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23 Diseases |  |
181 Trials |
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181 Trials |  |
4948 News |  |
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- Gazyva (obinutuzumab) / Biogen, Roche, Imbruvica (ibrutinib) / AbbVie, J&J, bendamustine / SymBio, Mundipharma, Astellas, Generic mfg.
Sequential Treatment with Bendamustine, Obinutuzumab (GA101) and Ibrutinib in Chronic Lymphocytic Leukemia (CLL): Final Results of the CLL2-BIG Trial of the German CLL Study Group (GCLLSG) (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4238;
Among 33 pts who discontinued treatment due to MRD negativity only 5 pts relapsed and 1 pt died so far. The data demonstrate that the BIG protocol using an MRD guided concept for treatment discontinuation yields very good results, in particular in 1L CLL pts.
- Venclexta (venetoclax) / Roche, AbbVie
Debulking Eliminates Need for Hospitalization Prior to Initiating Frontline Venetoclax Therapy in Previously Untreated CLL Patients: A Phase 3b Study (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4234;
P3b
Two cycles of obinutuzumab prior to initiation of venetoclax was an effective debulking strategy for patients with ALC >25 × 109 /L and lymph nodes 5 cm treated with obinutuzumab or >10 cm treated with obinutuzumab plus bendamustine may need >2 cycles to achieve low tumor burden. Debulking via obinutuzumab, with or without bendamustine, may allow more patients to be administered venetoclax in the outpatient setting, eliminating the need for hospitalization during venetoclax initiation.
- Rituxan (rituximab) / Roche, Biogen, Imbruvica (ibrutinib) / AbbVie, J&J
Maintenance of Long-Term Undetectable Minimal Residual Disease after Combination of Ibrutinib with Abbreviated Chemotherapy in the Icll-07 Filo Trial (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4230;
P2
Introduction In previously untreated, medically fit patients with chronic lymphocytic leukaemia (CLL) and no 17p deletion, there is current research interest in improving survival outcomes and potentially sparing some patients from the standard 6 cycles of fludarabine, cyclophosphamide and rituximab (FCR)...Otherwise, patients received 4x4‑weekly cycles of fludarabine/cyclophosphamide (FC) and obinutuzumab 1000 mg iv, alongside continuing ibrutinib for 6 additional months (FCGA+I arm)...With longer follow-up, including assessing the evolution of PB MRD, the response is maintained. This strategy could be an option in the first‑line setting, although randomised trial evidence is needed.
- Venclexta (venetoclax) / Roche, AbbVie, Rituxan (rituximab) / Roche, Biogen
Durability of Responses on Continuous Therapy and Following Drug Cessation with Venetoclax and Rituximab: Long-Term Follow-up Analysis of a Phase 1b Study in Patients with Relapsed CLL (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4228;
P1b
These responses are highly durable whether on continuous or limited duration therapy, with treatment-free remissions of >4 yr now being observed . Re-treatment of pts with Ven or VenR re-exposure has resulted in response in some pts .
- Gazyva (obinutuzumab) / Biogen, Roche
Obinutuzumab Alone or Combined with Chemotherapy in Previously Untreated (Fit or Unfit) or Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Patients: Final Results from the Phase IIIb GREEN Safety Study with a Focus on Efficacy (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4227;
P3
Efficacy outcomes suggest a favorable benefit/risk profile in both 1L and R/R CLL, irrespective of chemotherapy regimen. PFS outcome for pts with 12q trisomy, del(13q) and IGHV mutated were favorable across treatment arms, while del(11q), del(17q), and unmutated IGHV showed a worse outcome.
- RG6026 / Roche, Tecentriq (atezolizumab) / Roche
CD20-TCB, a Novel T-Cell-Engaging Bispecific Antibody, Can be Safely Combined with the Anti-PD-L1 Antibody Atezolizumab in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4054;
P1
ASH 2019) . Updated safety, efficacy, and biomarker data will be presented.
- Phase 1b Study of Vipor (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Lenalidomide) in Relapsed/Refractory B-Cell Lymphoma: Safety, Efficacy and Molecular Analysis (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4050;
Heme AEs, mainly neutropenia, were most common and manageable with G-CSF and no neutropenic fever or severe infections occurred. Early signs of clinical activity, including CRs in refractory pts, are observed with ViPOR and further development plans include phase 1 testing in MCL and phase 2 testing in DLBCL and FL.
