- |||||||||| FT516 / Fate Therap
Enrollment closed, Enrollment change, Combination therapy, Monotherapy, Metastases: FT516-101: FT516 in Subjects With Advanced Hematologic Malignancies (clinicaltrials.gov) - May 3, 2023
P1, N=72, Active, not recruiting,
Recruiting --> Active, not recruiting | N=552 --> 98 Recruiting --> Active, not recruiting | N=234 --> 72
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Tecentriq (atezolizumab) / Roche
Results of MOLTO, a multicenter, open label, phase II clinical trial evaluating venetoclax, atezolizumab and obinutuzumab combination in Richter syndrome. (Live Stream | S100a) - Apr 26, 2023 - Abstract #ASCO2023ASCO_4017;
P2
This regimen led to durable remissions, longer than 2 yrs in one third of responders. Clinical trial information: NCT04082897.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Comparative analysis of rituximab or obinutuzumab combined with CHOP in first-line treatment of follicular lymphoma. (Pubmed Central) - Apr 14, 2023
The median OS was 3.3 years (95% CI 2.6 Similar results were found in the GALLIUM subgroup analysis study, suggesting that at this time there is no absolute benefit to administer G-CHOP instead of R-CHOP in all patients with previously untreated FL and may encourage clinical and economic trials including quality of life data.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Onureg (azacitidine oral) / BMS, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment closed, Enrollment change: A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma (clinicaltrials.gov) - Apr 13, 2023
P1/2, N=2, Active, not recruiting,
Similar results were found in the GALLIUM subgroup analysis study, suggesting that at this time there is no absolute benefit to administer G-CHOP instead of R-CHOP in all patients with previously untreated FL and may encourage clinical and economic trials including quality of life data. Recruiting --> Active, not recruiting | N=50 --> 2
- |||||||||| Onureg (azacitidine oral) / BMS, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date, Trial primary completion date: CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma (clinicaltrials.gov) - Apr 10, 2023
P1, N=24, Recruiting,
This sensitive bioassay appears suitable for assess serum samples for antiviral antibodies that will support ADCC. Trial completion date: Apr 2023 --> Apr 2024 | Trial primary completion date: Oct 2022 --> Oct 2023
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Trial primary completion date: Ibrutinib, Fludarabine Phosphate, Cyclophosphamide, and Obinutuzumab in Treating Patients With Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Apr 6, 2023
P2, N=81, Active, not recruiting,
Trial completion date: Apr 2023 --> Apr 2024 | Trial primary completion date: Oct 2022 --> Oct 2023 Trial completion date: Mar 2023 --> Mar 2024 | Trial primary completion date: Mar 2023 --> Mar 2024
- |||||||||| Calquence (acalabrutinib) / AstraZeneca
Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost-effectiveness of acalabrutinib regimens in treatment-na (Pubmed Central) - Mar 30, 2023
Probabilistic sensitivity analysis showed the probability of acalabrutinib monotherapy being cost effective as 59% to 73% at a $100,000-to-150,000/QALY willingness-to-pay threshold; the probability of acalabrutinib + obinutuzumab being cost effective ranged from 34% to 51%. Although the analysis is limited by uncertainty in postprogression survival outcomes, acalabrutinib monotherapy is likely cost effective vs chlorambucil + obinutuzumab in treatment-na
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Trial completion date, Trial primary completion date, Combination therapy, Minimal residual disease: A Study on Limiting Treatment Time With Acalabrutinib Combined With Obinutuzumab in People With CLL or SLL (clinicaltrials.gov) - Mar 28, 2023
P2, N=55, Active, not recruiting,
Although the analysis is limited by uncertainty in postprogression survival outcomes, acalabrutinib monotherapy is likely cost effective vs chlorambucil + obinutuzumab in treatment-na Trial completion date: Feb 2023 --> Feb 2024 | Trial primary completion date: Feb 2023 --> Feb 2024
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion, Trial completion date, Combination therapy: PrE0403: Phase II Venetoclax, Obinutuzumab and Bendamustine in High Tumor Burden Follicular Lymphoma as Front Line Therapy (clinicaltrials.gov) - Mar 28, 2023
P2, N=56, Completed,
Trial completion date: Feb 2023 --> Feb 2024 | Trial primary completion date: Feb 2023 --> Feb 2024 Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Jan 2023
- |||||||||| Review, Journal: Diagnosis and Treatment of Chronic Lymphocytic Leukemia: A Review. (Pubmed Central) - Mar 25, 2023
In patients with multiple relapses, chimeric antigen receptor T-cell (CAR-T) therapy with lisocabtagene maraleucel was associated with a 45% complete response rate...Approximately two-thirds of patients eventually need treatment. Highly effective novel targeted agents include BTK inhibitors such as acalabrutinib, zanubrutinib, ibrutinib, and pirtobrutinib or BCL2 inhibitors such as venetoclax.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Acute Neuromuscular Respiratory Failure Secondary to West Nile Infection in a Patient With CLL (Walter E. Washington Convention Center, Area A, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_7982;
IVIG, steroids and plasmapheresis have been described in case reports with limited benefit and further research is warranted. Clinicians should maintain a high index of suspicion for WNV illness while evaluating patients with fever, weakness, and other neurological manifestations during summer months, in endemic regions.
