- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Biogen, Roche, Imbruvica (ibrutinib) / AbbVie, J&J
Clinical, P2 data, P3 data, Journal: Treatment-naive CLL: lessons from phase 2 and phase 3 clinical trials. (Pubmed Central) - Mar 2, 2020
Current frontline trials are focused on the optimal sequencing or combination of targeted therapies. In this review, we will discuss the management of previously untreated CLL with an emphasis on the clinical trials that have formed the standard of care, as well as those newer studies that are likely to form the next generation of therapy.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, entospletinib (GS-9973) / Kronos Bio
Enrollment closed, Enrollment change, Combination therapy: Entospletinib and Obinutuzumab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma (clinicaltrials.gov) - Mar 2, 2020
P1/2, N=32, Active, not recruiting,
In this review, we will discuss the management of previously untreated CLL with an emphasis on the clinical trials that have formed the standard of care, as well as those newer studies that are likely to form the next generation of therapy. Recruiting --> Active, not recruiting | N=12 --> 32
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date, Trial primary completion date: O-ICE: Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL (clinicaltrials.gov) - Feb 27, 2020
P2, N=25, Recruiting,
Recruiting --> Active, not recruiting | N=12 --> 32 Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2019 --> Dec 2020
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Roche
New P3 trial: 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) - Feb 26, 2020
P3, N=165, Recruiting,
- |||||||||| Pixuvri (pixantrone) / Servier, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date, Combination therapy: GOAL: GA101 Plus Pixantrone for Relapsed Aggressive Lymphoma (clinicaltrials.gov) - Feb 23, 2020
P2, N=70, Active, not recruiting,
Trial completion date: Dec 2019 --> Jun 2020 Trial completion date: Oct 2021 --> Jun 2022
- |||||||||| Gazyva (obinutuzumab) / Biogen, Roche, Rituxan (rituximab) / Roche, Biogen
Clinical, P2 data, Journal, Combination therapy: Therapy of nodal Follicular Lymphoma (WHO grade 1/2) in clinical stage I/II using response adapted Involved Site Radiotherapy in combination with Obinutuzumab (Gazyvaro) - GAZAI Trial (GAZyvaro and response adapted Involved-site Radiotherapy): a study protocol for a single-arm, non-randomized, open, national, multi-center phase II trial. (Pubmed Central) - Feb 20, 2020
P2
However, these observations should be analyzed in future clinical trials. The goal of this trial is a further reduction of the radiation dose in patients with nodal early-stage FL showing a good response to a combination of LDRT and anti-CD20 immunotherapy and a comparison with the currently published MIR trial.
- |||||||||| Gazyva (obinutuzumab) / Biogen, Roche
Reducing Administration Errors when Titrating Obinutuzumab (Henry B. Gonzalez Convention Center - Tower View Registration) - Feb 17, 2020 - Abstract #ONS2020ONS_890;
There were zero reported titration errors with Obinutuzumab since implementation. The cards are an innovation for our institute and perhaps others, as little is published.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment open, Combination therapy: PrE0403: Phase II Venetoclax, Obinutuzumab and Bendamustine in High Tumor Burden Follicular Lymphoma as Front Line Therapy (clinicaltrials.gov) - Feb 10, 2020
P2, N=56, Recruiting,
The cards are an innovation for our institute and perhaps others, as little is published. Suspended --> 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 10, 2020
P2, N=28, Recruiting,
Suspended --> Recruiting Trial completion date: Jan 2020 --> Jan 2021 | Trial primary completion date: Jan 2020 --> Jan 2021
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen
Trial primary completion date: OLYMP-1: Obinutuzumab in Marginal Zone Lymphoma (clinicaltrials.gov) - Feb 6, 2020
P2, N=56, Recruiting,
Trial completion date: Jan 2020 --> Jan 2021 | Trial primary completion date: Jan 2020 --> Jan 2021 Trial primary completion date: Oct 2019 --> Oct 2020
- |||||||||| Soliris (eculizumab) / Alexion Pharma, efgartigimod IV (ARGX-113 IV) / argenx, Broteio, Rituxan (rituximab) / Roche, Biogen
Review, Journal: Immunotherapy in myasthenia gravis in the era of biologics. (Pubmed Central) - Jan 30, 2020
Belimumab, an antibody against the B cell trophic factor BAFF, was ineffective in phase III trials, and efgartigimod, which depletes antibodies, was effective in a phase II study...Checkpoint inhibitors can trigger MG in some patients, necessitating early intervention. Increased availability of new biologics provides targeted immunotherapies and the opportunities to develop more specific therapies.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, ibrutinib / Generic mfg.
