- |||||||||| Calquence (acalabrutinib) / AstraZeneca
Enrollment closed, Trial completion date, Combination therapy, Monotherapy: ELEVATE-TN: Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment na (clinicaltrials.gov) - Jan 10, 2023
P3, N=535, Active, not recruiting,
Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Jun 2024 Unknown status --> Active, not recruiting | Trial completion date: Jul 2021 --> Sep 2025
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Tecentriq (atezolizumab) / Roche
Trial completion: LYSA: Evaluation of Atezolizumab-Venetoclax-Obinutuzumab Combination in Relapse/Refractory Lymphomas (clinicaltrials.gov) - Jan 10, 2023
P2, N=136, Completed,
Unknown status --> Active, not recruiting | Trial completion date: Jul 2021 --> Sep 2025 Active, not recruiting --> Completed
- |||||||||| Ukoniq (umbralisib) / TG Therap, Gazyva (obinutuzumab) / Roche, Biogen
Trial completion date, Trial primary completion date: 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) - Jan 9, 2023
P2, N=95, Suspended,
Active, not recruiting --> Completed Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| Darzalex (daratumumab) / J&J, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
CHAGAS REACTIVATION DURING DESENSITIZATION FOR ORTHOTOPIC HEART TRANSPLANTATION (Poster Hall_Hall F) - Jan 4, 2023 - Abstract #ACCWCC2023ACC_WCC_1491;
Reactivation has significant consequences and may prohibit transplant candidacy. Further research is needed to better understand which desensitization regimens carry the greatest risk for Chagas reactivation.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Polivy (polatuzumab vedotin-piiq) / Roche
P1 data, Preclinical, Journal: Targeting MCL-1 and BCL-2 with polatuzumab vedotin and venetoclax overcomes treatment resistance in R/R NHL: Results from preclinical models and a Phase Ib study. (Pubmed Central) - Jan 4, 2023
P1
This targeted MCL-1 antagonism, when combined with venetoclax and the anti-CD20 antibodies obinutuzumab or rituximab, results in tumor regressions in preclinical NHL models, which are sustained even off-treatment. In a Phase Ib clinical trial (NCT02611323) of heavily pre-treated patients with relapsed or refractory NHL, 25/33 (76%) patients with follicular lymphoma and 5/17 (29%) patients with diffuse large B-cell lymphoma achieved complete or partial responses with an acceptable safety profile when treated with the recommended Phase II dose of polatuzumab vedotin in combination with venetoclax and an anti-CD20 antibody.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Trial completion date, Trial initiation date, Trial primary completion date: PR3-AAV Resilient Remission or PRRR (clinicaltrials.gov) - Jan 3, 2023
P2, N=30, Not yet recruiting,
Trial completion date: Apr 2025 --> Sep 2025 Trial completion date: Jul 2024 --> Jul 2025 | Initiation date: Nov 2022 --> Mar 2023 | Trial primary completion date: Jan 2024 --> Jan 2025
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Prolonged SARS-CoV-2 Infection With Common Features in Two Patients Receiving Anti-CD20 Therapy. (Pubmed Central) - Jan 3, 2023
Trial completion date: Jul 2024 --> Jul 2025 | Initiation date: Nov 2022 --> Mar 2023 | Trial primary completion date: Jan 2024 --> Jan 2025 These two cases highlight the risk for persistent SARS-CoV-2 infection in patients treated with anti-CD20 monoclonal antibodies and support a role for cellular immunity recovery for disease control.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Roche
Trial completion date, Trial primary completion date: 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) - Dec 27, 2022
P3, N=165, Recruiting,
These two cases highlight the risk for persistent SARS-CoV-2 infection in patients treated with anti-CD20 monoclonal antibodies and support a role for cellular immunity recovery for disease control. Trial completion date: May 2024 --> Jun 2025 | Trial primary completion date: Aug 2023 --> Mar 2024
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Jaypirca (pirtobrutinib) / Eli Lilly, Gazyva (obinutuzumab) / Roche, Biogen
Enrollment open: Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-na (clinicaltrials.gov) - Dec 23, 2022
