Gazyva (obinutuzumab) / Roche, Biogen 
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 23 Diseases   163 Trials   163 Trials   4765 News 


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  • ||||||||||  Gazyva (obinutuzumab) / Biogen, Roche, Rituxan (rituximab) / Roche, Biogen
    PERSISTENT HYPOGAMMAGLOBULINEMIA FOLLOWING OBINUTUZUMAB TREATMENT FOR CHRONIC LYMPHOCYTIC LEUKEMIA (Monitor 4) -  Nov 9, 2019 - Abstract #ACAAI2019ACAAI_758;    
    Discussion Long-term impact of obinutuzumab on immunoglobulin levels has not been well studied; our case report presents an association with persistent hypogammaglobulinemia and complete peripheral B-cell depletion. Patients who require this anti B-cell monoclonal antibody therapy should have quantitative immunoglobulin levels & B-cell number and function monitored before and after treatment.
  • ||||||||||  cyclophosphamide intravenous / Generic Mfg., Rituxan (rituximab) / Roche, Biogen
    Journal:  The Treatment of Chronic Lymphatic Leukemia. (Pubmed Central) -  Nov 8, 2019   
    Recent progress in the development of novel treatment options gives hope that CLL may soon be a controllable disease. Even at present, chemoimmuno- therapy can achieve a progression-free survival of more than eight years in certain genetically defined subgroups of CLL patients.
  • ||||||||||  A Phase 3 Trial Comparing the Efficacy and Safety of Acalabrutinib in Combination with Venetoclax with or without Obinutuzumab, Compared with Investigator’s Choice of Chemoimmunotherapy in Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) without Del(17p) or TP53 Mutation (Hall B, Level 2 (Orange County Convention Center)) -  Nov 7, 2019 - Abstract #ASH2019ASH_6063;    
    P3
    Recently completed phase 3 trials showed acalabrutinib ± obinutuzumab (obi) improved PFS vs chemotherapy in untreated patients (ELEVATE TN: AstraZeneca Press release 06/06/2019), and acalabrutinib improved PFS vs idelalisib or bendamustine + rituximab in relapsed/refractory patients (ASCEND: Ghia et al...In the phase 3 CLL-14 trial in untreated patients with CLL, fixed duration treatment with obi (6 months) + ven (12 months) was more efficacious than obi (6 months) + chlorambucil (12 months), achieving a longer PFS and higher rate of uMRD (Fischer et al...Study design and ACE-CL-311 (NCT03836261) is a 3-arm phase 3, randomized (1:1:1), global, multicenter, open-label trial evaluating the efficacy and safety of acalabrutinib + ven (Arm A) vs acalabrutinib + ven + obi (Arm B) vs CIT (Arm C: fludarabine/cyclophosphamide/rituximab [FCR; only for patients ≤ 65 years of age] or bendamustine/rituximab [BR])...Key exclusion criteria include stroke or intracranial hemorrhage, significant cardiovascular disease (asymptomatic or controlled atrial fibrillation allowed), bleeding disorders, or a requirement for treatment with warfarin or equivalent vitamin K antagonists or a strong cytochrome P450 inhibitor...The study is powered to achieve ~90% power to detect a hazard ratio of 0.65 in PFS comparing Arm A to Arm C, assuming median PFS of 44.7 months in FCR/BR at the 2-sided significance level of 0.05. Patients will be stratified based on age (>65 vs ≤65 years), IGHV mutational status (mutated vs unmutated), Rai stage risk (high [≥3] vs non-high [<3]), and geographic location (North America vs Europe vs Other).
  • ||||||||||  Rituxan (rituximab) / Roche, Biogen
    IL-21-Expanded NK Cells As Autologous Cell Therapy for CLL (Hall B, Level 2 (Orange County Convention Center)) -  Nov 7, 2019 - Abstract #ASH2019ASH_6048;    
    These patient-derived cells are superior to normal unstimulated NKs and are similar or even better than expanded donor NK cells . Ongoing studies will explore in vivo function of these NK cells, combination with CLL-targeted treatments, and further functional measures .
