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  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Donor Lymphocyte Infusions in Acute Lymphoblastic Leukemia: A Single-Center Retrospective Analysis () -  Dec 7, 2024 - Abstract #ASH2024ASH_9420;    
    All but 2 patients have received an in vivo T cell depletion either with ATG, or post-transplant cyclophosphamide (for MMUD and HAPLO)...They received a median of 4 DLIs (1-12); DLIs were given in association with TKI in Ph+ ALL patients, with blinatumomab in 1 Ph- ALL case, with nelarabine in 1 T-ALL patient and with off-label bortezomib in 1 T-ALL patient...They received a median of 3 DLIs (2-4), given with TKI in Ph+ B-ALL, inotuzumab in Ph- ALL and radiotherapy in T-ALL...DLI can be an active and safe treatment for ALL, especially if used in the prophylactic/pre-emptive setting and in combination with other therapies. Better evaluation of DLI efficacy in prospective clinical trials is needed in the era of MRD monitoring and novel agents.
  • ||||||||||  melphalan / Generic mfg., fludarabine IV / Generic mfg., thiotepa / Generic mfg.
    Fludarabine-Melphalan with Total Body Irradiation or with Thiotepa Conditioning for Adult Patients with Acute Lymphoblastic Leukemia Receiving Allogeneic Stem Cell Transplantation () -  Dec 7, 2024 - Abstract #ASH2024ASH_9333;    
    2016).This study aims to retrospectively evaluate transplant outcomes of patients with ALL who received conditioning with FMT or FMTT and post-transplant cyclophosphamide (PTCy)-based GVHD prophylaxis at our institution.Methods : All adult patients (>18-year-old) with ALL who underwent AHSCT between 05/2020-05/2024 were included...GVHD prophylaxis comprised of PTCy 50 mg/kg on days +3 and +4, tacrolimus (target trough level 6-10 ng/mL) which was continued for at least 6 months as well as mycophenolate mofetil (MMF) 15 mg/kg (capped at 1,000 mg) TID, and budesonide 3 mg TID starting on day +5 which was continued until day +90, if no symptoms of acute GVHD.Results : A total of 29 patients with a median age of 44 years (range, 22-72) were included...Eleven patients (38%) with high-risk features received maintenance blinatumomab every 3 months x 4 and 5 patients (17%) with Ph+ B-cell ALL received both blinatumomab and tyrosine kinase inhibitor (ponatinib)...Patients with history of CNS disease who achieved disease control prior to transplant have excellent outcomes with FMTT conditioning, CSI pre- and 6 doses of monthly IT chemotherapy post-transplant. Outcomes with Blinatumomab +/- TKI maintenance were highly encouraging in high-risk B-cell ALL patients and may be considered for those with high-risk features.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Transformative Outcomes with Short-Term Blinatumomab and Cord Blood Transplantation in Relapsed/Refractory B-Cell ALL () -  Dec 7, 2024 - Abstract #ASH2024ASH_9330;    
    For patients who received CBT in non-CR, the probability of OS and PFS were lower compared to patients in CR (2-year OS, CR vs. non-CR, 82.6% vs. 50.0%, p = 0.025; 2-year PFS, CR vs. non-CR, 73.1% vs. 41.7%, p = 0.006).[Discussion] Short-term use of blinatumomab before CBT for R/R B-ALL was safe and effective. Our data indicate that the combination of short-term blinatumomab and CBT could become a formidable treatment option for overcoming R/R B-ALL.
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis
    Optimization of Tisagenlecleucel-Associated-Pancytopenia in a Transfusion-Free Medicine Patient with Diffuse Large B-Cell Lymphoma () -  Dec 7, 2024 - Abstract #ASH2024ASH_9272;    
    Treatment then followed with bendamustine and abdominal radiation which resulted in partial response, and subsequent epcoritimab without significant response...Following leukapheresis, she underwent bridging therapy with 1C of rituximab/polatuzumab throughout which her blood counts remained stable...For closer monitoring, she was hospitalized for lymphodepleting chemotherapy (LDc) with brentuximab and Tisa-cel reinfusion...She was briefly treated with broad spectrum antibiotics, sulfamethoxazole-trimethoprim and levofloxacin prophylaxis, 300mcg of filgrastim for 5 days, and 11 days of aminocaproic acid...Her course was also complicated by cytomegalovirus (CMV) gastritis and esophageal candidiasis treated with fluconazole and ganciclovir...CAR-T treatment modifications may also include stem cell boosts to encourage hematopoiesis for persistently profound cytopenias, and tailoring lines of chemotherapy as to avoid LDc-specific agents prior to CAR-T to maintain tumor-sensitivity. Our single-center experience at the CTFM supports the safety of CAR-T in bloodless medicine patients with DLBCL.
