- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Randomized Phase III Study of Early Intervention with Venetoclax and Obinutuzumab Versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL): EVOLVE CLL/SLL Study. (Regency C (Ballroom Level, West Tower)) - Oct 28, 2023 - Abstract #SWOGFall2023SWOG_Fall_144; Formal interim analyses for futility are planned after approximately 40%, 60%, and 80% of the expected events have occurred across both arms. Summary Statement For the current status of this study, please refer to the Leukemia chapter.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab Versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study. (Regency A (Ballroom Level, West Tower)) - Oct 28, 2023 - Abstract #SWOGFall2023SWOG_Fall_51; Formal interim analyses for futility are planned after approximately 40%, 60%, and 80% of the expected events have occurred across both arms. Summary Statement For the current status of this study, please refer to the Leukemia chapter.
- |||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Otsuka, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Review, Journal: Lupus Nephritis in Children: Novel Perspectives. (Pubmed Central) - Oct 28, 2023 Moreover, current literature often lacks pediatric-specific data, leading clinicians to rely exclusively on adult therapeutic approaches. This review aims to describe pediatric lupus nephritis and provide an overview of the novel perspectives on the pathogenetic mechanisms, histopathological classification, therapeutic approach, novel biomarkers, and follow-up targets in children and adolescents with lupus nephritis.
- |||||||||| Brukinsa (zanubrutinib) / BeiGene
Trial completion date, Monotherapy: ROSEWOOD: A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma (clinicaltrials.gov) - Oct 27, 2023 P2, N=217, Active, not recruiting, This review aims to describe pediatric lupus nephritis and provide an overview of the novel perspectives on the pathogenetic mechanisms, histopathological classification, therapeutic approach, novel biomarkers, and follow-up targets in children and adolescents with lupus nephritis. Trial completion date: Nov 2023 --> Oct 2024
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal: Ulcerative colitis induced by obinutuzumab in a patient treated for a folicular lymphoma. (Pubmed Central) - Oct 26, 2023 An increasing use of immunomodulatory drugs has led to a corresponding increase in treatment-related pathologies such as inflammatory bowel disease. Here, we present a case of ulcerative colitis due to Obinutuzumab, an antiCD20 monoclonal approved for the treatment of Non-Hodgkin lymphomas.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial primary completion date: O-ICE: Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL (clinicaltrials.gov) - Oct 26, 2023 P2, N=25, Recruiting, Here, we present a case of ulcerative colitis due to Obinutuzumab, an antiCD20 monoclonal approved for the treatment of Non-Hodgkin lymphomas. Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| FT596 / Fate Therap
Trial completion date, Trial termination, Trial primary completion date, Combination therapy, Monotherapy: FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies (clinicaltrials.gov) - Oct 26, 2023 P1, N=98, Terminated, Active, not recruiting --> Completed Trial completion date: May 2039 --> Sep 2023 | Active, not recruiting --> Terminated | Trial primary completion date: May 2024 --> Sep 2023; The study was terminated by the Sponsor.
- |||||||||| FT516 / Fate Therap
Trial completion date, Trial termination, Trial primary completion date, Combination therapy, Monotherapy, Metastases: FT516-101: FT516 in Subjects With Advanced Hematologic Malignancies (clinicaltrials.gov) - Oct 26, 2023 P1, N=72, Terminated, Trial completion date: May 2039 --> Sep 2023 | Active, not recruiting --> Terminated | Trial primary completion date: May 2024 --> Sep 2023; The study was terminated by the Sponsor. Trial completion date: May 2039 --> Oct 2023 | Active, not recruiting --> Terminated | Trial primary completion date: May 2024 --> Oct 2023; The study was terminated by the Sponsor.
- |||||||||| cibisatamab (RG7802) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Phase Ib Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Participants With Previously Treated Metastatic Colorectal Adenocarcinoma (clinicaltrials.gov) - Oct 26, 2023 P1, N=47, Active, not recruiting, Trial completion date: May 2039 --> Oct 2023 | Active, not recruiting --> Terminated | Trial primary completion date: May 2024 --> Oct 2023; The study was terminated by the Sponsor. Trial completion date: Oct 2023 --> Mar 2024 | Trial primary completion date: Oct 2023 --> Mar 2024
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal: Posterior Reversible Encephalopathy Syndrome Triggered by Obinutuzumab in a Patient with Chronic Lymphocytic Leukemia. (Pubmed Central) - Oct 24, 2023 MRI findings were consistent with PRES, including diffuse vasogenic cerebral edema predominately throughout the bilateral parietal and occipital lobes associated with some edematous extension into the posterior part of bilateral frontal lobes. This case aims to highlight the importance of early diagnosis by appropriately identifying the MRI features of PRES to improve patient quality of life and decrease morbidity and mortality.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal: Obinutuzumab-Based Drug-Free Macromolecular Therapeutics Synergizes with Topoisomerase Inhibitors. (Pubmed Central) - Oct 15, 2023 We performed cell mechanism experiments to analyze points of synergism or antagonism by investigating Ca influx, mitochondrial health, lysosomal stability, and cell cycle arrest. Finally, we demonstrated the synergistic drug combinatorial effects of OBN-based DFMT with etoposide in vivo using a human xenograft non-Hodgkin's lymphoma mouse model.
