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162 Trials |
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- EUROFLOW STANDARDIZATION TECHNIQUE AND NORMALIZATION PROCEDURES IN LONGITUDINAL FLOW CYTOMETRIC EXPRESSION ANALYSIS OF CD20 IN CLL PATIENTS RECEIVING ANTI-CD20 DIRECTED THERAPY () - May 13, 2022 - Abstract #EHA2022EHA_1267;
Conclusion Following standardized staining and instrument monitoring, it should be possible to robustly assess longitudinal biological variations of marker expression based on MFI values. In a cross trial comparison Obinutzumab showed highest proportion of patients with strong MRD response independent from initial CD20 expression, whereas strong response to Ofatumumab seems to correlate with higher CD20 expression levels.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
UPDATED RESULTS OF A PHASE 1B STUDY OF IBRUTINIB (IBR) PLUS OBINUTUZUMAB (OBIN) IN PATIENTS WITH RELAPSED OR REFRACTORY (R/R) CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) () - May 13, 2022 - Abstract #EHA2022EHA_1265;
P1
With ~3.5 yrs median follow-up, and some pts on tx over 6 yrs, cardiotoxicity was consistent with prior ibr studies, and no new safety concerns have emerged. Our data support continued exploration of combination BTK inhibitor plus obin in R/R CLL.
- Calquence (acalabrutinib) / AstraZeneca
LONG-TERM EFFICACY OF ACALABRUTINIB-BASED REGIMENS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND HIGHER-RISK GENOMIC FEATURES: POOLED ANALYSIS OF CLINICAL TRIAL DATA () - May 13, 2022 - Abstract #EHA2022EHA_1252;
Conclusion In this pooled analysis of clinical trial data in 801 CLL pts with higher-risk genomic features, efficacy of A-based regimens led to high PFS and OS rates at a median follow-up of nearly 4 y. The safety profile in this analysis was similar to the overall safety profile of acalabrutinib. Our results demonstrate the long-term benefit of A-based regimens in CLL pts with higher-risk genomic features, regardless of line of therapy.
- Calquence (acalabrutinib) / AstraZeneca
CARDIAC ADVERSE EVENTS AND SECOND PRIMARY MALIGNANCIES WITH ACALABRUTINIB IN CHRONIC LYMPHOCYTIC LEUKEMIA -A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS () - May 13, 2022 - Abstract #EHA2022EHA_1251;
In the ELEVATE -TN study, the comparator arm included the combination of chlorambucil and Obinutuzumab...Conclusion There is no increase in risk of atrial fibrillation with the acalabrutinib based regimens as compared to the non-acalabrutinib – based therapies; however, there was a significantly increased risk of HTN. There is lower risk of SPM and non-melanoma SPM in the acalabrutinib based regimens than the control arm.
- Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
RETREATMENT WITH VENETOCLAX AFTER VENETOCLAX, OBINUTUZUMAB +/- IBRUTINIB: POOLED ANALYSIS OF 13 PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) TREATED IN GCLLSG TRIALS () - May 13, 2022 - Abstract #EHA2022EHA_1232;
Current clinical trials also combine Ven-G with ibrutinib (GIVe) or acalabrutinib (GAVe) to increase efficacy and possibly shorten treatment duration with minimal residual disease (MRD)-guided discontinuation strategies...V2 was GAVe in 9 pts, including 2 with a bendamustine debulking, and Ven-G or Ven in 2 each, all with a MRD-guided discontinuation...1. Conclusion In this pooled analysis of 13 pts with two consecutive time-limited V-containing therapies, which includes mainly pts with adverse risk factors and a short remission duration, V-based re-treatment appeared to be safe and efficacious: no increased rate of AEs was seen so far and all pts responded with at least 2/3 even achieving uMRD again.
- FRONTLINE THERAPY CLL WITHOUT 17P DEL/P53 ABERRATIONS: SYSTEMATIC REVIEW AND BAYESIAN NETWORK META-ANALYSIS () - May 13, 2022 - Abstract #EHA2022EHA_1228;
The combination ACA-O has the highest probability to be the best treatment for prolonging the PFS in untreated, UN/MU-only CLL patients. ACA monotherapy is a valuable alternative considering both the safety and efficacy profile.
- Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
EFFICACY OF FIRST-LINE TREATMENT FOR CHRONIC LYMPHOCYTIC LEUKEMIA: A BAYESIANNETWORK META-ANALYSIS. () - May 13, 2022 - Abstract #EHA2022EHA_1224;
P3, P4
Results from this indirect treatment comparison suggested that the PFS for zanubrutinib may be statistically significantly better than immunochemotherapy. Findings from this study require validation with further large scale RCTs with longer follow up time.
