Gazyva (obinutuzumab) / Roche, Biogen 
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 23 Diseases   162 Trials   162 Trials   4758 News 


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  • ||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Review, Journal:  Frontline therapies for untreated chronic lymphoid leukemia. (Pubmed Central) -  Aug 22, 2019   
    Frontline therapy of patients with untreated CLL appears to be shifting from chemotherapy to chemotherapy-free regimens. This review summarized latest development for frontline therapies of untreated CLL.
  • ||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche, ibrutinib / Generic mfg.
    Clinical, P3 data, Journal, IO biomarker:  Single-agent ibrutinib versus chemoimmunotherapy regimens for treatment-naïve patients with chronic lymphocytic leukemia: a cross-trial comparison of phase 3 studies. (Pubmed Central) -  Aug 21, 2019   
    CIT regimens included: fludarabine + cyclophosphamide + rituximab (CLL8, CLL10), bendamustine + rituximab (CLL10), obinutuzumab + chlorambucil and rituximab + chlorambucil (CLL11), and ofatumumab + chlorambucil (COMPLEMENT-1)...Although definitive conclusions cannot be made due to inherent limitations of cross-trial comparisons, this report suggests that ibrutinib has a favorable benefit/risk profile and may potentially eliminate the need for chemotherapy in some patients. Randomized, comparative studies are needed to support these findings.
  • ||||||||||  Calquence (acalabrutinib) / AstraZeneca
    Trial completion date, Combination therapy, Monotherapy:  ELEVATE-TN: Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment na (clinicaltrials.gov) -  Aug 21, 2019   
    P3,  N=535, Active, not recruiting, 
    Randomized, comparative studies are needed to support these findings. Trial completion date: May 2020 --> Jul 2021
  • ||||||||||  Calquence (acalabrutinib) / AstraZeneca
    Trial primary completion date, Combination therapy, Monotherapy:  ELEVATE-TN: Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment na (clinicaltrials.gov) -  Aug 20, 2019   
    P3,  N=535, Active, not recruiting, 
    Trial completion date: May 2020 --> Jul 2021 Trial primary completion date: Dec 2019 --> Feb 2019
  • ||||||||||  Gazyva (obinutuzumab) / Biogen, Roche, Calquence (acalabrutinib) / AstraZeneca
    Acalabrutinib with Obinutuzumab in Treatment-Naive (TN) and Relapsed/Refractory (R/R) Patients with Chronic Lymphocytic Leukemia (CLL): 3-Year Follow-Up (Chronic Lymphocytic Leukemia) -  Aug 18, 2019 - Abstract #SOHO2019SOHO_170;    
    P1b
    Common Grade 3/4 AEs were decreased neutrophil count (24%), syncope (11%), decreased platelet count, increased weight, and cellulitis (9% each). There were two (4%) Grade 3 bleeding events (hematuria and muscle hemorrhage) and one (2%) Grade 3 atrial fibrillation event.Conclusions Acalabrutinib plus obinutuzumab was well tolerated and yielded high response rates that were durable and deepened over time in TN and R/R CLL patients.Funding Acerta Pharma, a member of the AstraZeneca Group (NCT02296918).
  • ||||||||||  Rituxan (rituximab) / Roche, Biogen
    Clinical, Review, Journal:  BENDAMUSTINE: AN OLD DRUG IN THE NEW ERA FOR PATIENTS WITH NON-HODGKIN LYMPHOMAS AND CHRONIC LYMPHOCYTIC LEUKEMIA. (Pubmed Central) -  Aug 17, 2019   
    In relapsed setting, the addition of ibrutinib to B-R has shown superior results compared to B-R alone, possibly changing the paradigm of treatment of relapsed CLL. In conclusion, bendamustine as a single agent or in combinations has shown activity with acceptable toxic profile in the treatment of patients with indolent NHLs or CLL without del(17p) mutation.
  • ||||||||||  Calquence (acalabrutinib) / AstraZeneca
    Journal:  Acalabrutinib and its use in treatment of chronic lymphocytic leukemia. (Pubmed Central) -  Aug 15, 2019   
    ...To date, ibrutinib is the only Bruton tyrosine kinase (BTK) inhibitor that's approved for treatment of CLL...The most common adverse effects (>20%) were grade 1-2 comprising constitutional symptoms, GI toxicity, rash and myelosuppression. There were limited grade 3 or 4 toxicities, involving syncope, pneumonia, hypertension, atrial fibrillation, neutropenia and thrombocytopenia.