- Gazyva (obinutuzumab) / Biogen, Roche, Rituxan (rituximab) / Roche, Biogen, bendamustine / SymBio, Mundipharma, Astellas, Generic mfg.
Sustained Overall Survival Benefit of Obinutuzumab Plus Bendamustine Followed By Obinutuzumab Maintenance Compared with Bendamustine Alone in Patients with Rituximab-Refractory Indolent Non-Hodgkin Lymphoma: Final Results of the Gadolin Study (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4002;
P3
There were no new safety signals with longer follow-up. Acknowledgments: The GADOLIN study was sponsored by F. Hoffmann-La Roche Ltd.
- Venclexta (venetoclax) / Roche, AbbVie
Non-Bcl2 Mutations Are Predominant in Patients (pts) with Venetoclax Resistant Mantle Cell Lymphoma (MCL) – Response and Clinical Outcomes in Ultra-Refractory MCL (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_3995;
Combination clinical trials with obinutuzumab, acalabrutinib are ongoing in MCL . We have characterized mutations and aneuploidy abnormalities in venetoclax resistant MCL pts and shown that unlike CLL, Bcl2 mutations are infrequent in venetoclax resistant MCL.
- Rituxan (rituximab) / Roche, Biogen
Recapitulation of Prognostic Mutational Subtyping Utilizing F1H in GOYA and CAVALLI and the Potential to Highlight Benefit of Targeted Therapy in De Novo DLBCL (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_3966;
P1/2, P3
Important findings from the present work include: 1) utility of targeted mutational data from F1H in recapitulating molecular clusters, previously identified using WES, that further subclassify established prognostic groups such as COO and IPI; and 2) a trend towards improved survival outcomes for patients in the BCL2/EZH2 cluster upon treatment with the BCL2 inhibitor venetoclax . This highlights the potential for utilizing novel genetic signatures as a means of identifying patients suitable for targeted therapies in the era of personalized health care.
- Rituxan (rituximab) / Roche, Biogen
Complete Response Status According to RECIL 2017 Criteria Shows High Concordance with Lugano 2014 Criteria and Is Highly Prognostic for Outcome in Previously Untreated Patients with CD20-Positive Diffuse Large B-Cell Lymphoma (DLBCL) (Valencia A (W415A), Level 4 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_3317;
P3
EoT CR status according to RECIL 2017 criteria showed a high concordance with CMR status by Lugano 2014 criteria and was highly prognostic for PFS and OS in previously untreated DLBCL; however, discordance was seen for the identification of PD by RECIL compared with Lugano criteria . PFS as assessed by CT by RECIL, based on uni-dimensional size measurements of up to three target lesions, showed high concordance with PFS by Lugano criteria, based on bi-dimensional size measurements of up to six target lesions.
- Ibrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (iFCG) for First-Line Treatment of IGHV-Mutated CLL and without Del(17p)/Mutated TP53 (Hall E1, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_3103;
P2
Additional infectious complications without neutropenia leading to hospitalization included pneumonia (culture negative) (n=2), cellulitis (n=1), pulmonary MAC infection (n=1), fever (n=1), acute cholecystitis (n=1), and colitis (n=1). CONCLUSIONS The iFCG regimen with only 3 cycles of chemotherapy is an effective time-limited regimen for young pts with M-IGHV and without del(17p)/ mutated TP53.
- Revlimid (lenalidomide) / BMS, Gazyva (obinutuzumab) / Biogen, Roche, Rituxan (rituximab) / Roche, Biogen
A Phase I/II Study of Lenalidomide Plus Obinutuzumab in Relapsed Indolent Lymphoma (Tangerine 3 (WF3-4), Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_3092;
Adverse events appeared similar to our prior experience with lenalidomide and rituximab and were generally well tolerated . Overall response rates were high, with many pts achieving prolonged remission, including pts who had relapsed after 2 or more lines of prior therapy .
- Gazyva (obinutuzumab) / Biogen, Roche, Zydelig (idelalisib) / Gilead
Open Label Non-Randomized Phase II Study Exploring «Chemo-Free » Treatment Association with Idelalisib + Obinutuzumab in Patients with Relapsed/Refractory (R/R) Waldenstrom’s Macroglobulinemia (MW), a Filo Trial: Results of the Intermediary Analysis of the Induction Phase (Tangerine 3 (WF3-4), Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_3090;
P2
Median PFS was 25 months . Most of grade ≥ 3 AE or SAE are hepatotoxicity, diarrhea and neutropenia as expected with idelalisib.
