- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy: Atezolizumab, Obinutuzumab, and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Relapsed or Refractory Richter Syndrome (clinicaltrials.gov) - Oct 6, 2021 P2, N=65, Recruiting, No abstract available Trial completion date: Feb 2021 --> Feb 2023 | Trial primary completion date: Feb 2021 --> Feb 2023
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial primary completion date: CLL2-GiVe: Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Patients With CLL (clinicaltrials.gov) - Oct 5, 2021 P2, N=40, Active, not recruiting, Trial completion date: Feb 2021 --> Feb 2023 | Trial primary completion date: Feb 2021 --> Feb 2023 Trial primary completion date: Dec 2020 --> Jan 2022
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen
Clinical, P3 data, Journal, HEOR: Health-related quality of life with fixed-duration venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: Results from the randomized, phase 3 CLL14 trial. (Pubmed Central) - Oct 1, 2021 According to MDASI scores, CLL symptoms (1.5 [±1.2] and 1.6 [±1.3]), core cancer symptoms (1.5 [±1.4] and 1.8 [±1.7]) and symptom interference (2.1 [±2.3] and 2.3 [±2.3]) were generally low and comparable between treatment arms at baseline and were maintained throughout treatment and follow-up. This analysis demonstrates that the higher efficacy of Ven-Obi is not associated with QoL impairment and that Ven-Obi achieves early relief of CLL-related symptoms in elderly unfit patients.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal: Skipping a step or "impatientitis": what happened to the design of randomized clinical trials in chronic lymphocytic leukaemia? (Pubmed Central) - Sep 30, 2021 Similarly, two large trials omitted venetoclax monotherapy and proceeded directly to venetoclax + rituximab or obinutuzumab versus chemoimmunotherapy...Thus, we are left with regimens which are undoubtedly effective, but might actually be unnecessarily toxic and expensive. The solution to this problem is simple: future randomized trials should be carefully designed in a 'step by step' fashion which would provide the CLL community with simple yet robust answers regarding efficacy of novel regimens so that these can be introduced to practice following the best principles of evidence-based medicine.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal: From pathogenesis to personalized treatments of neuropathies in hematological malignancies. (Pubmed Central) - Sep 29, 2021 Recently, high-throughput technologies, and next-generation sequencing have increased our knowledge of hematological diseases pathogenesis by the identification of somatic mutation affecting pivotal signalling pathways. Accordingly, new target therapies are used that may also be borrowed for treatment of neuropathies in hematological diseases.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Zelboraf (vemurafenib) / Roche
Enrollment closed: A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia (clinicaltrials.gov) - Sep 27, 2021 P2, N=30, Active, not recruiting, Accordingly, new target therapies are used that may also be borrowed for treatment of neuropathies in hematological diseases. Recruiting --> Active, not recruiting
- |||||||||| Columvi (glofitamab-gxbm) / Roche, englumafusp alfa (RG6076) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Phase classification, Enrollment change, Combination therapy: A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of RO7227166 in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab Administered in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov) - Sep 24, 2021 P1/2, N=362, Recruiting, Biomarker analyses supported efficacy in the specific subgroups. Phase classification: P1 --> P1/2 | N=207 --> 362
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment change, Trial suspension: VENOBI-CNS: Venetoclax and Obinutuzumab for Relapsed/Refractory Primary CNS Lymphoma (clinicaltrials.gov) - Sep 22, 2021 P1, N=4, Suspended, No abstract available N=15 --> 4 | Recruiting --> Suspended
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Roche
New P2 trial: ORION: Obinutuzumab in Primary MN (clinicaltrials.gov) - Sep 19, 2021 P2, N=20, Not yet recruiting,
- |||||||||| Arzerra (ofatumumab) / Novartis, Genmab
Journal: Monoclonal Antibodies, Bispecific Antibodies and Antibody-Drug Conjugate in Oncohematology. (Pubmed Central) - Sep 19, 2021 Trial completion date: Aug 2021 --> Nov 2024 | Trial primary completion date: Aug 2021 --> Nov 2024 Immunotherapy and immuno-chemotherapy have improved the outcome of the patients with malignant hemopathies through a targeted, personalized therapy, with reduced systemic toxicity, which in some cases can even induce deep complete remissions, including minimal residual disease negativity.