P2, N=60, Recruiting,
Trial completion date: May 2024 --> Jun 2025 | Trial primary completion date: Aug 2023 --> Mar 2024 Not yet recruiting --> Recruiting
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal: CD20/TNFR1 dual-targeting antibody enhances lysosome rupture-mediated cell death in B cell lymphoma. (Pubmed Central) - Dec 20, 2022
Obinutuzumab is a therapeutic antibody for B cell non-Hodgkin's Lymphoma (BNHL), which is a glyco-engineered anti-CD20 antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and causes binding-induced direct cell death (DCD) through lysosome membrane permeabilization (LMP)...Further, OBI-TNFα blocked NF-κB activation in the presence of TNF-α, implying that it can antagonise the proliferative role of TNF-α in cancers.Our study suggests that dual targeting of CD20 and TNFR1 can be a new therapeutic strategy for improving BNHL treatment. The OBI-TNFα fusion protein enhances DCD and ADCC and prevents the proliferating effect of TNFα signalling; therefore, it may provide precision treatment for patients with BNHL, especially those with upregulated TNFR1 expression.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Imbruvica (ibrutinib) / AbbVie, J&J
Enrollment open, Trial completion date, Trial primary completion date: Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System (clinicaltrials.gov) - Dec 20, 2022
P1, N=12, Recruiting,
The OBI-TNFα fusion protein enhances DCD and ADCC and prevents the proliferating effect of TNFα signalling; therefore, it may provide precision treatment for patients with BNHL, especially those with upregulated TNFR1 expression. Suspended --> Recruiting | Trial completion date: Jun 2028 --> Mar 2034 | Trial primary completion date: Dec 2027 --> Mar 2024
- |||||||||| Poteligeo (mogamulizumab) / Kyowa Kirin, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
HBV Reactivation and Immunosuppressive Therapy (4F VIP Room) - Dec 18, 2022 - Abstract #APASL2023APASL_113;
Suspended --> Recruiting | Trial completion date: Jun 2028 --> Mar 2034 | Trial primary completion date: Dec 2027 --> Mar 2024 While HBV reactivation has been reported with some cytotoxic chemotherapies (eg, anthracyclines) and high-dose corticosteroids, the highest rates (approximately 10%) of reactivation are typically observed during immunochemotherapy with the anti-CD20 monoclonal antibody, rituximab, especially when it is combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy...A retrospective study showed that the overall incidence of HBV reactivation (confirmed, quantifiable HBV DNA ?29 IU/mL) was 8.2% among the 326 patients with resolved infection who received obinutuzumab-containing chemotherapy in the global phase 3 GOYA (diffuse large B-cell lymphoma; CHOP-backbone) and GALLIUM (follicular lymphoma; bendamustine or CHOP or CVP-backbone) studies (Kusumoto S, et al...This depletion might result in a rapid provocation of the patient
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
New P2 trial, Minimal residual disease: Zanubrutinib and Venetoclax as Initial Therapy for Chronic Lymphocytic Leukemia (CLL) With Response-based Obinutuzumab (clinicaltrials.gov) - Dec 14, 2022
P2, N=50, Not yet recruiting,
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
A study by Christine Ryan, MD, and @DrMDavids highlights the effectiveness of the Acalabrutinib, Venetoclax, Obinutuzumab combination in frontline treatment for #CLL. #ASH22 https://t.co/cpgqjYHnpd (Twitter) - Dec 11, 2022
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal, IO biomarker: Selecting initial therapy in CLL. (Pubmed Central) - Dec 10, 2022
Treatment selection is driven by patient-, treatment-, and disease-related factors, encompassing patient preference, concomitant medications, comorbidities, safety profile of the regimen, and TP53 aberration. Clinical trials are actively investigating the simultaneous inhibition of Bruton's tyrosine kinase (BTK) and B-cell lymphoma 2 (BCL-2) proteins with or without a CD20 monoclonal antibody, which can achieve deep response in most patients (52%-89% undetectable minimal residual disease in bone marrow).
