- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Obinutuzumab Rescue in Rituximab Resistant Mixed Cryoglobulinemia. (Pubmed Central) - Mar 19, 2021
CCP should be transfused as early as possible in patients with COVID-19 and humoral immunodeficiency. No abstract available
- |||||||||| Cotellic (cobimetinib) / Exelixis, Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Zelboraf (vemurafenib) / Roche
New P2 trial: STEP-WISE COMBINATION OF OBINUTUZUMAB, VEMURAFENIB AND COBIMETINIB IN PATIENTS WITH HAIRY CELL LEUKEMIA (HCL) PREVIOUSLY TREATED WITH PURINE ANALOGS OR UNFIT FOR CHEMOTHERAPY: A PHASE-2, SINGLE-ARMS, ITALIAN, MULTICENTER STUDY (HCL-PG04) COMBINAZIONE SEQUENZIALE DI OBINUTUZUMAB, VEMURAFENIB E COBIMETINIB IN PAZIENTI CON LEUCEMIA A CELLULE CAPELLUTE (HAIRY CELL LEUKEMIA (EUDRACT) - Mar 18, 2021
P2, N=42, Ongoing,
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] TREATMENT OF COVID-19 IN 22 B-CELL–DEPLETED PATIENTS () - Mar 18, 2021 - Abstract #CROI2021CROI_600;
Our observation shows that for carefully selected patients, antibody-based therapy can be effective. After transfusion of 600mL of ConvP, all patients had seroconverted to high anti-RBD antibody titers and detectable PRNT50 titers of 1:20 or higher.
- |||||||||| Clinical, Review, Journal, IO biomarker: Managing chronic lymphocytic leukemia in 2020: an update on recent clinical advances with a focus on BTK and BCL-2 inhibitors. (Pubmed Central) - Mar 16, 2021
Robust results have also been reported for ibrutinib plus venetoclax, and "triple" combinations of a BTK inhibitor, venetoclax, and obinutuzumab are now being pursued. The major questions facing the field at present are how best to select patients for BTK inhibitor monotherapy versus venetoclax/obinutuzumab upfront, what to do after failure of both BTK inhibitor(s) and venetoclax, and the ideal way to integrate measurable residual disease data into decisions regarding treatment choice, duration, and discontinuation.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Jakafi oral (ruxolitinib) / Novartis, Incyte, Gazyva (obinutuzumab) / Roche, Biogen
[VIRTUAL] The One-Two Punch: SARS-CoV-2 and Acute Fibrinous and Organizing Pneumonia () - Mar 14, 2021 - Abstract #ATS2021ATS_3956;
Case description:A 49-year-old male with a history of Diabetes Mellitus and Chronic Lymphocytic Lymphoma on Venetoclax and Obinutuzumab presented with fever, exertional dyspnea, and dry cough and was diagnosed with COVID-19...However, he required high flow supplemental oxygen and was unable to be weaned past 100% fraction of inspired oxygen; as a result, Ruxolitinib was added...Notably, 30% - 60% of intensive care patients with SARS CoV 1 had OP and AFOP. Additionally, the CT findings of COVID-19 are similar to OP and this lends support to the possibility that OP is an underlying pattern of lung injury in COVID-19.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen
[VIRTUAL] Prolonged Novel Coronavirus 2019 Infection with Negative Immunoglobulins in a Patient on Obinutuzumab () - Mar 14, 2021 - Abstract #ATS2021ATS_2120;
However he had persistent clinical deterioration, elevated inflammatory markers, as well as worsening serial CT images suggesting a prolonged active infection. The findings in our patient may have significant implications in the isolation, management and prognosis of patients receiving immunosuppressive therapy, specifically anti CD 20 management.
- |||||||||| Revlimid (lenalidomide) / BMS
[VIRTUAL] Video Consensus or Controversy? Clinical Investigator Perspectives on the Current and Future Management of Chronic Lymphocytic Leukemia and Follicular Lymphoma () - Mar 12, 2021 - Abstract #ASCO2021ASCO_158;
Recognize the recent FDA approval of tazemetostat for R/R FL, and identify patients for whom treatment with this novel agent may be appropriate...American Board of Internal Medicine (ABIM) — Maintenance of Certification (MOC) Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1 Medical Knowledge MOC point in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen
P2 data, Journal: Phase II Study of Combination Obinutuzumab, Ibrutinib, and Venetoclax in Treatment-Naïve and Relapsed or Refractory Chronic Lymphocytic Leukemia. (Pubmed Central) - Mar 10, 2021
As the presence of high-risk genomic features can predict response to CLL treatment, nurse-patient education on the importance of testing for these features and their implications on treatment selection is crucial. The combination regimen of obinutuzumab, ibrutinib, and venetoclax offers time-limited treatment that results in deep remissions and is now being studied in phase III cooperative group trials.