- |||||||||| rhIL-15 / National Cancer Institute
Enrollment change, Trial suspension: Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocyte Leukemia (clinicaltrials.gov) - Sep 16, 2021 P1, N=1, Suspended, Immunotherapy and immuno-chemotherapy have improved the outcome of the patients with malignant hemopathies through a targeted, personalized therapy, with reduced systemic toxicity, which in some cases can even induce deep complete remissions, including minimal residual disease negativity. N=24 --> 1 | Recruiting --> Suspended
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal: The current therapeutic landscape for follicular lymphoma (Pubmed Central) - Sep 10, 2021 For advanced-stage low tumor burden patients, watchful waiting remains the standard treatment, whereas rituximab monotherapy may be an alternative option...Recently, the novel anti-CD20 monoclonal antibody obinutuzumab was approved for the treatment of FL...During the last decade, the development of biological knowledge and use of molecularly targeted agents offer new therapeutic perspectives with chemo-free strategies. This review highlights the current standards for the treatment of FL.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
Enrollment open, Trial initiation date, Monotherapy: SAVE: Safe Accelerated Venetoclax Escalation in CLL (clinicaltrials.gov) - Sep 9, 2021 P1, N=40, Recruiting, This review highlights the current standards for the treatment of FL. Not yet recruiting --> Recruiting | Initiation date: Aug 2021 --> Apr 2021
- |||||||||| Revlimid (lenalidomide) / BMS
Looking past a Positive Clostridioides difficile Test (Shoreline Exhibit Hall) - Sep 8, 2021 - Abstract #ACG2021ACG_767; Stool PCR for C. difficile had been positive two months prior and diarrhea persisted despite multiple courses of vancomycin and fidaxomicin...She was discharged home on valganciclovir and seen in clinic six weeks later with complete resolution of her diarrhea...Other causes of colitis should be considered when symptoms persist despite anti-CDI therapies, especially in immunocompromised patients. We present two cases of CMV colitis masquerading as CDI.Figure: Colonic ulceration secondary to CMV colitis
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen
Chronic Lymphoid Leukemia With Extensive Liver Infiltration in the Absence of Leukemic Transformation (Shoreline Exhibit Hall) - Sep 8, 2021 - Abstract #ACG2021ACG_244; Patient reported taking glimepiride, atorvastatin and herbal supplements (GNC50+ multivitamin, fertility and prostate multivitamin) that were stopped five months prior to encounter due to concerns of drug-induced liver injury (DILI)...Patient was initiated on Venetoclax and Obinutuzumab as an outpatient...Due to severe pattern of liver infiltration, worsening LE, portal hypertension, and hepatosplenomegaly it was ultimately decided to start patient on chemotherapy.Figure: Image A:CT abdomen and pelvis with IV contrast depicting an enlarged 33.4x42.9mm periportal lymph nodeImage B: CT abdomen and pelvis with IV contrast depicting 11.7x18.3mm pancreatic lymph nodeImage C: : H&E; (400x) section demonstrates an atypical lymphoid follicle surrounding bile ductules, with adjacent liver parenchyma. Characteristic immunohistochemical staining of the neoplastic cells shows positivity for CD20 (dim), CD5, CD23, and is negative for CD3Image D: ZAP 70 (400x) staining (brown) of neoplastic cells has been associated with a poor prognosis
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen
Journal: An update of venetoclax and obinutuzumab in chronic lymphocytic leukemia. (Pubmed Central) - Sep 8, 2021 Venetoclax, an oral anti-apoptotic BCL-2 inhibitor, in combination with a CD20 antibody has shown superiority to chemoimmunotherapy in treatment-naive and relapsed/refractory CLL. Obinutuzumab is a novel anti-CD20 monoclonal antibody that has been safely combined with novel agents including venetoclax and Bruton tyrosine kinase inhibitors and has shown superiority over rituximab when combined with chlorambucil.
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