- Calquence (acalabrutinib) / AstraZeneca
TIME-LIMITED TREATMENT WITH ACALABRUTINIB PLUS OBINOTUZUMAB IN TREATMENT-NAÏVE CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS INDUCES DEEP REMISSIONS: EARLY RESULTS OF AN ONGOING PHASE 2 TRIAL. () - May 13, 2022 - Abstract #EHA2022EHA_1220;
P2
Conclusion Our preliminary data indicate that combination therapy of acalabrutinib plus obinotuzumab induces remissions with a major reduction in bone marrow disease after 6 months of combination therapy. Longer treatment and follow-up is warranted to determine the durability of responses after therapy discontinuation.
- ADJUSTING SURVIVAL DATA FOR TREATMENT CROSSOVER IN THE ELEVATE-TN TRIAL BY USING A HISTORICAL COHORT OF PATIENTS TREATED WITH CHEMOIMMUNOTHERAPY IN FRONT-LINE CHRONIC LYMPHOCYTIC LEUKEMIA () - May 13, 2022 - Abstract #EHA2022EHA_1214;
ELEVATE-TN trial interim data (~47 months median follow-up [FU]) did not show survival benefit for A±obinutuzumab (O) versus chlorambucil+obinutuzumab (C+O) despite significantly superior progression-free survival (PFS)...Methods The CLL11 trial demonstrated superior PFS and OS for C+O versus C and C+rituximab in first-line CLL prior to BTKi availability...Conclusion The non-statistically significant OS for A±O versus C+O was likely due to treatment crossover. Conducting a treatment-switching analyses was challenging due to immature OS data; however, this analysis supports the hypothesis that crossover to A bolstered ELEVATE-TN C+O OS.
- Calquence (acalabrutinib) / AstraZeneca
ACALABRUTINIB RELATED INFECTIOUS COMPLICATIONS-A SYSTEMATIC REVIEW AND META-ANALYSIS OF PHASE III RCT () - May 13, 2022 - Abstract #EHA2022EHA_1213;
In the ELEVATE -TN study the comparator arm included the combination of chlorambucil and obinutuzumab...We noted a substantial heterogeneity across trials included in our analysis. Conclusion Our meta-analysis demonstrated that patients on acalabrutinib-containing regimens experienced a significantly lower relative risk of infections compared to non-acalabrutinib-based therapies. There were significantly lower risks of URTI and infection related treatment discontinuations with acalabrutinib therapy in patients with CLL.
- Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
RESPONSE TO NOVEL ANTI CD20 ANTIBODY AND BCL2 INHIBITOR IN A PATIENT WITH CLL AND MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS ASSOCIATED WITH LEUKEMIC KIDNEY INFILTRATION AND REVIEW OF LITERATURE () - May 13, 2022 - Abstract #EHA2022EHA_1203;
Until today the patient followed 4 cycles of OV with complete remission of CLL and complete response of his underlying MPGN and leukemic renal infiltration. Conclusion Of all the cases in the literature, our approach to this condition was different, choosing Obinutuzumab and Venetoclax therapy, obtaining the complete response after the first cycle.
- Venclexta (venetoclax) / Roche, AbbVie
BCL2 RESISTANCE MUTATIONS IN A REAL-WORLD COHORT OF PATIENTS WITH VENETOCLAX-TREATED CHRONIC LYMPHOCYTIC LEUKAEMIA () - May 13, 2022 - Abstract #EHA2022EHA_1177;
In patients harboring multiple BCL2 mutations, convergent evolution of the CLL subclones may contribute to the driver mechanisms of resistance, justifying the comprehensive approach for the detection of these variants. In secondary venetoclax resistant cases displaying wild type BCL2 , further molecular screening methods are required to reveal alternative genetic or non-genetic reasons for disease progression.
- Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
CLINICOBIOLOGICAL CHARACTERISTICS AND TREATMENT EFFICACY OF NOVEL AGENTS IN CHRONIC LYMPHOCYTIC LEUKEMIA WITH IGLV3-21R110 () - May 13, 2022 - Abstract #EHA2022EHA_1171;
Our results suggest that novel targeted therapies may mitigate the adverse risk profile of IGLV3-21 R110 CLL. To determine whether these patients should preferentially receive novel therapies, characterization of the predictive impact of IGLV3-21 R110 in the setting of chemoimmunotherapy is warranted.
