- |||||||||| Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
A Phase 3, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of Inebilizumab in IgG4-Related Disease (MITIGATE): Primary Efficacy and Safety Findings (Room 144ABC; In Person) - Sep 25, 2024 - Abstract #ACRConvergence2024ACR_Convergence_901;
P3
Corticosteroids were normalized to 20 mg/day prednisone at the time of randomization and were tapered to discontinuation at the end of study Week 8. The MITIGATE trial, the first randomized, double-blind, placebo-controlled study ever conducted in IgG4-RD, establishes the safety and efficacy of CD19-targeted B cell depletion with inebilizumab in IgG4-RD.
- |||||||||| Opdivo (nivolumab) / BMS
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy, Surgery: Induction Chemo-Nivo in Unresectable Stage III NSCLC (clinicaltrials.gov) - Sep 25, 2024
P2, N=1, Terminated,
The MITIGATE trial, the first randomized, double-blind, placebo-controlled study ever conducted in IgG4-RD, establishes the safety and efficacy of CD19-targeted B cell depletion with inebilizumab in IgG4-RD. N=37 --> 1 | Trial completion date: Aug 2027 --> Jul 2024 | Recruiting --> Terminated | Trial primary completion date: Jun 2025 --> Jul 2024; Slow accrual
- |||||||||| Hengqu (hetrombopag) / Jiangsu Hengrui Pharma
Enrollment closed: Herombopag Added to Cyclosporine in Non Severe Aplastic Anemia (clinicaltrials.gov) - Sep 25, 2024
P2, N=54, Active, not recruiting,
N=37 --> 1 | Trial completion date: Aug 2027 --> Jul 2024 | Recruiting --> Terminated | Trial primary completion date: Jun 2025 --> Jul 2024; Slow accrual Recruiting --> Active, not recruiting
- |||||||||| uproleselan sodium (APL-106) / GlycoMimetics
Trial completion date, Trial primary completion date, Combination therapy: NCI-2021-10020: Highest Dose of Uproleselan in Combination With Fludarabine and Cytarabine for Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Mixed Phenotype Acute Leukemia Relapsed or Refractory and That Expresses E-selectin Ligand on the Cell Membrane (clinicaltrials.gov) - Sep 24, 2024
P1, N=22, Active, not recruiting,
Recruiting --> Active, not recruiting Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
- |||||||||| Rituxan (rituximab) / Roche
Results of Haploidentical Transplant in Wiskott-Aldrich Syndrome Patients with Donor Specific Antibodies: A Case Report (Exhibition Hall (3F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_319;
He received a combination therapy of five consecutive therapeutic plasma exchanges, IVIG and rituximab, due to the antibodies against donor HLA class I and II...Haploidentical HSCT with T-cell depletion (CD3/CD45RA depletion) and myeloablative conditioning (busulfan, fludarabine, ATG, and thiotepa) had been done using his father as the donor...We used cyclosporine A for the prevention of graft-vs-host disease...Suppose you have to do haplo-HSCT from donors with HLA antigens corresponding to high levels of DSA. In that case, recipients should be treated with appropriate therapy to improve donor stem cell engraftment.
- |||||||||| Darzalex (daratumumab) / J&J
The Efficacy of ATRA Pretreatment with eNK Cells and Daratumumab on CD44+ Myeloma Cells (Exhibition Hall (3F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_255;
Additionally, we showed that a low dose of ATRA reduced CD44 expression as well as improving the effectiveness of killing myeloma when combined with NK cells and daratumumab treatment. These findings contribute to future development of NK-based therapy for MM.
- |||||||||| Soliris (eculizumab) / AstraZeneca, Defitelio (defibrotide) / IRCCS San Raffaele Hospital, Jazz, Rituxan (rituximab) / Roche
Preventive and Treatment Strategy of VOD and TA-TMA in Korea (Room A (2F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_194;
Novel targeted therapies like eculizumab are being investigated...In conclusion, implementation of risk-adapted prophylaxis, updated diagnostic criteria, and early treatment have improved outcomes for VOD and TA-TMA in Korea. Further research is needed to optimize prevention and treatment strategies for these life-threatening complications.