- |||||||||| Lagevrio (molnupiravir) / Ridgeback Biotherap, Merck (MSD)
Diverse Gene Mutations by Molnupiravir After B-Cell Depletion Therapy: Report of 2 COVID-19 Cases (Walter E. Washington Convention Center, Area A, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_6999;
Three days after the onset, he was treated with molnupiravir, which resolved the fever; 47 days later, he was hospitalized for COVID-19 pneumonia (Rt-PCR positive) and was treated with steroids, antiviral drugs (nirmatrelvir/ritonavir, remdesivir), and monoclonal antibodies therapy...Case 2 was a 74-year-old man with diffuse large B cell lymphoma who had last been treated with rituximab 7 months before COVID-19...In particular, mutations in the RBD region of the spike protein affect therapeutic efficacy. In immunosuppressed patients with prolonged infection, mornupiravir may cause severe mutations for the next variants of SARS-CoV-2.
- |||||||||| Successful Use of Monoclonal and Antiviral Therapy in Immunocompromised Patients With Persistent and/or Relapsing COVID-19 (Walter E. Washington Convention Center, Area A, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_6997;
Nirmatrelvir-ritonavir (NM/r) is an oral antiviral, which has proven to reduce by 89% the risk of progression to severe COVID-19 among high-risk patients with early-stage, symptomatic COVID-19...MethodsWe describe five cases of persistent and/or relapsing COVID-19 in immunocompromised patients observed at the Careggi University Hospital, Florence, Italy successfully treated with oral NM/r or mAbs infusion.ResultsPatient 1 (62-years-old, male, non-Hodgkin lymphoma -NHL- on obinutuzumab) recovered from mild SARS-CoV-2 infection, treated with sotrovimab...NM/r was administered.Patient 3 (59-years-old, male, polyangiite on rituximab, micofenolate, steroids) experienced severe COVID-19 requiring non-invasive ventilation, treated with remdesivir and tocilizumab...All patients showed a rapid and full clinical, virological and radiologic response to NM/r or mAbs treatment.ConclusionsIn our cases, COVID-19 relapse occurred despite initial treatment with remdesivir and/or sotrovimab. At the time of writing, 4-5 months after NM/r or mABs administration, we have no evidence of further COVID-19 relapse in these patients.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Paxlovid (nirmatrelvir and ritonavir) / Pfizer, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
COVID: The Cranberry of Viral Illnesses (Walter E. Washington Convention Center, Area A, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_6992;
In February 2022 he suffered from a COVID infection, treated with nirmatrelvir/ritonavir...He continues on a prednisone taper with Bactrim for PJP prophylaxis...However, these studies may underestimate the true incidence of post COVID pneumonia, as they do not take into account patients who do not require hospitalization. Our study adds to the body of evidence supporting the existence of post-COVID organizing pneumonia and suggests that patients are at risk for this disease process, regardless of hospitalization.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Calquence (acalabrutinib) / AstraZeneca
Trial primary completion date: Avo In R/R And Previously Untreated MCL (clinicaltrials.gov) - Mar 16, 2023
P1/2, N=53, Recruiting,
Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> May 2022 Trial primary completion date: Jan 2024 --> Dec 2024
- |||||||||| MS-553 / MingSight Pharma
Trial completion date, Trial primary completion date: A Study Of The Selective PKC-? Inhibitor MS- 553 (clinicaltrials.gov) - Mar 15, 2023
P1/2, N=117, Recruiting,
Recruiting --> Suspended Trial completion date: Feb 2023 --> Jun 2024 | Trial primary completion date: Feb 2023 --> Apr 2024
- |||||||||| Ocrevus (ocrelizumab) / Roche, Biogen, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Development of a novel, highly sensitive assay for quantification of minimal residual B cells in autoimmune disease and comparison to traditional methods across B-cell depleting agents. (Pubmed Central) - Mar 14, 2023
After 4?weeks, 10% of patients treated with rituximab retained detectable B cells vs 1.8% with ocrelizumab and 1.7% for obinutuzumab; at 24?weeks 93% of patients who received obinutuzumab remained below LLOQ vs 63% for rituximab. More-sensitive measurements of B cells may reveal differences in potency among anti-CD20 agents, which may associate with clinical outcomes.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Trial completion date, Trial primary completion date, Combination therapy: Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Mar 14, 2023
P2, N=60, Recruiting,
Based on the favorable safety profile and prolonged responses, including CRs, in patients where response from a single agent CPI may not be expected, further evaluation of this combination is warranted including patients who have received prior CPI therapy. Trial completion date: Feb 2023 --> Jun 2024 | Trial primary completion date: Feb 2023 --> Jun 2024
- |||||||||| 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) - Mar 14, 2023
P2, N=65, Recruiting,
Trial completion date: Feb 2023 --> Jun 2024 | Trial primary completion date: Feb 2023 --> Jun 2024 Trial completion date: Feb 2023 --> Feb 2025 | Trial primary completion date: Feb 2023 --> Feb 2025
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Roche
Enrollment closed: CRISTALLO: A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation (clinicaltrials.gov) - Mar 9, 2023
P3, N=165, Active, not recruiting,
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
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