- doxorubicin hydrochloride / Generic mfg., Rituxan (rituximab) / Roche, Biogen, Imbruvica (ibrutinib) / AbbVie, J&J
Updated Meta-Analysis to Evaluate the Incidence of Atrial Fibrillation and Major Bleeding in Patients with Hematologic Malignancies Treated with Ibrutinib (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_3062;
Ibrutinib also contributed to higher risk of major bleeding by 1.73. These results are concordant with our previous findings on ibrutinib and remain persistent.
- Obinutuzumab Plus Gemcitabine, Dexamethasone and Cisplatin (O-GDP) As Salvage Chemotherapy Prior to Autologous Stem Cell Transplant in Aggressive B Cell Lymphoma (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_2880;
Higher rates of cytopenias with O-GDP contributed to treatment delays and dose reductions or holds. Further mutational analysis will be presented.
- Leukeran (chlorambucil) / GSK, Gazyva (obinutuzumab) / Biogen, Roche, Rituxan (rituximab) / Roche, Biogen
Front-Line Treatment with Obinutuzumab ± Chlorambucil for Chronic Lymphocytic Leukemia in Real-World Clinical Practice: Results of a Multinational, Multicenter Study By Eric and Icllsg (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_2608;
The median age of this patient population was 75.9 years; 59.7% were men, median CIRS total score was 8 and estimated creatinine clearance 61.1 mL/min . Seventy four patients had Binet stage A (17.2%), 167 (38.8%) stage B and 190 (44.1%) stage C .
- Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Biogen, Roche, Imbruvica (ibrutinib) / AbbVie, J&J
First Line Treatment with Venetoclax and Ibrutinib Induction Followed By Obinutuzumab Intensification Exclusively in CLL/SLL Patients Not in Complete Remission and/or with Detectable Bone Marrow Minimal Residual Disease (NEXT STEP trial) (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_2595;
Major inclusion criteria Treatment naïve CLL or SLL patients requiring treatment by iwCLL WHO performance status 0-3 Adequate BM function defined as: Hb > 8 g/dL Neutrophil count ≥75 x 109/L Platelet count ≥ 50,000 /μL creatinine clearance ≥ 30ml/min Major exclusion criteria Active fungal, bacterial, and/or viral infection that requires systemic therapy; Patients requiring treatment with strong cytochrome P450 (CYP) 3A inhibitor or with vitamin K antagonists Statistical methods For the primary endpoint analyses, all patients registered and eligible for intensification treatment with ibrutinib+obinutuzumab (not in complete remission and/or uMRD) will be included . Perspective This trial helps in personalizing CLL treatment by selecting sequential time limited therapies guided by MRD.
- Alliance A041702: A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (≥ 70 Years of Age) with Chronic Lymphocytic Leukemia (CLL) (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_2593;
P3
Background The phase 3 trial A041202 solidified the Bruton’s Tyrosine Kinase (BTK) inhibitor ibrutinib as a standard of care for older patients with previously untreated CLL by showing superior progression-free survival (PFS) as compared with bendamustine plus rituximab...Warfarin and strong inhibitors or inducers of CYP3A4/5 are not permitted...The study is expected to accrue for 3 years beginning January 2019, and we welcome participation from sites throughout the NCTN. Support: U10CA180821, U10CA180882, UG1CA189823, U24CA196171; U10CA180820 (ECOG-ACRIN); https://acknowledgments.alliancefound.org; ClinicalTrials.gov Identifier: NCT03737981
- RG6026 / Roche, Gazyva (obinutuzumab) / Biogen, Roche
Dual CD20-Targeted Therapy With Concurrent CD20-TCB and Obinutuzumab Shows Highly Promising Clinical Activity and Manageable Safety in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma: Preliminary Results From a Phase Ib Trial (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_2417;
P1
CD20-TCB plus G provides highly promising clinical activity in heavily pre-treated R/R B-cell NHL . Updated clinical and biomarker data will be presented.