- glofitamab (RG6026) / Roche
REAL-WORLD EXPERIENCE OF OUTCOMES WITH GLOFITAMAB SALVAGE THERAPY FOR RELAPSE/REFRACTORY B-CELL LYMPHOMA IN TAIWAN: MINIMAL SAFETY CONCERN WITH HEPATITIS B REACTIVATION () - May 13, 2022 - Abstract #EHA2022EHA_1059;
The treatment protocol included obinutuzumab pretreatment 1000mg given 7 days before the first glofitamab dose, followed by step-up dose of glofitamab administration: 2.5mg on Day 1 and 10mg on Day 8 of cycle 1, and then 30mg on Day 1 of cycle 2-12 (21-day cycles)...All patients had received prior rituximab therapy, 6(23%), autologous or allogeneic stem cell transplantation (SCT), and 9(35%), polatuzumab salvage...No new safety issues were observed. With optimal prophylaxis, the risk of HBV reactivation would not be of concern during glofitamab treatment.
- glofitamab (RG6026) / Roche
IMMUNE CORRELATES OF RESPONSE TO GLOFITAMAB: BIOMARKER FINDINGS FROM A PIVOTAL PHASE II EXPANSION STUDY IN PATIENTS WITH RELAPSED OR REFRACTORY (R/R) DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) () - May 13, 2022 - Abstract #EHA2022EHA_1039;
P1/2
Several novel response-associated biomarkers were identified in PB including higher BL B cell, CD4, and CD4 EM counts in responders and higher PD1 expression on CD8 in pts with PD. These data suggest a model where the clinical activity of glofitamab may be dependent upon immune contexture in the tumor and PB at the start of treatment.
- OUTCOMES OF COVID-19 INFECTION IN PATIENTS WITH B AND PLASMA CELL MALIGNANCIES DURING THE THIRD WAVE IN ARGENTINA: A SINGLE CENTER EXPERIENCE () - May 13, 2022 - Abstract #EHA2022EHA_1570;
Nearly half of the pts had received a B-cell-depleting monoclonal antibody-based regimen: Rituximab (n=13), Daratumumab (n=4) or Obinutuzumab (n=1); the other half: other anti-myeloma therapy (n=5), chemotherapy (n=3), Ibrutinib (n=3), Venetoclax (n=2) or were untreated (n=7)...Twelve pts were treated with convalescent plasma, 9 received corticosteroids and 1 tocilizumab...Our findings show lower fatality rate than reported in previous waves, but still higher than the general vaccinated population. This might be explained because even if fully vaccinated, responsive patients fail to achieve protective levels of anti-spike antibodies.
- Arzerra (ofatumumab) / Novartis, Genmab, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
The use of Obinutuzumab and Ofatumumab in the treatment of immune Thrombotic Thrombocytopenic Purpura (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_842;
21/26 episodes were pre-emptive treatment in ADAMTS13 relapses, 4/26 episodes were as part of treatment for clinical relapses and 1/26 episode was during the acute presentation period. All patients had previously received rituximab but was clinically felt inappropriate for further treatments - 12/15 had rituximab-induce serum sickness, 1/15 had acute drug intolerance and 2/15 had short duration of response to rituximab.
- || Keytruda (pembrolizumab) / Merck (MSD)
Clinical, Journal: Pembrolizumab treatment of inflammatory progressive multifocal leukoencephalopathy: a report of two cases. (Pubmed Central) - May 12, 2022
We present two cases of non-HIV, non-MS patients with PML who were treated with pembrolizumab with little clinical benefit. The literature surrounding pembrolizumab use in PML is discussed, with a focus on potential indicators of successful outcomes for patients who receive this therapy.
- |||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Enrollment open: A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL (clinicaltrials.gov) - May 10, 2022
P3, N=650, Recruiting, Sponsor: German CLL Study Group
The literature surrounding pembrolizumab use in PML is discussed, with a focus on potential indicators of successful outcomes for patients who receive this therapy. Not yet recruiting --> Recruiting
- | Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, magrolimab (GS-4721) / Ono Pharma
Enrollment open: Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies (clinicaltrials.gov) - May 9, 2022
P1, N=76, Recruiting, Sponsor: National Cancer Institute (NCI)
Not yet recruiting --> Recruiting Suspended --> Recruiting
- || Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Otsuka, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Review, Journal: Innovations in the pharmaceutical treatment of systemic lupus erythematosus (Pubmed Central) - May 6, 2022
New and innovative treatment concepts are finding their way into lupus treatment and other promising substances are in the pipeline; however, only long-term data will show to what extent these improve the long-term outcome of patients. Nevertheless, these are important and much needed advances in the treatment of SLE.
