- |||||||||| Venclexta (venetoclax) / Roche, AbbVie
Review, Journal: Practical Management of the Venetoclax-Treated Patient in Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia. (Pubmed Central) - Jun 28, 2022
Venetoclax, in combination with azacitidine, decitabine, or low-dose cytarabine, is also approved in the United States for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are ≥ 75 years or have comorbidities that preclude use of intensive induction chemotherapy...It is therefore essential to provide information on the appropriate management of venetoclax-associated side effects. This article discusses the efficacy and safety of venetoclax administration and presents strategies specifically for the management of neutropenia and certain nonhematologic adverse events in patients receiving venetoclax for the treatment of AML and CLL.
- |||||||||| FT596 / Fate Therap
Enrollment change, Combination therapy, Monotherapy: FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies (clinicaltrials.gov) - Jun 27, 2022
P1, N=552, Recruiting,
This article discusses the efficacy and safety of venetoclax administration and presents strategies specifically for the management of neutropenia and certain nonhematologic adverse events in patients receiving venetoclax for the treatment of AML and CLL. N=285 --> 552
- |||||||||| Review, Journal, IO biomarker: SOHO State of the Art Updates and Next Questions | Management of Most Difficult Cases of Chronic Lymphocytic Leukemia: Relapse After Both BTK and BCL2 Inhibition and Richter Transformation. (Pubmed Central) - Jun 22, 2022
In the second case, a patient with CLL and del 17p develops a Richter transformation to diffuse large B-cell lymphoma after treatment with obinutuzumab, chlorambucil, ibrutinib, venetoclax, and idelalisib...The literature pertaining to these two scenarios is reviewed, including the role of available targeted therapies, chemoimmunotherapy, and hematopoietic cell transplantation. Emerging novel therapies, including reversible BTK inhibitors and CAR T cell therapy, are discussed.
- |||||||||| Journal: Epidermal necrolysis in the context of immuno-oncologic medication as well as kinase inhibitors and biologics. (Pubmed Central) - Jun 22, 2022
Fourteen cases were EN-like reactions: six bullous lichenoid drug eruptions (DE) to pembrolizumab (2), obinutuzumab, nivolumab, rituximab, infliximab/nivolumab, and eight multiforme-like DE to rituximab (2), adalimumab, ramucirumab, bevacizumab, vemurafenib, sorafenib (2)...A correct diagnosis is highly relevant in terms of prognosis and use of these drugs in malignoma treatment. Re-exposure is contraindicated in EN, but possible in other DE after rigorous risk-benefit evaluation.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Trial suspension: A041702: Testing The Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Jun 16, 2022
P3, N=454, Suspended,
Re-exposure is contraindicated in EN, but possible in other DE after rigorous risk-benefit evaluation. Recruiting --> Suspended
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal, Heterogeneity: Clonal heterogeneity of polymorphic B-cell lymphoproliferative disease, EBV-positive, iatrogenic/immune senescence: implications on pathogenesis and treatment. (Pubmed Central) - Jun 14, 2022
Treatment with O-CHOP (obinutuzumab, cyclophosphamide, adriamycin, vincristine, prednisolone) led to undetectable plasma EBV DNA, suggesting eradiation of the EBV-positive malignant clone...On treatment with lenalidomide, she finally achieved complete metabolic response...However, the EBV- plasma cell lesion showed mutations in five genes (TP53, SF3B1, STAT5B, CD79B and CRKL), suggesting that these mutations instead of EBV infection were the oncogenic driver. The presence of both EBV+ and EBV- lesions, which showed different mutational profiles, indicated clonal heterogeneity that might be of biologic and therapeutic significance.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion, Combination therapy: SAKK 35/15: Obinutuzumab in Combination With Venetoclax in Previously Untreated Follicular Lymphoma Patients (clinicaltrials.gov) - Jun 10, 2022