- |||||||||| ST-067 / Simcha Therap, Keytruda (pembrolizumab) / Merck (MSD), Gazyva (obinutuzumab) / Roche, Biogen
New P1 trial, Combination therapy, Monotherapy, Metastases: KEYNOTE-E64: Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067 (clinicaltrials.gov) - Mar 7, 2021
P1a, N=198, Not yet recruiting,
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Calquence (acalabrutinib) / AstraZeneca
[VIRTUAL] Fanconi Syndrome Secondary to Non-crystalline Light Chain Proximal Tubulopathy in Chronic Lymphocytic Leukemia: a rare presentation of a common disease () - Mar 2, 2021 - Abstract #NKFSCM2021NKF-SCM_583;
He was treated with ibrutinib, idelasilib and acalabrutinib with various side effects leading to discontinuation...Bone marrow biopsy revealed 70% involvement of CLL without plasma cell disorder. Due to the progression of CLL, the patient was started on Obinutuzumab and Venetoclax...CONCLUSION LCPT is an extremely rare presentation of CLL. Pronase-digested paraffin IF should be performed in cases with high suspicion due to false negative frozen IF especially in non-crystalline LCPT.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Enrollment open: Obinutuzumab, Ibrutinib, and Venetoclax for the Treatment of Previously Untreated Stage II-IV Follicular Lymphoma (clinicaltrials.gov) - Mar 1, 2021
P2, N=40, Recruiting,
Trial completion date: Dec 2020 --> Apr 2021 Not yet recruiting --> Recruiting
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Tecentriq (atezolizumab) / Roche
Trial 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) - Feb 26, 2021
P2, N=65, Recruiting,
Not yet recruiting --> Recruiting Trial completion date: Jan 2022 --> Feb 2021
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment open, 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) - Feb 23, 2021
P1, N=60, Recruiting,
Active, not recruiting --> Completed Suspended --> Recruiting | Trial completion date: Jan 2021 --> Jan 2022 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| Calquence (acalabrutinib) / AstraZeneca
Clinical, Review, Journal: The role of acalabrutinib in adults with chronic lymphocytic leukemia. (Pubmed Central) - Feb 23, 2021
Ibrutinib was the first-in-class drug which was initially approved by the US Food and Drug Administration (FDA) for the treatment of patients with relapsed/refractory and later for patients with treatment-naïve CLL...The ELEVATE TN trial investigated acalabrutinib with or without obintuzumab versus chlorambucil-obinutuzumab in older and frail patients with previously untreated CLL...Both trials demonstrated superiority of the acalabrutinib-containing arms in terms of both efficacy and tolerability. Unfortunately, the availability of new generation BTK inhibitors has not resulted in mitigating the financial toxicities associated with these potentially life-long treatments.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Rituximab and obinutuzumab differentially hijack the B cell receptor and NOTCH1 signaling pathways. (Pubmed Central) - Feb 23, 2021
As a consequence, rituximab appears to reinforce BCL2-mediated apoptosis resistance. The unexpected complexity and differences by which rituximab and obinutuzumab interfere with signaling pathways essential for lymphoma pathogenesis and treatment provide important impetus to optimize and personalize the application of different anti-CD20 treatments.
- |||||||||| Quzyttir (cetirizine injection) / TerSera Therap
Trial completion: TER-QZTR-001: Phase 2 Study IV QUZYTTIR (clinicaltrials.gov) - Feb 23, 2021
P2, N=34, Completed,
The unexpected complexity and differences by which rituximab and obinutuzumab interfere with signaling pathways essential for lymphoma pathogenesis and treatment provide important impetus to optimize and personalize the application of different anti-CD20 treatments. Active, not recruiting --> Completed
- |||||||||| Columvi (glofitamab-gxbm) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Phase classification, Trial completion date, Trial primary completion date, Combination therapy: NP30179: A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov) - Feb 21, 2021
P1/2, N=860, Recruiting,
Active, not recruiting --> Completed Phase classification: P1 --> P1/2 | Trial completion date: Jun 2022 --> Jun 2023 | Trial primary completion date: Jun 2022 --> Jun 2023
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date, Trial primary completion date: Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) (clinicaltrials.gov) - Feb 16, 2021
P2, N=77, Recruiting,
Leukemias are well known to cause cardiac infiltration, however this has not been previously seen with CLL. Trial completion date: Feb 2021 --> Feb 2022 | Trial primary completion date: Feb 2021 --> Feb 2022
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Enrollment open, Monotherapy: CLL17: Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL) (clinicaltrials.gov) - Feb 14, 2021
P3, N=897, Recruiting,
N=116 --> 284 Not yet recruiting --> Recruiting
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Zelboraf (vemurafenib) / Roche
Trial completion date, Trial primary completion date: A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia (clinicaltrials.gov) - Feb 4, 2021
P2, N=30, Recruiting,
Not yet recruiting --> Recruiting Trial completion date: Jan 2021 --> Jan 2022 | Trial primary completion date: Jan 2021 --> Jan 2022
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen
Clinical, Journal: Acute thrombocytopenia after obinutuzumab administration in a patient with relapsed follicular lymphoma (Pubmed Central) - Feb 3, 2021
Although OBZ administration-associated thrombocytopenia is a relatively common complication, acute thrombocytopenia up to 24 hours after administration is rare. However, as in this case, thrombocytopenia may progress in an extremely short time after administration, and it is necessary for clinicians to pay attention to OBZ treatment.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Trial initiation date, Monotherapy: CLL17: Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL) (clinicaltrials.gov) - Feb 3, 2021
P3, N=897, Not yet recruiting,
However, as in this case, thrombocytopenia may progress in an extremely short time after administration, and it is necessary for clinicians to pay attention to OBZ treatment. Initiation date: Dec 2020 --> Mar 2021
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