- || Columvi (glofitamab-gxbm) / Roche, Rituxan (rituximab) / Roche
New P1 trial, 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) - May 6, 2022
P1, N=40, Not yet recruiting, Sponsor: Hoffmann-La Roche
- | golcadomide (CC-99282) / BMS
Trial primary completion date, Combination therapy: A Safety and Preliminary Efficacy Study of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (clinicaltrials.gov) - May 5, 2022
P1b, N=50, Recruiting, Sponsor: Celgene
Nevertheless, these are important and much needed advances in the treatment of SLE. Trial primary completion date: Jun 2024 --> Nov 2024
- || Review, Journal: Strategies for Glycoengineering Therapeutic Proteins. (Pubmed Central) - May 3, 2022
This article provides illustrative examples of drugs that have already been improved through glycoengineering including cytokines exemplified by erythropoietin (EPO), enzymes (ectonucleotide pyrophosphatase 1, ENPP1), and IgG antibodies (e.g., afucosylated Gazyva, Poteligeo, Fasenra™, and Uplizna). In the future, the deliberate modification of therapeutic protein glycosylation will become more prevalent as glycoengineering strategies, including sophisticated computer-aided tools for "building in" glycans sites, acceptance of a broad range of production systems with various glycosylation capabilities, and supplementation methods for introducing non-natural metabolites into glycosylation pathways further develop and become more accessible.
- ||| Brukinsa (zanubrutinib) / BeiGene
Enrollment open: ARIADNE: Zanubrutinib in Patients With Waldenstr (clinicaltrials.gov) - May 3, 2022
P=N/A, N=150, Recruiting, Sponsor: iOMEDICO AG
In the future, the deliberate modification of therapeutic protein glycosylation will become more prevalent as glycoengineering strategies, including sophisticated computer-aided tools for "building in" glycans sites, acceptance of a broad range of production systems with various glycosylation capabilities, and supplementation methods for introducing non-natural metabolites into glycosylation pathways further develop and become more accessible. Not yet recruiting --> Recruiting
- || Avastin (bevacizumab) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal: TRAIL Score: A Simple Model to Predict Immunochemotherapy Tolerability in Patients With Diffuse Large B-Cell Lymphoma. (Pubmed Central) - Apr 30, 2022
Not yet recruiting --> Recruiting TRAIL may be useful as a clinical decision support tool for treatment decisions in patients with DLBCL who may not tolerate standard chemoimmunotherapies.
- Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Efficacy of first-line treatment for chronic lymphocytic leukemia: A Bayesian network meta-analysis. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_6237;
P3, P4
Results from this indirect treatment comparison suggested that the PFS for zanubrutinib may be statistically significantly better than immunochemotherapy. Findings from this study require validation with further large scale RCTs with longer follow up time.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical impact of SARS-CoV-2 delta variant infection in tumor patients and the impact of vaccination on different cancer treatment regimens. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_6154;
In this period, a total of 1.227 patients were tested for SARS-CoV-2 by RT-qPCR. 78/1227 patients (6.3%) were tested positive in RT-qPCR and most showed mild symptoms of infection.
- glofitamab (RG6026) / Roche
Glofitamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and ≥ 2 prior therapies: Pivotal phase II expansion results. (Available On Demand) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5335;
P1/2
Fixed-duration glofitamab induces durable complete remissions and has favorable safety in pts with R/R DLBCL and ≥2 prior therapies, including those with prior exposure to CAR-Ts. Glofitamab is a promising new therapy for pts with heavily pretreated and/or highly refractory DLBCL.
- ibrutinib / Generic mfg.