- |||||||||| Practical Challenges in Korea (Room C (1F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_191;
Although the United States Food and Drug Administration (US FDA) has approved six CAR T-cell therapies (axicabtagene ciloleucel, brexucabtagene autoleucel, idecabtagene vicleucel, lisocabtagene maraleucel, tisagenlecleucel, and ciltacabtagene autoleucel), only one (tisa-cel) is currently available in Korea. This session will explore the practical challenges surrounding CAR T-cell therapy in South Korea, including patient accessibility, cost-related concerns, reimbursement-related challenges, and the issue of managing CAR T-cell therapy-related toxicities.
- |||||||||| Changing the Treatment Landscape with CART Cells in Patients with B-Cell Lymphomas (Room C (1F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_190;
This session will explore the practical challenges surrounding CAR T-cell therapy in South Korea, including patient accessibility, cost-related concerns, reimbursement-related challenges, and the issue of managing CAR T-cell therapy-related toxicities. So far, four CD19-directed CAR-T therapies (Yescarta
- |||||||||| Darzalex (daratumumab) / J&J
Autologous Stem Cell Mobilization and Transplantation for Multiple Myeloma - Current Status and Future Perspectives in Japan - (Room A (2F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_165;
IFM/DFCI group reported that triplet induction (bortezomib, lenalidomide, and dexamethasone) followed by up-front high-dose melphalan and autologous stem-cell transplantation (HDM/ASCT) and maintenance therapy lead to median PFS of 50 months...The use of lenalidomide before stem cell mobilization is known to reduce the amount of collected CD34-positive cells and concomitant use of plerixafor with G-CSF is recommended...Daratumumab, lenalidomide, and dexamethasone have also been reported to prolong PFS for newly diagnosed transplant-ineligible MM...On the other hands, the success of CAR-T therapy revealed that cellular immunotherapy may play important roles in the treatment of MM. In this lecture, current standard of care and future perspectives for transplant eligible MM in Japan will be discussed.
- |||||||||| Next-Generation Novel Therapies in Multiple Myeloma (Room D (1F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_137;
A wealth of therapeutic options have been approved for the treatment of newly diagnosed (ND) and relapsed/refractory (RR) multiple myeloma (MM) over the past two decades, with proteasome inhibitors (bortezomib, carfilzomib, ixazomib), immunomodulatory drugs (IMiDs; thalidomide, lenalidomide, pomalidomide), and monoclonal antibodies (mAbs; including the CD38 mAbs daratumumab and isatuximab, as well as the SLAMF7-targeting mAb elotuzumab) currently forming the backbone of treatment approaches in each setting. Additional targeted therapies have further enhanced the armamentarium, including, previously, the histone deacetylase inhibitor panobinostat, and, more recently, the nuclear export inhibitor selinexor 1 and the peptide
- |||||||||| Truxima (rituximab-abbs) / Indukern, Teva, Mundipharma, Celltrion, Nippon Kayaku
Efficacy and Safety of Cytokine-Induced Killer Cells Infusion Combined with TRUXIMA as Post-Remission Therapy in Old Aged High-Risk Diffuse Large B Cell Lymphoma Patients (Room D (1F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_109;
Additional targeted therapies have further enhanced the armamentarium, including, previously, the histone deacetylase inhibitor panobinostat, and, more recently, the nuclear export inhibitor selinexor 1 and the peptide Methods : In this open-label, prospective phase I/II trial, 19 patients over 65 with high-risk DLBCL achieved remission within 6 months of R-CHOP chemotherapy and were enrolled and randomized to receive Truxima
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
CAR-T Therapy in Taiwan: Outcomes and Adverse Events from a National Registry Analysis (Room D (1F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_105;
Since TFDA approval and National Health Insurance reimbursement, 29 patients received tisagenlecleucel...It highlights the need for careful monitoring of adverse events, especially CRS and ICANS. Overall Survival of Patients Receiving CAR-T Therapy by Disease Type
- |||||||||| Rituxan (rituximab) / Roche
Pure Red Cell Aplasia in Acute Myeloid Leukemia Patients after ABO Mismatched HSCT (Room A (2F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_85;
Of the 19 PRCA patients, 8 were tapered off their immunosuppressant as PRCA treatment, 7 received medical therapy (steroid, rituximab, erythropoietin-stimulating agent), and the other 4 received a booster infusion...IST taper, medical therapy or booster infusions have all been effective in treating PRCA. The impact of PRCA on transplant outcomes, including iron overload and patient quality of life, remains to be investigated.
