, Combination therapy: EPCORE (clinicaltrials.gov) - Feb 7, 2024 P3, N=900, Recruiting, No dose-limiting toxicity was observed. Not yet recruiting --> Recruiting
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Trial primary completion date: Obinutuzumab, Ibrutinib, and Venetoclax for the Treatment of Previously Untreated Stage II-IV Follicular Lymphoma (clinicaltrials.gov) - Jan 22, 2024 P2, N=40, Recruiting, Trial completion date: May 2026 --> Jul 2023 | Active, not recruiting --> Terminated; slow accrual Trial completion date: May 2024 --> Apr 2025 | Trial primary completion date: Oct 2023 --> Oct 2024
- |||||||||| Epkinly (epcoritamab-bysp) / Genmab, AbbVie
Trial initiation date, Adverse events, Combination therapy: EPCORE (clinicaltrials.gov) - Jan 19, 2024 P3, N=900, Not yet recruiting, Trial completion date: May 2024 --> Apr 2025 | Trial primary completion date: Oct 2023 --> Oct 2024 Initiation date: Mar 2026 --> Jan 2024
- |||||||||| Benlysta (belimumab) / GSK, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Saphnelo (anifrolumab) / AstraZeneca
Journal: Immunology: what's new in 2023 (Pubmed Central) - Jan 17, 2024 These advances diversify SLE management, though their long-term efficacy remains to be established. It is crucial to emphasize basic measures in patients with SLE, including smoking cessation, sun protection, and early use of hydroxychloroquine.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Trial primary completion date, Combination therapy: Bcl-2 Inhibitor GDC-0199 in Combination With Obinutuzumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or Previously Untreated Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Jan 11, 2024 P1/2, N=87, Active, not recruiting, It is crucial to emphasize basic measures in patients with SLE, including smoking cessation, sun protection, and early use of hydroxychloroquine. Trial completion date: Aug 2023 --> Dec 2024 | Trial primary completion date: Aug 2023 --> Dec 2024
- |||||||||| Columvi (glofitamab-gxbm) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Trial initiation date: Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov) - Jan 11, 2024 P2, N=40, Not yet recruiting, Not yet recruiting --> Recruiting Initiation date: Dec 2023 --> Mar 2024
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal: The Acquisition of Complement-Dependent Cytotoxicity by the Type II Anti-CD20 Therapeutic Antibody Obinutuzumab. (Pubmed Central) - Jan 11, 2024 Long-term (24 h) overall cytotoxicity of obinutuzumab was improved in target cells of moderate sensitivity to complement but diminished in cells of low sensitivity. Our results demonstrate that the ability of complement activation of a given antibody is not ultimately determined at the stage of initial interactions with its target antigen but is modulable at later stages of the cascade and that the benefit of the acquisition of this new effector mechanism by obinutuzumab depends on the target cell characteristics.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Phase classification: Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma (clinicaltrials.gov) - Jan 9, 2024 P1/2, N=145, Recruiting, Our results demonstrate that the ability of complement activation of a given antibody is not ultimately determined at the stage of initial interactions with its target antigen but is modulable at later stages of the cascade and that the benefit of the acquisition of this new effector mechanism by obinutuzumab depends on the target cell characteristics. Phase classification: P1b/2 --> P1/2
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
The Case of My Career! Interesting Cases Shared by Giants in the Field of Renal Pathology - Haas (BCC Room 314) - Jan 9, 2024 - Abstract #USCAP2024USCAP_603; Following the biopsy, the patient was treated with corticosteroids, 2 doses of obinutuzumab (anti-CD20), and subsequently plasma exchange x 5...A repeat biopsy was thus performed to assess disease activity and chronicity. Figure 3: Click to view full size Figure 4: Click to view full size Figure 5: Click to view full size Figure 6: Click to view full size Figure 7: Click to view full size Figure 8: Click to view full size Figure 9: Click to view full size Figure 10: Click to view full size
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment closed, Trial completion date, Trial primary completion date: A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy (clinicaltrials.gov) - Jan 8, 2024 P3, N=140, Active, not recruiting, Figure 3: Click to view full size Figure 4: Click to view full size Figure 5: Click to view full size Figure 6: Click to view full size Figure 7: Click to view full size Figure 8: Click to view full size Figure 9: Click to view full size Figure 10: Click to view full size Recruiting --> Active, not recruiting | Trial completion date: May 2027 --> Dec 2027 | Trial primary completion date: Jan 2025 --> Dec 2025
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Journal: Acquired von Willebrand's Syndrome in a Patient with Concomitant Chronic Lymphocytic Lymphoma and Smoldering Multiple Myeloma. (Pubmed Central) - Jan 7, 2024 Decision was made to treat the underlying CLL initially with rituximab and later on at recurrence with obinutuzumab/venetoclax with complete resolution of patient's bleeding and normalization of her factor VIII activity, von Willebrand factor antigen levels, and vWF:ristocetin cofactor levels. We believe this is first case in the literature of a patient with AvWS with concurrent CLL and SMM.
- |||||||||| Epkinly (epcoritamab-bysp) / Genmab, AbbVie
New P3 trial, Adverse events, Combination therapy: EPCORE (clinicaltrials.gov) - Jan 5, 2024 P3, N=900, Not yet recruiting,
- |||||||||| Review, Journal: Maintenance therapy for chronic lymphocytic leukaemia. (Pubmed Central) - Jan 4, 2024
The effects of alemtuzumab maintenance are uncertain, coupled with a warning for drug-related infectious toxicity. We found no studies evaluating other novel maintenance interventions, such as B-cell receptor inhibitors, B-cell leukaemia-2/lymphoma-2 inhibitors, or obinutuzumab.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date, Trial primary completion date, Minimal residual disease: VIS: Front-line VenObi Combination Followed by Ven or VenZan Combination in Patients With Residual Disease: a MRD Tailored Treatment for Young Patients With High-risk CLL (clinicaltrials.gov) - Dec 31, 2023 P2, N=78, Recruiting,
- |||||||||| Columvi (glofitamab-gxbm) / Roche, Polivy (polatuzumab vedotin-piiq) / Roche, Tecentriq (atezolizumab) / Roche
Trial initiation date, Combination therapy, Monotherapy: A Ph 2 Study of Glofitamab Alone or in Combination With Polatuzumab Vedotin or Atezolizumab in Richter's Transformation (clinicaltrials.gov) - Dec 28, 2023 P2, N=66, Recruiting, We found no studies evaluating other novel maintenance interventions, such as B-cell receptor inhibitors, B-cell leukaemia-2/lymphoma-2 inhibitors, or obinutuzumab. Initiation date: Oct 2023 --> Apr 2024
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Journal: Cross-Reactivity of Antibodies to Rituximab with Other Therapeutic Anti-CD20 Antibodies. (Pubmed Central) - Dec 27, 2023 Our results suggest that obinutuzumab or ofatumumab are safe anti-CD20 alternatives in case of the presence of anti-rituximab Abs. It is advisable to proceed cautiously if switching from rituximab to ocrelizumab (or vice versa) is considered in case these alternatives may not be available.
- |||||||||| Polivy (polatuzumab vedotin-piiq) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Roche
Phase classification, Combination therapy: GO29834: A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (clinicaltrials.gov) - Dec 25, 2023 P1/2, N=114, Completed, It is advisable to proceed cautiously if switching from rituximab to ocrelizumab (or vice versa) is considered in case these alternatives may not be available. Phase classification: P1 --> P1/2
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