  • ||||||||||  Rituxan (rituximab) / Roche, Biogen
    IL-21-Expanded Natural Killer Cells As Autologous Cell Therapy for CLL (Hall B, Level 2 (Orange County Convention Center)) -  Nov 7, 2019 - Abstract #ASH2019ASH_6047;    
    These patient-derived cells are superior to normal unstimulated NKs and are similar or even better than expanded donor NK cells . Ongoing studies will explore in vivo function of these NK cells, combination with CLL-targeted treatments, and further functional measures .
  • ||||||||||  Polivy (polatuzumab vedotin) / Roche, Seattle Genetics, Rituxan (rituximab) / Roche, Biogen
    Polatuzumab Vedotin, an Antibody-Drug Conjugate Targeting CD79b, Is a Highly Active Agent Against Burkitt Lymphoma and Primary Mediastinal B-Cell Lymphoma (Hall B, Level 2 (Orange County Convention Center)) -  Nov 7, 2019 - Abstract #ASH2019ASH_5695;    
    The use of short and intense multiagent chemotherapy alone and in combination with rituximab (R) results in ≥90% event-free survival (EFS) in children and adolescents with BL and DLBCL (Cairo et al, JCO, 2012; Goldman/Cairo Leukemia, 2013; BJH, 2014)...We previously demonstrated that Obinutuzumab (O), a new type II anti-CD20 monoclonal antibody, is an active agent against both BL and PMBL (Awasthi/Cairo et al, BJH, 2015)...These preclinical results suggest that PV should be considered for investigation in patients with both recurrent/refractory BL and PMBL and in patients with newly diagnosed disease with either high risk features or those with poor responses to induction therapy . Authors AA, MB & AA are all considered co-primary first authors
  • ||||||||||  rhIL-15 / National Cancer Institute, Gazyva (obinutuzumab) / Biogen, Roche, Rituxan (rituximab) / Roche, Biogen
    Phase 1 Trial of Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocytic Leukemia (Hall B, Level 2 (Orange County Convention Center)) -  Nov 7, 2019 - Abstract #ASH2019ASH_4244;    
    Obinutuzumab is a glycoengineered, humanized type 2 anti-CD20 monoclonal antibody thought to engage the immune system by directly activating antibody- dependent, cell-mediated cytotoxicity (ADCC); it is approved for treatment of chronic lymphocytic leukemia in combination with chlorambucil...Preclinical murine lymphoid malignancy models have shown increased efficacy of monoclonal antibodies when administered together with rhIL-15; BL/6 mice inoculated with EL4-CD20 cells (a syngeneic lymphoma line); including significant prolongation of survival with the IL-15/Rituximab combination compared to either drug given as single agent (90% v...Primary objective: determine the safety, toxicity profile, dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) of civ rhIL-15 administration in combination with obinutuzumab treatment Secondary objectives: 1) evaluate the potential antitumor activity of the combination of rhIL-15 and obinutuzumab by assessing the clinical response rate, minimal residual disease (MRD) status, progression-free survival, and overall survival in patients with relapsed and refractory CLL; 2) define the effects of rhIL-15 on the ADCC mediated by obinutuzumab using ex vivo peripheral blood mononuclear cells (PBMCs); 3) characterize the biological effects of rhIL-15 administered with obinutuzumab on the percentages and absolute numbers of circulating lymphocytes (T and NK cells) and the T- cell subsets (including naïve, central, and effector memory subsets) by flow cytometry Exploratory objectives: identify biomarkers predictive of response to rhIL-15 and obinutuzumab treatment, such as circulating tumor DNA (ctDNA) and baseline cytokine levels Eligibility criteria: 1) age ≥ 18 years; 2) ECOG ≤ 1; 3) Diagnosis of CLL or small lymphocytic lymphoma (SLL) with ≥ 50% of B cells expressing CD20; 4) measurable or evaluable disease that is refractory or relapsed following therapy with a BTK inhibitor OR have relapsed/refractory CLL and are intolerant to BTK inhibitor therapy; patients with del(17p) must also be refractory or relapsed after, or intolerant to, therapy with venetoclax; 5) adequate organ function parameters as defined within the protocol; 6) active disease requiring treatment, as defined within the protocol...One patient has started treatment to date . Enrollment is ongoing.