P1, N=25, Completed,
The presence of both EBV+ and EBV- lesions, which showed different mutational profiles, indicated clonal heterogeneity that might be of biologic and therapeutic significance. Active, not recruiting --> Completed
- |||||||||| Columvi (glofitamab-gxbm) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche
Trial initiation date, Trial primary completion date, Combination therapy: CO43805: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - Jun 9, 2022
P1, N=112, Not yet recruiting,
Active, not recruiting --> Completed Initiation date: Apr 2022 --> Aug 2022 | Trial primary completion date: Dec 2024 --> Apr 2025
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Trial primary completion date: Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL (clinicaltrials.gov) - Jun 8, 2022
P2, N=72, Recruiting,
Initiation date: Apr 2022 --> Aug 2022 | Trial primary completion date: Dec 2024 --> Apr 2025 Trial primary completion date: Jul 2022 --> Jan 2024
- |||||||||| Journal: Immunotherapy in indolent Non-Hodgkin's Lymphoma. (Pubmed Central) - Jun 8, 2022
Other agents include MAB targeting T-Cells like mogamulizumab, Denileukin Diftitox and BiTEs or bispecific T cell engagers like Mosunetuzumab, Glofitamab, and Epcoritamab...Another important aspect in immunotherapy is the half-lives of the medication which is an important factor that can influence the evaluation of the response. The MAB treatment showed important benefit in the treatment of iNHL and it continuously shows how rapidly it can develop to provide optimum care and benefit to patients with iNHL.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Imbruvica (ibrutinib) / AbbVie, J&J
Trial suspension: Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System (clinicaltrials.gov) - Jun 8, 2022
P1, N=12, Suspended,
The MAB treatment showed important benefit in the treatment of iNHL and it continuously shows how rapidly it can develop to provide optimum care and benefit to patients with iNHL. Recruiting --> Suspended
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment closed: Bendamustine, Obinutuzumab, and Venetoclax in Patients With Untreated Mantle Cell Lymphoma (clinicaltrials.gov) - Jun 1, 2022
P2, N=23, Active, not recruiting,
Registered at ClinicalTrials.gov (NCT01722487 and NCT02264574). Recruiting --> Active, not recruiting
- |||||||||| MS-553 / MingSight Pharma
Enrollment change: A Study Of The Selective PKC-? Inhibitor MS- 553 (clinicaltrials.gov) - May 31, 2022
P1/2, N=117, Recruiting,
Trial completion date: Jul 2022 --> Mar 2023 | Trial primary completion date: Apr 2022 --> Dec 2022 N=47 --> 117
- |||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Otsuka, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Review, Journal: Lupus Nephritis: Improving Treatment Options. (Pubmed Central) - May 31, 2022
In the present article, we summarize the existing lupus nephritis management recommendations, followed by a critical appraisal of the randomized trials of belimumab and voclosporin, as well as the available data on obinutuzumab and other novel compounds under development. We conclude that pending the identification of accurate clinical, histological, or translational predictors for guiding personalized decisions, it is of utmost importance that lupus nephritis patients are monitored closely with appropriate treatment adjustments aiming at a prompt, deep response to ensure long-term preservation of kidney function.