- |||||||||| Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
Choosing a CAR for Relapsed/Refractory DLBCL: Which CAR, for Whom, and When (Room B (2F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_69;
These data support the use of CAR T-cells as the preferred 2 nd line treatment in the majority of patients with relapsed/refractory LBCL, or as 3 rd line or later treatment in patients who have not received CAR T-cell therapy in 2 nd line. Ongoing studies are evaluating moving CAR T-cells even earlier as frontline therapy in very high risk patients.
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Real-World Data of CAR-T in Refractory Lymphoma in Korea (Room A (2F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_49;
In Korea, tisagenlecleucel (Tisa-cel), a CD19-targeted CAR T-cell therapy, received approval for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and for individuals up to 25 years old with B-cell precursor acute lymphoblastic leukemia (ALL) in refractory states or undergoing second or subsequent relapses...This lecture will delve into real-world data on CAR T-cell therapy in Korea, discussing patient selection, pre-therapy management, monitoring and addressing side effects post-therapy, and the risks of failure post-CAR T-cell therapy. Additionally, I will explore clinical strategies to enhance and optimize the effectiveness of CAR T-cell therapy.
- |||||||||| Real-World Outcomes with CAR T-Cell Therapy for Lymphoid Malignancies (Room A (2F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_48;
10 Additional real-world data has supported the use of brexucabtagene autoleucel (brexu-cel) in the treatment of adults with R/R ALL with notably high ORRs and particularly favorable outcomes in patients achieving minimal residual disease (MRD) negativity...12-14 Data from multiple groups have supported the safety and effectiveness of axicabtagene ciloleucel (axi-cel), tisa-cel, and lisocabtagene maraleucel (liso-cel) in treatment of R/R LBCL in the third-line setting with efficacy outcomes similar to pivotal trials...Future efforts include better refining patient selection, toxicity management, and assessing novel approaches to optimize CAR T-cell therapeutic efficacy. Strategies are also needed to promote access to CAR T-cell therapy for those with the highest need.
- |||||||||| Strategies to Mitigate CAR T-Cell-Associated Cytokine Release Syndrome and Neurologic Toxicity (Room A (2F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_47;
I will spotlight promising data from a recent clinical trial investigating the JAK-1 inhibitor itacitinib to prevent CRS and ICANS after axi-cel treatment (Frigault et al., ASH Abstract...Lastly, I will share our experience with anakinra to prevent CRS and ICANS in patients with large B-cell lymphoma receiving the CD19 CAR T-cell product lisocabtagene maraleucel on an investigator-initiated clinical trial (Liang et al., Tandem Meeting Abstract...2023). Learning objectives: - Identify clinical and laboratory factors associated with severe CRS and ICANS - Recognize differences in the toxicity profile across distinct CAR T-cell products - Become acquainted with current toxicity prophylactic strategies
- |||||||||| Darzalex (daratumumab) / J&J
Paving the Future of AL Amyloidosis Treatment with Daratumumab-Based Treatment (Room A (2F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_34;
Special care and advanced management are required for special subgroups of patients with AL amyloidosis, such as those with advanced cardiac disease (i.e those with Mayo stage 3B disease), those failing to achieve an early very good partial or complete hematologic response, those who relapse after multiple lines of therapy, those with IgM clones etc. New anti-clonal targeted options are emerging, promising high rates of complete hematologic responses but also new challenges, requiring further optimization in patients with AL amyloidosis. In addition, agents directed against the amyloid deposits are explored to aid amyloid clearance and improve organ function, but data on their efficacy are still pending.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Korean Real-World Experience of Blinatumomab for 8 Years Regarding Predictive Factors Including Lymphocyte Kinetics for Response and Survival Outcome in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia (Room A (2F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_6;
The standard protocol consisted of pre-phase dexamethasone, first cycle blinatumomab 28-days (9mcg during initial 7d followed by 28mcg for 21d) was followed by 2-week resting period and second or more cycle of 28mcg blinatumomab for 28-days...We observed early relapse with short CR duration, PB blast prior to blinatumomab, and later-line salvage were related with poor response to blinatumomab and old age and early relapse for poor OS even after allo-HCT. Regarding absolute lymphocyte count (ALC), ALC at first day of blinatumomab was not significantly affecting the response and outcome, but we observed ALC2000/mcL at 2-weeks after blinatumomab was predictive for poor response and poor survival Conclusions : Our long-term data showed blinatumomab was effective even with low ALC before blinatumomab, but preserved ALC was related with good response and better survival outcome.