- |||||||||| Trial completion date, Trial primary completion date, Combination therapy: Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma (clinicaltrials.gov) - Dec 6, 2022
P1, N=32, Recruiting,
Although continuous IB provides better disease control in CLL, IGHV mutated patients and those achieving an undetectable MRD show a marked clinical and economic benefit from a fixed-duration obinutuzumab-based treatment. Trial completion date: Sep 2027 --> Jul 2028 | Trial primary completion date: Apr 2023 --> Jul 2023
- |||||||||| Columvi (glofitamab-gxbm) / Roche, englumafusp alfa (RG6076) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date, Trial primary completion date, Combination therapy: A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of RO7227166 in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab Administered in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov) - Dec 6, 2022
P1, N=420, Recruiting,
Trial completion date: Sep 2027 --> Jul 2028 | Trial primary completion date: Apr 2023 --> Jul 2023 Trial completion date: Jan 2023 --> Mar 2025 | Trial primary completion date: Jan 2023 --> Mar 2025
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Enrollment closed, Trial completion date: Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL (clinicaltrials.gov) - Dec 6, 2022
P2, N=72, Active, not recruiting,
Trial completion date: Jan 2023 --> Mar 2025 | Trial primary completion date: Jan 2023 --> Mar 2025 Recruiting --> Active, not recruiting | Trial completion date: Jul 2026 --> Dec 2027
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Prevalence and Treatment of patients with different types of Non-Hodgkin Lymphoma in Germany () - Nov 30, 2022 - Abstract #DKK2022DKK_2291;
In 2020, the most commonly received therapies in prevalent CLL patients were ibrutinib, mono (8.9 %), venetoclax, mono (2.7 %), and rituximab + bendamustine (R-Benda) (1.8 %)...5.1 % received obinu- tuzumab, mono and 2.4 % obinutuzumab + bendamustine (G-Benda)... This study may serve as a starting point for future longitudi- nal analyses describing treatment pathways.
- |||||||||| Rixathon (rituximab biosimilar) / Kyowa Kirin, Novartis, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
The effects of switching anti-CD20 antibodies on treatment response and outcome for patients with B-Non-Hodgkin lymphomas: A single-center retrospective data analysis (Room A2) - Nov 30, 2022 - Abstract #DKK2022DKK_1765;
Anti-CD20 treatment consisted of 48.2% Mabthera, 34.8% Rixathon, 9.2% Mabthera s.c. 7.8% Obinutuzumab. A switch of Mabthera to the biosimilar Rixathon leads to comparable outcomes and can be done safely in clinical routine.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Review, Journal: Chronic lymphocytic leukemia treatment algorithm 2022. (Pubmed Central) - Nov 30, 2022
The CLL-International Prognostic Index (CLL-IPI) remains the best-validated tool in predicting the time to first therapy among previously untreated patients, which guides selection for early intervention efforts. This review summarizes our current approach to the management of CLL, right from the time of diagnosis through relapsed disease.
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Anti-CD 19 CAR-T Cell Therapy with Tisagenlecleucel for Ritcher Syndrome () - Nov 29, 2022 - Abstract #ASH2022ASH_7826;
She received high dose chemotherapy with R-BEAM followed by autologous stem cell transplant, followed by 4 cycles of maintenance brentuximab given every 3 weeks for her CD30 positive large B cell lymphoma...Treatment was complicated by grade 1-2 cytokine release syndrome (CRS) (treated with tocilizumab and dexamethasone) requiring brief hospitalization...Venetoclax was added to ibrutinib and later, 2 cycles of Obinutuzumab were also given...She received 6 cycles of RCHOP in addition to venetoclax/ibrutinib but end of treatment PET showed disease progression...She received lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by CAR-T cell infusion with tis-cel 3.7 x 10^8 cells anti CD19 CAR-T cells on 6/7/21...She continues to be in CR now 1 year since her CAR-T cell infusion.Conclusion CAR-T cell therapy with Tisagenlecleucel shows promising activity in patients with RS. It is an evolving treatment strategy and more follow up is needed to assess the durability of the responses observed in these patients.