- Gazyva (obinutuzumab) / Biogen, Roche, Rituxan (rituximab) / Roche, Biogen
Rituximab and Obinutuzumab Induce Direct B-Cell Death Via B-Cell Receptor (BCR) Signaling, but Rituximab Elicits Stronger BCR-Derived Pro-Survival Signals Diminishing Apoptosis (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_2411;
Thus, our findings provide a mechanistic rationale for the observations made in clinical trials comparing rituximab and obinutuzumab head-to-head . We believe that our results will help to identify new patient subgroups benefitting from obinutuzumab and to better assess the role of anti-CD20 treatment in combination therapies.
- Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Biogen, Roche, Imbruvica (ibrutinib) / AbbVie, J&J
Ibrutinib, Venetoclax Plus Obinutuzumab in Newly Diagnosed Mantle Cell Lymphoma Patients (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_2360;
P1/2
Ibrutinib/Venetoclax/Obinutuzumab combination therapy has a very good safety profile and shows high efficacity rates at the molecular level in untreated patients . Oasis step C is the first trial that report the use of Ibrutinib/Venetoclax/Obinutuzumab as frontline therapy in MCL.
- Rituxan (rituximab) / Roche, Biogen
Transcriptomic and Metabolomic Profiling Identifies Calcium-Dependent Signaling Mechanisms As a Novel and Exploitable Target to Overcome Anti-CD20 Resistance in Non-Hodgkin Lymphoma (NHL) (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_2340;
Furthermore, rational multi-targeting of cellular voltage potential with BTK signaling, autophagy, and proteasomal activity resulted in CD20 re-expression and prominent enhancement of cell death in resistant NHL cells. Collectively, these data suggest that small molecule compounds targeting ionic signaling, many of which are already approved for human use, may be harnessed as novel cancer therapies.
- Rituxan (rituximab) / Roche, Biogen, Imbruvica (ibrutinib) / AbbVie, J&J
Early Adoption and Outcomes of Ibrutinib As Treatment for Older Patients with Chronic Lymphocytic Leukemia (CLL): A Population-Based Study (W308, Level 3 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_1639;
Despite high OOP costs, the use of first-line ibrutinib is not associated with sociodemographic characteristics, suggesting that therapeutic decisions are determined by clinical factors. The real-world survival of older patients on ibrutinib is poorer than seen in clinical trials, and rates of AFib, VArr and CNSh are higher.
- Polivy (polatuzumab vedotin) / Roche, Seattle Genetics, Revlimid (lenalidomide) / BMS, Gazyva (obinutuzumab) / Biogen, Roche
Polatuzumab Vedotin Plus Obinutuzumab and Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma: Primary Analysis of the Full Efficacy Population in a Phase Ib/II Trial (Hall E2, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_1433;
P1
This first report of the full efficacy population showed high CR rates at EOI in a heavily pre-treated and refractory population, which compares favorably with currently available R/R FL therapies . These compelling findings support the further investigation of this triplet combination in a larger pt population .
- Revlimid (lenalidomide) / BMS, Gazyva (obinutuzumab) / Biogen, Roche
Results of a Phase II Study of Obinutuzumab in Combination with Lenalidomide in Previously Untreated, High Tumor Burden Follicular Lymphoma (FL) (Hall E2, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_1432;
The toxicity profile was manageable . Further study of this effective, immune therapy approach in untreated FL is warranted.
- Rituxan (rituximab) / Roche, Biogen
Evaluation of the m7-FLIPI in Patients with Follicular Lymphoma Treated within the Gallium Trial: EZH2 mutation Status May be a Predictive Marker for Differential Efficacy of Chemotherapy (Hall E2, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_1429;
However, the m7-FLIPI was not prognostic in patients treated with Bendamustine-based regimens. While EZH2 mutation status was associated with longer PFS in patients receiving CHOP/CVP regimens (with either R or G), it did not impact treatment outcome of patients treated with Bendamustine, suggesting that EZH2 mutation status is a predictive marker for differential efficacy of the chemotherapy regimen.
- Venclexta (venetoclax) / Roche, AbbVie, Leukeran (chlorambucil) / GSK, Gazyva (obinutuzumab) / Biogen, Roche
Quantitative Analysis of Minimal Residual Disease (MRD) Shows High Rates of Undetectable MRD after Fixed-Duration Chemotherapy-Free Treatment and Serves As Surrogate Marker for Progression-Free Survival: A Prospective Analysis of the Randomized CLL14 Trial (Hall D, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_1317;
Findings confirm the prognostic value of MRD assessment at EOT for this chemotherapy-free treatment regimen . Due to high concordance of undetectable MRD in PB and BM in the context of VenG, BM assessments may not be required for these patients.
- Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Biogen, Roche, Calquence (acalabrutinib) / AstraZeneca
Preliminary Safety and Efficacy Results from a Phase 2 Study of Acalabrutinib, Venetoclax and Obinutuzumab in Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) (Hall D, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_1313;
P2, P3
Based on our initial results we have opened an expansion cohort to further characterize the efficacy and safety of AVO . AVO will also be studied head-to-head against chemoimmunotherapy and the AV doublet in the phase 3 trial CL-311 (NCT03836261), which is currently enrolling.
- Gazyva (obinutuzumab) / Biogen, Roche, Calquence (acalabrutinib) / AstraZeneca
ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL) (Hall D, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_1312;
P3
Acalabrutinib + O and acalabrutinib monotherapy significantly improved PFS vs O + Clb, with tolerable safety in pts with TN CLL . Despite cross over for disease progression in the O + Clb arm, a trend toward improved OS was observed in both acalabrutinib arms, though longer follow-up is needed.
- ||||| Gazyva (obinutuzumab) / Biogen, Roche, Calquence (acalabrutinib) / AstraZeneca
ASH abstracts are online!! ELEVATE-TN trial showing outcomes of acalabrutinib with or without obinutuzumab in treatment-naive CLL. 30-mos PFS 90% for Acala+ O, 82% Acala mono. Food for thought. Proud to be a co-author on this study. @jeff_sharman @NovantHealth @JTCancerCenter (Twitter) - Nov 6, 2019
- || Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy: A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL) (clinicaltrials.gov) - Nov 2, 2019
P1/2, N=140, Active, not recruiting, Sponsor: Hoffmann-La Roche
Despite cross over for disease progression in the O + Clb arm, a trend toward improved OS was observed in both acalabrutinib arms, though longer follow-up is needed. Recruiting --> Active, not recruiting | Trial completion date: Oct 2022 --> Apr 2020 | Trial primary completion date: Oct 2022 --> Apr 2020
- | Revlimid (lenalidomide) / Celgene, Gazyva (obinutuzumab) / Biogen, Roche, Rituxan (rituximab) / Roche, Biogen
Clinical, P2 data, Journal: Obinutuzumab combined with lenalidomide for relapsed or refractory follicular B-cell lymphoma (GALEN): a multicentre, single-arm, phase 2 study. (Pubmed Central) - Oct 31, 2019
P1/2
Our data shows that lenalidomide plus obinutuzumab is active in previously treated patients with relapsed or refractory follicular lymphoma, including those with early relapse, and has a manageable safety profile. Randomised trials of new immunomodulatory regimens, such as GALEN or using GALEN as a backbone, versus lenalidomide plus rituximab, are warranted.
- | Gazyva (obinutuzumab) / Biogen, Roche, Imbruvica (ibrutinib) / AbbVie, J&J
Clinical, P2 data, Journal, Residual disease: Obinutuzumab and ibrutinib induction therapy followed by a minimal residual disease-driven strategy in patients with chronic lymphocytic leukaemia (ICLL07 FILO): a single-arm, multicentre, phase 2 trial. (Pubmed Central) - Oct 31, 2019
P2
Obinutuzumab and ibrutinib induction therapy followed by a minimal residual disease driven strategy is safe and active in patients with previously untreated chronic lymphocytic leukaemia. With longer follow-up, including assessing the evolution of minimal residual disease, if response is maintained, this strategy could be an option in the first-line setting in patients with chronic lymphocytic leukaemia, although randomised evidence is needed.
- | Rituxan (rituximab) / Roche, Biogen
Biomarker, Journal, IO Biomarker: New developments in the treatment of follicular lymphoma. (Pubmed Central) - Oct 28, 2019
Recent data suggest that the immunomodulatory agent lenalidomide can also be effective in combination with rituximab in both the upfront and relapsed setting...Current information suggests that the most important prognostic feature of FL is the presence or absence of early progression (within 2 years of initial treatment/diagnosis). Ongoing efforts are focused on biomarkers to optimally match treatment to patient populations and further improve clinical outcomes.