Characteristics and clinical outcomes among patients receiving either ibrutinib or anti-CD20 monotherapy as first-line (1L) treatment for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): A retrospective analysis in community oncology practice. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_4342;
Despite ibrutinib established as a preferred first-line (1L) treatment option, anti-CD20 monotherapy (rituximab or obinutuzumab) has been prescribed as symptomatic or palliative therapy. IPTW-adjusted analysis showed that in the real-world community practice setting, treatment with ibrutinib resulted in a statistically significantly lower risk of initiating subsequent treatment than the anti-CD20 group including patients with high cytogenetic risk features and without IGHV testing.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Outcome of follicular lymphoma (FL) patients in maintenance with antiCD20 monoclonal antibodies (MoAb) in SARS-Cov2 era. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2733;
A trend in lower mortality is suggested. No differences in terms of relapse rate were observed, but longer follow up is needed.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Tecentriq (atezolizumab) / Roche
Frontline treatment of follicular lymphoma with atezolizumab and obinutuzumab, with and without radiotherapy (The FLUORO study). (Available On Demand; 235a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2692;
P2
Overall response rates (ORR) to standard chemoimmunotherapy (bendamustine or CHOP with rituximab or obinutuzumab) approximate 85% with considerable toxicity (grade 3-5 in 69-75%) (Hiddemann 2018)...Our phase II ‘1st FLOR’ study, combining nivolumab + rituximab in treatment naïve FL yielded 92% ORR, (54% Complete Response, CR)...Sample size is 46 according to a Simon’s 2-stage design. If ≥5 positive responses (CR +/- PR) without prohibitive toxicity are seen in the first 15 pts, 31 further pts will be recruited.The trial has currently enrolled 7 pts from 4 Australian sites.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Long-term outcomes and circulating tumor DNA analysis from a phase I/II study of lenalidomide and obinutuzumab with CHOP for newly diagnosed diffuse large B-cell lymphoma. (Available On Demand; 206) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2659;
P1/2
LOCHOP demonstrates high efficacy and tolerability in newly diagnosed DLBCL, leading to a high rate of undetectable minimal residual disease by ctDNA. Noninvasive molecular subtyping is feasible as a supplement to tissue diagnosis and should be incorporated in future studies aiming to improve on RCHOP.
- Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Four-year follow-up from a phase 2 study of obinutuzumab, ibrutinib, and venetoclax in CLL. (Available On Demand; 193) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2646;
P1/2
At extended follow-up, remissions remain durable after fixed duration OBIN, IBR, and VEN. The efficacy and acceptable safety justify further study and are being compared to IBR and OBIN in 2 phase 3 US cooperative group trials.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Acalabrutinib ± obinutuzumab versus obinutuzumab + chlorambucil in treatment-naïve chronic lymphocytic leukemia: Five-year follow-up of ELEVATE-TN. (Available On Demand; 192) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2645;
P3
The efficacy and acceptable safety justify further study and are being compared to IBR and OBIN in 2 phase 3 US cooperative group trials. After a 5-y follow-up, efficacy and safety of A+O and A monotherapy were maintained, with significantly longer OS in the A+O arm compared with O+Clb.
- Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Zanubrutinib plus obinutuzumab (ZO) versus obinutuzumab (O) monotherapy in patients (pts) with relapsed or refractory (R/R) follicular lymphoma (FL): Primary analysis of the phase 2 randomized ROSEWOOD trial. (Available On Demand; 164) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2613;
P2
ZO demonstrated superior efficacy to O in treatment of pts with R/R FL. ZO had a favorable benefit-risk profile and represents a potential combination therapy for pts with R/R FL.
- || glofitamab (RG6026) / Roche
PK/PD data, Preclinical, Journal: Novel In Vivo and In Vitro Pharmacokinetic/Pharmacodynamic-Based Human Starting Dose Selection for Glofitamab. (Pubmed Central) - Apr 26, 2022
P1/2
FIH starting dose (5 µg) was selected based on IL-6 release considering the markedly higher glofitamab in vitro potency in human vs monkey blood. This is a novel PKPD-based approach for selection of FIH starting dose for a CD20xCD3 bispecific antibody in B-cell lymphoma, evidenced in the glofitamab study, NP30179 (NCT03075696).
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Real-World Experience of Rapid Obinutuzumab Administration: Time to Change Obinutuzumab Infusion Rates () - Apr 25, 2022 - Abstract #BSH2022BSH_105;
Rapid obinutuzumab infusions are well tolerated in selected patients from cycle 2 onwards and this change in practice has the potential to lead to meaningful improvements to chemotherapy unit capacity during this period of persistent strain on healthcare systems. We advocate for review of obinutuzumab administration guidance for lower-risk patients in light of growing evidence to demonstrate the safety and utility of rapid infusions.
- ||| Zynlonta (loncastuximab tesirine-lpyl) / Overland ADCT BioPharma
Enrollment open, Combination therapy: LOTIS 7: A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7) (clinicaltrials.gov) - Apr 24, 2022
P1b, N=200, Recruiting, Sponsor: ADC Therapeutics S.A.