  • ||||||||||  BTK and/or PLCG2 Mutations in Patients with Chronic Lymphocytic Leukemia (CLL) Treated with Ibrutinib: Characteristics and Outcomes at the Time of Progression (Hall B, Level 2 (Orange County Convention Center)) -  Nov 7, 2019 - Abstract #ASH2019ASH_4242;    
    Therapy following progression on ibrutinib in these pts was as follows: venetoclax (n=16; 11 pts who continued ibrutinib in combination), idelalisib (n=4), investigational treatments (n=2), continued ibrutinib alone (n=2), dose-adjusted EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab; n=1), and unknown (n=1)...Treatment of these patients consisted of the following: restarted ibrutinib in addition to current treatment of venetoclax (n=5), venetoclax (n=2), pembrolizumab (n=2; 1 pt with continued ibrutinib), obinutuzumab with continued ibrutinib (n=1), gemcitabine and vinorelbine with continued ibrutinib (n=1), and no further treatment (n=1)...Treatments following progression on ibrutinib included multi-agent chemoimmunotherapy (n=3; 2 pts received rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone [R-CHOP] with continued ibrutinib and 1 pt received doxorubicin, bleomycin, vinblastine, dacarbazine [ABVD] alone), pembrolizumab (n=3; 1 pt in combination with continued ibrutinib), venetoclax in combination with continued ibrutinib (n=1), and venetoclax and obinutuzumab (n=1)...CONCLUSION Approximately 60% of pts tested in this progression cohort had a BTK or PLCG2 mutation at time of or preceding progression on ibrutinib therapy. OS and time to next therapy did not differ statistically between pts with mutated vs non-mutated clones; however, caution should be applied with the conclusions given the limited sample size.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie
    Debulking Eliminates Need for Hospitalization Prior to Initiating Frontline Venetoclax Therapy in Previously Untreated CLL Patients: A Phase 3b Study (Hall B, Level 2 (Orange County Convention Center)) -  Nov 7, 2019 - Abstract #ASH2019ASH_4234;    
    P3b
    Two cycles of obinutuzumab prior to initiation of venetoclax was an effective debulking strategy for patients with ALC >25 × 109 /L and lymph nodes 5 cm treated with obinutuzumab or >10 cm treated with obinutuzumab plus bendamustine may need >2 cycles to achieve low tumor burden. Debulking via obinutuzumab, with or without bendamustine, may allow more patients to be administered venetoclax in the outpatient setting, eliminating the need for hospitalization during venetoclax initiation.
  • ||||||||||  Rituxan (rituximab) / Roche, Biogen, Imbruvica (ibrutinib) / AbbVie, J&J
    Maintenance of Long-Term Undetectable Minimal Residual Disease after Combination of Ibrutinib with Abbreviated Chemotherapy in the Icll-07 Filo Trial (Hall B, Level 2 (Orange County Convention Center)) -  Nov 7, 2019 - Abstract #ASH2019ASH_4230;    
    P2
    Introduction In previously untreated, medically fit patients with chronic lymphocytic leukaemia (CLL) and no 17p deletion, there is current research interest in improving survival outcomes and potentially sparing some patients from the standard 6 cycles of fludarabine, cyclophosphamide and rituximab (FCR)...Otherwise, patients received 4x4‑weekly cycles of fludarabine/cyclophosphamide (FC) and obinutuzumab 1000 mg iv, alongside continuing ibrutinib for 6 additional months (FCGA+I arm)...With longer follow-up, including assessing the evolution of PB MRD, the response is maintained. This strategy could be an option in the first‑line setting, although randomised trial evidence is needed.
  • ||||||||||  Rituxan (rituximab) / Roche, Biogen
    Recapitulation of Prognostic Mutational Subtyping Utilizing F1H in GOYA and CAVALLI and the Potential to Highlight Benefit of Targeted Therapy in De Novo DLBCL (Hall B, Level 2 (Orange County Convention Center)) -  Nov 7, 2019 - Abstract #ASH2019ASH_3966;    
    P1/2, P3
    Important findings from the present work include: 1) utility of targeted mutational data from F1H in recapitulating molecular clusters, previously identified using WES, that further subclassify established prognostic groups such as COO and IPI; and 2) a trend towards improved survival outcomes for patients in the BCL2/EZH2 cluster upon treatment with the BCL2 inhibitor venetoclax . This highlights the potential for utilizing novel genetic signatures as a means of identifying patients suitable for targeted therapies in the era of personalized health care.