  • ||||||||||  RG6123 / Roche
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases:  A Study of RO7172508 in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors (clinicaltrials.gov) -  Aug 8, 2019   
    P1,  N=26, Terminated, 
    Explorations of sequential administration and selective BTK-inhibitors may reveal the optimal combination of novel agents in MCL. N=150 --> 26 | Trial completion date: Dec 2020 --> Jul 2019 | Recruiting --> Terminated | Trial primary completion date: Dec 2020 --> Jul 2019; Study terminated due to change in benefit-risk ratio, driven by high incidence GI toxicity in absence of clinically significant anti-tumor efficacy.
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Zydelig (idelalisib) / Gilead
    Trial completion date, Trial primary completion date:  Sequential Regimen of Bendamustine-Debulking Followed by CAL-101 and GA101-Induction and -Maintenance in CLL (CLL2-BCG) (clinicaltrials.gov) -  Jul 30, 2019   
    P2,  N=62, Recruiting, 
    N=150 --> 26 | Trial completion date: Dec 2020 --> Jul 2019 | Recruiting --> Terminated | Trial primary completion date: Dec 2020 --> Jul 2019; Study terminated due to change in benefit-risk ratio, driven by high incidence GI toxicity in absence of clinically significant anti-tumor efficacy. Trial completion date: May 2020 --> Jun 2024 | Trial primary completion date: May 2019 --> Oct 2021
  • ||||||||||  Review, Journal, Residual disease:  Minimal residual disease in chronic lymphocytic leukaemia. (Pubmed Central) -  Jul 28, 2019   
    A therapeutic approach guided by the level of MRD might also determine which patients would benefit from an early stop or consolidation therapy. In this review, we discuss the different MRD methods of analysis, which source of tumour samples must be analysed, the future role of the detection of circulating tumour DNA, and the potential role of MRD negativity in clinical practice in the modern era of CLL therapy.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, ibrutinib / Generic mfg.
    P1 data, Journal:  Phase 1b study of obinutuzumab, ibrutinib, and venetoclax in relapsed and refractory chronic lymphocytic leukemia. (Pubmed Central) -  Jul 24, 2019   
    P1/2
    We found this regimen to be safe and tolerable in CLL and capable of inducing deep responses justifying future study in our ongoing phase 2 cohorts of relapsed or refractory and treatment-naïve patients as well as larger phase 3 trials currently in planning. The study is registered to https://clinicaltrials.gov as NCT02427451.
  • ||||||||||  Rituxan (rituximab) / Roche, Biogen
    Clinical, Journal:  Outcome of patients aged 80 years or older treated for chronic lymphocytic leukaemia. (Pubmed Central) -  Jul 17, 2019   
    The remaining patients received CLB (n = 19) or fludarabine (F, n = 10), F/cyclophosphamide (FC, n = 1), FC/rituximab (FCR, n = 2) or bendamustine/rituximab (BR, n = 3)...These findings suggest that anti-leukaemic treatment including chemoimmunotherapy is feasible and efficacious in ≥80-year-old CLL patients. However, this group of patients lives for a shorter time than age-matched controls of the general population.
  • ||||||||||  Rituxan (rituximab) / Roche, Biogen
    Clinical, Review, Journal, Residual disease, IO Biomarker:  The Minimal Residual Disease in Non-Hodgkin's Lymphomas: From the Laboratory to the Clinical Practice. (Pubmed Central) -  Jul 12, 2019   
    Finally, NGS technologies could be more useful than the classical "patient allele-specific PCR" because they can identify any possible clone emerging during the treatment or follow-up, even if different from that identified at diagnosis, thus predicting relapse. After all, the present available molecular approaches can move MRD from the bench side to the clinical practice.
  • ||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Journal:  Evaluation of Next-Generation Anti-CD20 Antibodies Labeled with Zirconium 89 in Human Lymphoma Xenografts. (Pubmed Central) -  Jul 11, 2019   
    Tositumomab had much higher splenic uptake (186.4 ± 49.7, P < .001) than the other antibodies. 89Zr-labeled obinituzumab and ofatumumab localized to tumor as well as or better than labeled rituximab and tositumomab, two mAbs that have been used previously in B-cell lymphoma radioimmunotherapy, and both obinutuzumab and ofatumumab have the potential for repeated dosing.
  • ||||||||||  Trial primary completion date, Combination therapy:  Phase 1b Safety and Efficacy Study of TRU-016 (clinicaltrials.gov) -  Jul 5, 2019   
    P1b,  N=123, Active, not recruiting, 
    Therefore, shaving may represent an important mechanism of resistance when modulation is curtailed, and glycoengineering mAb to increase affinity for FcγR may enhance resistance because of shaving. Trial primary completion date: Jun 2019 --> Oct 2019