- |||||||||| iberdomide (CC-220) / BMS
Enrollment change, Trial primary completion date, Combination therapy: A Dose Finding and Safety Study of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Lymphomas (clinicaltrials.gov) - May 31, 2022
P1/2, N=232, Recruiting,
We conclude that pending the identification of accurate clinical, histological, or translational predictors for guiding personalized decisions, it is of utmost importance that lupus nephritis patients are monitored closely with appropriate treatment adjustments aiming at a prompt, deep response to ensure long-term preservation of kidney function. N=152 --> 232 | Trial primary completion date: Jan 2022 --> Aug 2023
- |||||||||| glofitamab (RG6026) / Roche
Journal, CAR T-Cell Therapy: Glofitamab Treatment in Relapsed or Refractory DLBCL after CAR T-Cell Therapy. (Pubmed Central) - May 30, 2022
Interestingly, we identified increased persistence of circulating CAR T-cells in peripheral blood in three of the five patients with measurable CAR T-cells. Our data suggest that glofitamab treatment is well tolerated and effective in patients with DLBCL relapsing after CAR T-cell therapy and can enhance residual CAR T-cell activity.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche, Tecentriq (atezolizumab) / Roche
P2 data, Journal, Combination therapy, PD(L)-1 Biomarker, IO biomarker: A phase-II study of atezolizumab in combination with obinutuzumab or rituximab for relapsed or refractory mantle cell or marginal zone lymphoma or Waldenström's macroglobulinemia. (Pubmed Central) - May 29, 2022
P2
One fatal TEAE (pneumonia) occurred in each of the MCL and MZL groups. Biomarker analysis highlighted the importance of characterizing the immune environment to optimize efficacy of immunotherapy regimens.Trial registration details: EudraCT: 2016-003579-22.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Roche
Trial completion date, Metastases: A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM) (clinicaltrials.gov) - May 23, 2022
P3, N=1401, Completed,
Therefore, in those with previous responsiveness to B-cell depletion, switching to humanised type-2 anti-CD20 therapy is a logical approach following loss off efficacy. Trial completion date: Nov 2021 --> Jul 2021
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Obinutuzumab in Kidney Transplantation: Effect on B-cell Counts and Crossmatch Tests (Hynes Halls C & D: Board No. B131) - May 20, 2022 - Abstract #ATC2022ATC_2481;
*Purpose: Resistance to the action of rituximab (RTX), has been documented in several diseases. OBZ effectively depletes B-cell counts in sensitized kidney transplant candidates and, unlike RTX, has no effect on CDC crossmatch results.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Trial initiation date: FORTplus: Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody (clinicaltrials.gov) - May 17, 2022
P3, N=100, Not yet recruiting,
OBZ effectively depletes B-cell counts in sensitized kidney transplant candidates and, unlike RTX, has no effect on CDC crossmatch results. Initiation date: Dec 2021 --> Jun 2022
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
New P2 trial: PR3-AAV Resilient Remission or PRRR (clinicaltrials.gov) - May 17, 2022
P2, N=30, Not yet recruiting,
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Retrospective data, Review, Journal: Case Report: Use of Obinutuzumab as an Alternative Monoclonal Anti-CD20 Antibody in a Patient With Refractory Immune Thrombocytopenia Complicated by Rituximab-Induced Serum Sickness and Anti-Rituximab Antibodies. (Pubmed Central) - May 14, 2022
Additionally, a review of 10 previously published cases of serum-sickness associated with the use of rituximab for idiopathic thrombocytopenic purpura (ITP) is summarized. This case highlights that recognition of more subtle or rare symptoms of rituximab-induced serum sickness is important to facilitate rapid intervention.
- |||||||||| B-CELL MALIGNANCIES TREATED WITH TARGETED DRUGS AND SARS-COV-2 INFECTION. A EUROPEAN HEMATOLOGY ASSOCIATION SURVEY (EPICOVIDEHA) (Hall Strauss 1-2) - May 13, 2022 - Abstract #EHA2022EHA_2722;
Aims The aim of this study is to describe and analyse the outcome of COVID-19 patients with underlying LPD treated with targeted drugs such as monoclonal antibodies (obinutuzumab, ofatumumab, brentuximab, nivolumab or pembrolizumab), BTK inhibitors (ibrutinib, acalabrutinib), PI3K inhibitors (idelalisib), BCL2 inhibitors (venetoclax) and IMIDs, (lenalidomide)...Most used targeted drugs were ITKs (51.1%), anti-CD20 other than rituximab (16%), BCL2 inhibitors (7.3%) and lenalidomide (7.9%)...- COVID-19 vaccination was a protective factor for mortality, even in this population with humoral immunity impairment. - The learning curve in the management of the infection throughout the pandemic and the development of COVID-19 treatments showed benefit in this particularly vulnerable population.
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