- || Columvi (glofitamab-gxbm) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment change, 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) - Oct 27, 2019
P1, N=620, Recruiting, Sponsor: Hoffmann-La Roche
Ongoing efforts are focused on biomarkers to optimally match treatment to patient populations and further improve clinical outcomes. N=260 --> 620
- Gazyva (obinutuzumab) / Biogen, Roche, Rituxan (rituximab) / Roche, Biogen
OBINUTUZUMAB IN PEDIATRIC IDIOPATHIC NEPHROTIC SYNDROME RESISTANT TO RITUXIMAB () - Oct 25, 2019 - Abstract #IPNA2019IPNA_16;
OBZ induced peripheral B-cell depletion in SD/FRNS patients resistant to rituximab. A single low dose injection resulted in longer B-cell depletion compared to rituximab.
- | Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Review, Journal: An Evidence-based Review of Anti-CD20 Antibody-containing Regimens for the Treatment of Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Diffuse Large B-cell Lymphoma, or Follicular Lymphoma. (Pubmed Central) - Oct 24, 2019
Thus, the available data are inconclusive regarding any potential similarities or differences in efficacy among these anti-CD20 agents for each respective disease. More importantly, only 1 direct comparison among the anti-CD20 agents was identified, emphasizing the need for head-to-head randomized controlled trials of these drugs to inform clinical decision-making for patients with relapsed or refractory B-cell lymphoproliferative disorders.
- | Gazyva (obinutuzumab) / Biogen, Roche
Clinical, P1 data, Journal: Durable remissions with obinutuzumab-based chemoimmunotherapy: long-term follow-up of the phase 1b GALTON trial in CLL. (Pubmed Central) - Oct 24, 2019
More importantly, only 1 direct comparison among the anti-CD20 agents was identified, emphasizing the need for head-to-head randomized controlled trials of these drugs to inform clinical decision-making for patients with relapsed or refractory B-cell lymphoproliferative disorders. No abstract available
- Novel therapy for relapsed childhood acute lymphoblastic leukemia () - Oct 23, 2019 - Abstract #EHOC2019EHOC_7;
Since bcl-2 pathway prevents apoptosis, the efficacy of bcl-2 inhibitors, Navitoclax and Venetoclax, in ALL is being investigated...Palbociclib, CDK6 inhibitor, is used as monotherapy in KMT2A-r acute leukemia...Immunotherapy Antibody-based immunotherapy Blinatumomab: It is an antibody capable of binding to CD19 and CD3 and transmitting T-cell cytotoxicity to lymphoblasts presenting CD19...Denintuzumab mafodatin: It is a humanized CD19 antibody bound with monomethyl auristatin F (MMAF)...ADCT-402: It is a humanized anti-CD19 antibody conjugated with Pyrrolobenzodiazepine dimer cytotoxin...DT2219: It is a bispecific, recombinant, diphtheria toxin-based immunotoxin that recognizes CD19 and CD22-presenting cells...Inotuzumab ozogamicin: It is a novel monoclonal antibody against CD22 conjugated to the toxin Calicheamicin...Epratuzumab: It is a humanized monoclonal anti-CD22 antibody...Rituximab: It is a chimeric monoclonal CD20 antibody...Ofatumumab: It is a humanized anti-CD20 antibody...Obinutuzumab: It a type II humanized anti-CD20 monoclonal antibody...Etanercept (anti-TNF) and Tociluzumab (anti IL-6) can be used in the treatment of cytokine release syndrome. There are many marching studies on CAR-T cell therapy.
- Rituxan (rituximab) / Roche, Biogen
New drugs for CLL () - Oct 23, 2019 - Abstract #EHOC2019EHOC_3;
P1/2
LIkewise, a loinger PFS was observed in the ibrutinib arms in 2 trials comparing ibrutinib with bendamustine and rituximab or chlorambucil and obinutuzumab [5,6]...The phase 3 RESONATE trial compared single-agent ibrutinib to ofatumumab in 391 patients with relapsed/refractory CLL (ibrutinib n=195, ofatumumab n=196) with a median age of 67 (≥70 40% and 41% in the two group respectively) [7]...This is a randomized, multicenter, open-label phase 3 trial which evaluated efficacy and safety of acalabrutinib monotherapy vs investigator choice therapy (Rituximab plus Idelalisib or Bendamustine) in R/R CLL...In a phase 2 trial [20] ibrutinib was combined with fludarabine, cyclophosphamide and obinutuzumab (iFCG) 32 previously untreated CLL patients with M-IGHV and without TP53 disruption received this combination...The long-term experience with ibrutinib single agent until progression is very positive and fixed duration treatment with venetoclax and rituximab is a new paradigm for treatment of CLL. Combination treatment (CIT + ibrutinib or venetoclax combined with ibrutinib) are very promising regimens.