- |||||||||| Monjuvi (tafasitamab-cxix) / Incyte, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Enrollment open: Tafasitamab, Acalabrutinib, and Obinutuzumab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Oct 10, 2023 P1, N=25, Recruiting, Phase classification: P1 --> P1/2 Not yet recruiting --> Recruiting
- |||||||||| Columvi (glofitamab-gxbm) / Roche, Polivy (polatuzumab vedotin-piiq) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
New P2 trial, CAR T-Cell Therapy: PORTAL: A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab as a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma (clinicaltrials.gov) - Oct 9, 2023 P2, N=99, Not yet recruiting,
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rydapt (midostaurin) / Novartis
SM-AHN presenting as SLL (Hall G) - Sep 30, 2023 - Abstract #DGHO2023DGHO_1462; Diagnosis of SLL should be accompanied by a lymph node biopsy in uncommon cases with punctio sicca, and SM should always be suspected in patients with unexplained lymphadenopathy, hepatomegaly and/or splenomegaly and rapidly declining condition. In such cases, tryptase levels can help to stir diagnostic work-up into the right direction.
- |||||||||| Darzalex (daratumumab) / J&J, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Myeloid cell-mediated killing of BCP-ALL cells by IgA2 variants of daratumumab, rituximab and obinutuzumab can be enhanced by CD47/SIRP? interference (Hall D) - Sep 30, 2023 - Abstract #DGHO2023DGHO_730; Consequently, combining DARA, RTX or OBI as IgG1 or IgA2 together with CD47/SIRP? checkpoint blockade is worth further evaluation for individualized BCP-ALL immunotherapy.
- |||||||||| Columvi (glofitamab-gxbm) / Roche, RG6333 / Roche
Trial completion date, Trial primary completion date, Combination therapy: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov) - Sep 28, 2023 P1, N=200, Recruiting, Overall, this analysis does not demonstrate a benefit of adding Pola to BR or BG regimens for patients with R/R FL. Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2024 --> Apr 2025
- |||||||||| Columvi (glofitamab-gxbm) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
New P2 trial: Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov) - Sep 26, 2023 P2, N=40, Not yet recruiting,
- |||||||||| MODULE 2: Novel Strategies Combining Bruton Tyrosine Kinase (BTK) and Bcl-2 Inhibitors in CLL (Omni San Diego, Grand Ballroom (Level 2), 4) - Sep 23, 2023 - Abstract #ASH2023ASH_264;
Supported by educational grants from AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Bristol Myers Squibb, and Lilly. Mechanistic rationale for combining BTK and Bcl-2 inhibitors with or without anti-CD20 antibodies in the management of CLL Long-term efficacy and safety outcomes from early-phase studies evaluating ibrutinib in combination with venetoclax for patients with treatment-na
- |||||||||| MODULE 1: Evolving Role of Novel Treatment Strategies in Follicular Lymphoma (FL) (Omni San Diego, Grand Ballroom (Level 2), 4) - Sep 23, 2023 - Abstract #ASH2023ASH_247;
Supported by educational grants from AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Genentech, a member of the Roche Group, Genmab US Inc, Merck and Seagen Inc. Appropriate integration of obinutuzumab into current FL treatment algorithms Long-term clinical trial findings with lenalidomide/rituximab (R2) among patients with treatment-na
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
B-Cell Recovery in a Randomized Controlled Trial of B-Cell Depletion with Obinutuzumab for the Treatment of Proliferative Lupus Nephritis (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3573; P2 Renal response rates at Week 104 were similar among patients who recovered B cells within 2 years of their final obinutuzumab infusion and those who recovered later or were still depleted, suggesting a greater clinical effect of early sustained depletion vs duration of depletion on clinical response. 1 Within the limitation of small sample size, the SAE and infectious SAE rates appeared similar regardless of the duration of B-cell depletion.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Obinutuzumab Efficacy and Tolerance in Patients with Auto-Immune Diseases Immunized Against Rituximab (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3460; In conclusion, obinutuzumab can be a good therapeutic option for AID patients who are immunized against RTX without symptomatic cross immunogenicity, with good tolerance and with clinical response in half of the patients. Further studies are required to determine which type of patients could respond to this treatment.
- |||||||||| Onureg (azacitidine oral) / BMS, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma (clinicaltrials.gov) - Sep 15, 2023 P1, N=8, Active, not recruiting, Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | N=24 --> 8 | Trial completion date: Apr 2024 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Apr 2024
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