We advocate for review of obinutuzumab administration guidance for lower-risk patients in light of growing evidence to demonstrate the safety and utility of rapid infusions. Not yet recruiting --> Recruiting
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
PHASE II TRIAL OF OBINUTUZUMAB AND ICE CHEMOTHERAPY IN RELAPSED MATURE B-CELL NON-HODGKIN LYMPHOMA () - Apr 20, 2022 - Abstract #ASPHO2022ASPHO_335;
P2
In this phase 2 study, the addition of obinutuzumab to standard salvage chemotherapy has been well tolerated in 6 patients, with the absence of grade 3 or higher adverse events, and 5 patients successfully proceeding to HSCT. Recruitment is ongoing.
- | Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal: Early investigations into improving bowel and bladder function in fetal ovine myelomeningocele repair. (Pubmed Central) - Apr 20, 2022
Ovine fetal MMC repair augmented with PMSC-ECM results in near-normal bowel and bladder function. Further work is needed to evaluate these outcomes in human patients.
- | Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Development of an SPR-based binding assay for characterization of anti-CD20 antibodies to CD20 expressed on extracellular vesicles. (Pubmed Central) - Apr 20, 2022
The detailed binding kinetics information may also contribute to a better understanding of the interaction between these two antibodies and CD20. Moreover, our method provides a platform with which to characterize other therapeutic antibodies binding to EV-expressed membrane proteins.
- || Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: Obinutuzumab, Venetoclax, and Lenalidomide in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - Apr 20, 2022
P1, N=22, Active, not recruiting, Sponsor: Beth Christian
Moreover, our method provides a platform with which to characterize other therapeutic antibodies binding to EV-expressed membrane proteins. Recruiting --> Active, not recruiting | N=60 --> 22 | Trial completion date: Jan 2022 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2022
- ||||| Calquence (acalabrutinib) / AstraZeneca
Trial completion date, Trial initiation date, Trial primary completion date: MAJIC: A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - Apr 20, 2022
P3, N=600, Not yet recruiting, Sponsor: AstraZeneca
Recruiting --> Active, not recruiting | N=60 --> 22 | Trial completion date: Jan 2022 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2022 Trial completion date: Sep 2028 --> Jun 2029 | Initiation date: Mar 2022 --> Jun 2022 | Trial primary completion date: Sep 2028 --> Jun 2029
- | Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
New P2 trial, Combination therapy: Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Apr 20, 2022
P2, N=52, Not yet recruiting, Sponsor: Ohio State University Comprehensive Cancer Center
- | Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal: Obinutuzumab plus lenalidomide (GALEN) in advanced, previously untreated follicular lymphoma in need of systemic therapy. (Pubmed Central) - Apr 19, 2022
P1/2
Except for neutropenia, the safety profile of the combination is remarkable. The study was registered with ClinicalTrials.gov, number NCT01582776.
- | Yinuokai (orelabrutinib) / InnoCare, Biogen, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment open: CWCLL-001: Orelabrutinib and Obinutuzumab Plus FC Regimen in Treating Newly Diagnosed CLL/SLL (clinicaltrials.gov) - Apr 19, 2022
P2, N=25, Recruiting, Sponsor: The First Affiliated Hospital with Nanjing Medical University
The study was registered with ClinicalTrials.gov, number NCT01582776. Not yet recruiting --> Recruiting
- | bendamustine / Generic mfg.
Journal: Late-onset complications with bendamustine versus CHOP or CVP based chemoimmunotherapy in indolent Non-Hodgkin's lymphoma. (Pubmed Central) - Apr 15, 2022
Many patients receiving bendamustine did not have lymphocyte recovery even three years following administration. Ongoing infection prophylaxis with bendamustine-based regimens may offset translation of these laboratory findings to late-onset infectious risk.
- | Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Late onset neutropenia after rituximab and obinutuzumab treatment - characteristics of a class-effect toxicity. (Pubmed Central) - Apr 15, 2022
Febrile neutropenia was uncommon during LON and occurred in 15 patients (4.5%; rituximab (n = 14) and obinutuzumab (n = 1).These data suggest that LON after obinutuzumab treatment is as common as with rituximab. The similarities in LON after rituximab and obinutuzumab argue for a possible class effect for anti-CD20 monoclonal antibodies.
- || Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal: Safe administration of obinutuzumab to rituximab-intolerant patients. (Pubmed Central) - Apr 15, 2022
The similarities in LON after rituximab and obinutuzumab argue for a possible class effect for anti-CD20 monoclonal antibodies. No abstract available