- | Enrollment open: NP39488: An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov) - Oct 22, 2019
P1, N=140, Recruiting, Sponsor: Hoffmann-La Roche
Combination treatment (CIT + ibrutinib or venetoclax combined with ibrutinib) are very promising regimens. Active, not recruiting --> Recruiting
- | Enrollment open, Combination therapy: NP40126: A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL (clinicaltrials.gov) - Oct 21, 2019
P1b, N=172, Recruiting, Sponsor: Hoffmann-La Roche
Active, not recruiting --> Recruiting Active, not recruiting --> Recruiting
- | Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Zydelig (idelalisib) / Gilead
Enrollment closed: Sequential Regimen of Bendamustine-Debulking Followed by CAL-101 and GA101-Induction and -Maintenance in CLL (CLL2-BCG) (clinicaltrials.gov) - Oct 20, 2019
P2, N=48, Active, not recruiting, Sponsor: German CLL Study Group
Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting
- Gazyva (obinutuzumab) / Biogen, Roche, Imbruvica (ibrutinib) / AbbVie, J&J
Oncology Nursing Experience in Phase 3 iLLUMINATE: First-Line Ibrutinib-Obinutuzumab Versus Chlorambucil-Obinutuzumab for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) () - Oct 20, 2019 - Abstract #AONNNSC2019AONN_NSC_106;
P3
First-line combination therapy with ibrutinib-obinutuzumab represents an effective chemotherapy-free regimen for patients with CLL and is associated with significantly improved PFS and fewer IRRs versus chlorambucil-obinutuzumab. Oncology nurses play critical roles in educating patients, monitoring AEs, and supporting the management of patients receiving continuous ibrutinib therapy to help achieve maximal treatment benefit.
- | Ukoniq (umbralisib) / TG Therap, Gazyva (obinutuzumab) / Roche, Biogen
Trial suspension: SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov) - Oct 17, 2019
P2, N=150, Suspended, Sponsor: National Cancer Institute (NCI)
Oncology nurses play critical roles in educating patients, monitoring AEs, and supporting the management of patients receiving continuous ibrutinib therapy to help achieve maximal treatment benefit. Recruiting --> Suspended
- ||| Gazyva (obinutuzumab) / Biogen, Roche
“For CLL, I think we should be keeping obinutuzumab first and foremost in our mind,” says our @wwierda of treatment options for chronic lymphocytic #leukemia. #leusm #endcancer (Twitter) - Oct 15, 2019
- | Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date, Trial termination, Trial primary completion date: CLLTX1: Obinutuzumab Containing Conditioning Regimen for Patients With Poor Risk CLL or Richter's Transformation Requiring Allogeneic Stem Cell Transplantation (clinicaltrials.gov) - Oct 15, 2019
P2, N=3, Terminated, Sponsor: German CLL Study Group
Recruiting --> Suspended Trial completion date: Jun 2021 --> Jun 2019 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2020 --> May 2019; Prematurely terminated due to poor accrual
- Gazyva (obinutuzumab) / Biogen, Roche
A Phase 2 Randomized, Controlled Study of Obinutuzumab with Mycophenolate and Corticosteroids in Proliferative Lupus Nephritis (Ballroom C, Walter E. Washington Convention Center) - Oct 14, 2019 - Abstract #KIDNEYWEEK2019KIDNEY_WEEK_5179;
- Darzalex IV (daratumumab) / J&J, Gazyva (obinutuzumab) / Biogen, Roche, Rituxan (rituximab) / Roche, Biogen
A Global Anti B-Cell Strategy with Obinutuzumab and Daratunumab in Severe Pediatric Idiopathic Nephrotic Syndrome (152, Walter E. Washington Convention Center) - Oct 14, 2019 - Abstract #KIDNEYWEEK2019KIDNEY_WEEK_4899;
Conclusion Global anti-B cell strategy with obinutuzumab and daratumumab induces prolonged peripheral B-cell depletion and nephrotic syndrome remission in children with severe SDNS. However, it induces frequent and profound hypogammaglobulinemia and further investigation of the safety and the long-term efficacy of this strategy is needed.