- |||||||||| Systematic Review and Network Meta-Analysis of Frontline Targeted Therapy in Chronic Lymphocytic Leukemia Shows Comparable Efficacy but Distinct Toxicity () - Nov 29, 2022 - Abstract #ASH2022ASH_7629;
Establishing the absence of significant difference in efficacy of frontline targeted therapies in CLL allows the clinician and patient to select therapy based on other factors, namely planned duration, toxicity profile, medication interactions, and cost.Figure 1. 24-month PFS Network and Forest Plot1Chl = Chlorambucil; Acal = Acalabrutinib; Acal/Obin = Acalabrutinib/Obinutuzumab; BR = Bendamustine/Rituximab; Chl/Ofa = Chlorambucil/Ofatumumab; Chl/Ritux = Chlorambucil/Rituximab; Chl/Ritux + Mtn = Chlorambucil/Rituximab + maintenance Rituximab; Flu = Fludarabine; Ibr = Ibrutinib; Ibr/Obin = Ibrutinib/Obinutuzumab; Ibr/Ritux = Ibrutinib/Rituximab; Ibr/Ven = Ibrutinib/Venetoclax; Ven/Obin = Venetoclax/Obinutuzumab; Zan = Zanubrutinib
- |||||||||| Yinuokai (orelabrutinib) / InnoCare, Biogen, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (OFCG) for First-Line Treatment of Chronic Lymphocytic Leukemia: A Multicenter, Investigator-Initiated Study (cwCLL-001 study) () - Nov 29, 2022 - Abstract #ASH2022ASH_7628;
We will update the first efficacy evaluation reporting of 10 patients at this ASH. Conclusion s : Enrollment, treatment and follow up continues.
- |||||||||| Long-Term Analysis of Anti-CD20mab + HDMP for the Treatment of Patients with Chronic Lymphocytic Leukemia () - Nov 29, 2022 - Abstract #ASH2022ASH_7625;
All Pts received anti-microbial prophylaxis consisting of fluconazole, bactrim and acyclovir...Patients without progression at 36 months were found to have higher serum IgA levels. While the Tx landscape for CLL has dramatically changed, the addition of HDMP to an anti-CD20 mAB can be a Tx option for patients desiring short course of Tx, requiring bridging to more definite therapy, or debulking strategy prior to venetoclax based Tx.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Relapsed Chronic Lymphocytic Leukemia Presenting with a Cardiac Mass: A Case Report () - Nov 29, 2022 - Abstract #ASH2022ASH_7614;
(Posch et al., 2021) (Nnaoma et al., 2019) (Goncalves et al., 2002) Extramedullary CLL disease suggests a more aggressive disease and warrants a high level of suspicion for diagnosis. (Ratterman et al., 2014)
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
The Downgraded Lymphoma: Case Series of High-Grade Lymphoma Relapsing As a Low-Grade after Treatment () - Nov 29, 2022 - Abstract #ASH2022ASH_7463;
The patient evolved with splenomegaly and cytopenia, being diagnosed with a splenic MZL with bone marrow infiltration in June 2017 but kept on watch and wait.Extra Case: a 45-yo male with a previous 2007 diagnosis of MCL treated with 4 cycles of Hyper-CVAD (cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine) followed by ASCT in 2008, with no maintenance afterwards...More studies should verify the possibility of low-grade DLBCL transformation and what prognosis this downgrading would bring to the patient. Comparison of pre and post-transformation biopsy material from the same individual is a prerequisite for understanding the molecular mechanisms of phenotypic changes in lymphoma.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
A Phase II Trial of the Combination of Obinutuzumab, Venetoclax, and Ibrutinib in Patients with Previously Untreated Follicular Lymphoma () - Nov 29, 2022 - Abstract #ASH2022ASH_7385;
The other 5 patients remain on treatment.Conclusion : Although the sample size and duration of follow-up were limited, the combination of obinutuzumab, venetoclax, and ibrutinib demonstrated remarkable efficacy and is a promising non-chemotherapeutic alternative for untreated FL. Non-hematologic toxicities were manageable, and no hematologic toxicity led to clinical complications.
|