Clinical, Review, Journal: Application of a sequential multiple assignment randomized trial (SMART) design in older patients with chronic lymphocytic leukemia. (Pubmed Central) - Jan 29, 2020
SMART design strategies can be used in cancer clinical trials with adaptive interventions to identify optimal treatment strategies. Further, standard software exists to provide sample size, power calculations, and data analysis for a SMART design.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Tecentriq (atezolizumab) / Roche
Trial completion: A Safety and Pharmacology Study of Atezolizumab (MPDL3280A) Administered With Obinutuzumab or Tazemetostat in Participants With Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - Jan 27, 2020
P1, N=96, Completed,
Further, standard software exists to provide sample size, power calculations, and data analysis for a SMART design. Active, not recruiting --> Completed
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Trial primary completion date, Combination therapy: A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Jan 15, 2020
P1, N=50, Active, not recruiting,
These results are encouraging, but further studies with wider cohorts are needed to confirm them. Trial completion date: Aug 2021 --> Jul 2023 | Trial primary completion date: Dec 2019 --> Jul 2020
- |||||||||| doxorubicin hydrochloride / Generic mfg., cyclophosphamide intravenous / Generic mfg., Rituxan (rituximab) / Roche, Biogen
Review, Journal: Front-line management of non-Hodgkin lymphoma in Australia. Part 1: follicular lymphoma. (Pubmed Central) - Jan 10, 2020
In the FL subgroup of the StiL trial, therapy with bendamustine plus rituximab significantly increased PFS compared with rituximab in combination with cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP), without rituximab maintenance. Initial tolerability may be more favourable with bendamustine than other therapies overall, but clinical vigilance is still required because of concerns of late infectious toxicities associated with prolonged T-cell depletion.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion, Trial completion date, Combination therapy: A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Jan 9, 2020
P1, N=82, Completed,
Initial tolerability may be more favourable with bendamustine than other therapies overall, but clinical vigilance is still required because of concerns of late infectious toxicities associated with prolonged T-cell depletion. Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Aug 2019
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Phase classification, Enrollment change: Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma (clinicaltrials.gov) - Jan 3, 2020
P1b/2, N=130, Recruiting,
Active, not recruiting --> Completed Phase classification: P1b --> P1b/2 | N=45 --> 130
- |||||||||| Clinical, Journal: Maintenance rituximab or observation after frontline treatment with bendamustine-rituximab for follicular lymphoma. (Pubmed Central) - Dec 29, 2019
Prospective trials have shown benefit of MR after R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) or R-CVP (rituximab, cyclophosphamide, vincristine, prednisone), yet recent data from the GALLIUM study comparing outcomes of patients treated with chemotherapy with R or obinutuzumab (G) showed higher than anticipated fatal adverse events with BR/BG...In the entire study population, the known fatal adverse event rate after BR was 2·5% and differed in those receiving MR versus no maintenance. Within the limitations inherent to retrospective analysis, these data suggest that FL patients with a PR to BR experience prolongation of remission with MR with an acceptable safety profile.
- |||||||||| P1 data, Journal: Venetoclax plus R- or G-CHOP in non-Hodgkin lymphoma: results from the CAVALLI phase 1b trial. (Pubmed Central) - Dec 20, 2019
P1/2
Here, we report a phase 1b study investigating dose escalation of the BCL2 inhibitor, venetoclax, in combination with rituximab or obinutuzumab and cyclophosphamide, doxorubicin, vincristine, and prednisone (R-/G-CHOP) chemotherapy in B-cell NHL...This regimen is subsequently being evaluated in first-line DLBCL in the phase 2 portion of the study. ClinicalTrials.gov identifier: NCT02055820.
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Review, Journal: Treating Older Patients with Chronic Lymphocytic Leukemia: A Personalized Approach. (Pubmed Central) - Dec 20, 2019
Treatment options include chemoimmunotherapy, monoclonal antibody-based approaches (such as the use of rituximab, ofatumumab, or obinutuzumab) and, more recently, small molecules (such as ibrutinib, idelalisib, and venetoclax). The choice of treatment is guided by the patient's performance status and co-morbidities and by the disease characteristics, such as chromosomal and molecular abnormalities, and in patients with recurrent disease also by the type of prior regimen, their tolerability, and duration of response.
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