- |||||||||| Iclusig (ponatinib) / Takeda, Otsuka, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Clinical Implication and Long-term Survival Outcome of Second Allogeneic HCT in Adult Patients with Relapsed Acute Lymphoblastic Leukemia before and after the Era of Novel Immunotherapeutic Agents (Room A (2F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_2;
Nowadays, emerging novel immunotherapeutic agents like blinatumomab and inotuzumab ozogamicin (INO) have improved safe remission and accessibility to second allo-HCT...Among them, 85 achieved complete remission after salvage therapy (conventional chemotherapy until 2016 and the era of blinatumomab, INO, and ponatinib since late 2016) and followed by second allo-HCT...Conclusions : Our data suggest the long-term outcomes of second allo-HCT is comparable to recent CAR-T outcomes in both Ph-positive and Ph-negative ALL, but the improvements are more evident in Ph-negative ALL with novel immunotherapeutic agents. The influence of the quality of salvage response on second allo-HCT outcome remains uncertain.Figure1.
- |||||||||| Rituxan (rituximab) / Roche
Journal: The current landscape of frontline large B-cell lymphoma trials. (Pubmed Central) - Sep 24, 2024
R-CHOP has remained the standard of care for 20 years despite dozens of trials aiming to improve upon this regimen, and only recently has a novel regimen (Pola-R-CHP) challenged its supremacy...While this variety of approaches provides a welcome increase in the overall likelihood of success, it will also present challenges if several of these trials are successful and we must choose among multiple potential treatment options that were not all tested in the same fashion. In this review, we summarize the main ongoing frontline randomized trials and discuss some of the questions that we will face in interpreting and applying their results in clinical practice in the next few years.
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis, Tecartus (brexucabtagene autoleucel) / Gilead
Journal, CAR T-Cell Therapy: The present and future for CAR-T cell therapy in adult B-cell ALL. (Pubmed Central) - Sep 24, 2024
Advancements in CAR-T design beyond CD19 represent an ongoing therapeutic evolution. Overall, CAR-T therapy signifies a paradigm shift in B-ALL management, with the potential for improved remission and survival in a historically challenging patient population.
- |||||||||| azacitidine / Generic mfg.
Trial primary completion date: PD-1 Inhibitor, Azacitidine and Low-dose DLI in AML Relapse After Allo-HSCT (clinicaltrials.gov) - Sep 24, 2024
P=N/A, N=43, Recruiting,
Overall, CAR-T therapy signifies a paradigm shift in B-ALL management, with the potential for improved remission and survival in a historically challenging patient population. Trial primary completion date: Jul 2024 --> Jul 2025
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD)
Shaping the immune landscape - Role of neo(adjuvant) checkpoint inhibition in recurrent glioblastoma (Hall 5) - Sep 24, 2024 - Abstract #EANO2024EANO_656;
Neoadjuvant checkpoint inhibition is well tolerated and associated with distinct changes to tumor transcriptome and immune milieu leading to prolonged overall survival. These findings suggest that the neoadjuvant administration of PD-1 blockade enhances the local and systemic anti-tumor immune response and may represent a more efficient approach to the salvage treatment of this uniformly lethal tumor.
- |||||||||| Opdivo (nivolumab) / BMS
Case Report: Clear Cell Carcinoma Kidney Cancer with Brain Metastasis Treated with Ketogenic Metabolic Therapy (Hall 5) - Sep 24, 2024 - Abstract #EANO2024EANO_208;
In 2019 the patient presented a pulmonary new lesion, with confirmation of clear cell carcinoma, and was treated with pazopanib due to poor tolerance to sunitinib...We started treatment with nivolumab in September 2022... This case supports the use of KMT in clear cell renal carcinoma scenarios, in which it can be associated with a synergistic effect to ITK and/or immunotherapy, as well as radiotherapy modalities, improving progression-free survival and functional improvement without increasing toxicity.
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