  • ||||||||||  Orencia (abatacept) / BMS, Blincyto (blinatumomab) / Astellas, Amgen, Actemra IV (tocilizumab) / Roche, JW Pharma
    Donor-Derived CAR-T Cells in Children with B-Lineage Acute Lymphoblastic Leukemia Relapsing after Allogeneic Hematopoietic Stem Cell Transplantation: Report of 20 Cases () -  Dec 7, 2024 - Abstract #ASH2024ASH_9247;    
    Eighteen patients had BCPALL, 2 had B cell lymphoblastic Lymphoma with BM involvement, all relapsing after multiple lines of treatment, including previous HSCT(n=20), blinatumomab (n=17), inotozumab (n=4) and CAR-T cell infusion(n=5)...Lymphodepletion included fludarabine, cyclophosphamide +/- cytarabine, 8 pts received prophylactic tocilizumab at day-1, 12 pts received abatacept at days -1, +7, +14, +28Results : Cytokine release syndrome (CRS) occurred in 15 (75%) patients and was grade ?3; all pts were treated with tocilizumab with good effect...Median time of follow-up for survivors was 1 years (range, 0,2 - 4,6).Conclusions : Our early experience suggests that donor-derived lymphoid antigen-directed CAR-T cells expand in vivo and provide CR with manageable safety profile. Prospective testing and further research of the approach is warranted.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Efficacy and Prognosis of Blinatumomab As a Bridge Therapy for Hematopoietic Stem Cell Transplantation for B-ALL () -  Dec 7, 2024 - Abstract #ASH2024ASH_9209;    
    With a median follow-up of 11 months, 41 patients had 1-year OS and PFS of 77.9% and 76.9% , respectively, and 10 MRD positive patients had 1-year OS and PFS of 66.4% and 65.6% , respectively, the 1-year OS and PFS of 31 MRD negative patients were 82.4% and 82% , respectively. Nine patients died after transplantation, including 9 from severe infection, 2 from GVHD and 3 from relapse.Result : Bridging transplantation after 7 days of continuous use of Blinatumoma has been shown to improve remission rates and long-term survival in patients with B-ALL, particularly in MRD-negative patients.
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen, Tecartus (brexucabtagene autoleucel) / Gilead
    Prognostic Impact of CD19 Status Pre-Lymphodepletion in Anti-CD19 CAR-T Therapy for B-Acute Lymphoblastic Leukemia () -  Dec 7, 2024 - Abstract #ASH2024ASH_9182;    
    Two products have been approved by the FDA include tisagenlecleucel (Tisa-cel) in August 2017 and brexucabtagene autoleucel ( Brexu-cel) in October 2021 for relapsed or refractory B-ALL...All patients received lymphodepletion (LD) therapy with fludarabine and cyclophosphamide...No significant differences were observed between the two groups in baseline characteristics such as age, CNS involvement, prior blinatumumab use, disease status, or pre-LD LDH levels, though more prior SCTs were noted in the CD19+ group (76.9% vs. 33.3%; p=0.05).For CD19-CAR-T outcomes, remission rates were 77.3% at day 30 and 72.7% at day 90...Progression-free survival (PFS) analysis showed an overall mean survival time for disease progression events of 28.8 months (95% CI = 21.4-36.3), with 26.7 months (95% CI = 17.3-36.1) for the CD19+ group and 32.5 months (95% CI = 22.7-42.4) for the CD19- group, also not statistically significant (p=0.47).Conclusions : Pre-CAR-T CD19 lymphocyte status can predict remission outcomes following CAR-T therapy. Monitoring CD19 dynamics throughout CAR-T treatment may have implications for disease management and subsequent therapeutic decisions in B-ALL patients.
  • ||||||||||  plerixafor / Generic mfg.
    Effectiveness of Single-Dose Plerixafor in Enhancing Peripheral Blood Progenitor Cell Yield and Rate of Second Collection in Autologous Transplant () -  Dec 7, 2024 - Abstract #ASH2024ASH_9148;    
    The total CD34+ cell yield across single or multiple aphereses in patients who received plerixafor had a significantly higher median cell yield (5.4 x106 cel/kg, IQR 3.4 - 8.5) than those that did not (4.2 x106 cel/kg, IQR 2.4 - 6.9) (p= 0.02). Of the first-time apheresis sessions, those in which plerixafor was used required significantly less subsequent aphereses (9/131, 6.9%) than the group that did not use plerixafor (11/70, 15.7%) (p= 0.04).ConclusionBased on our results, single dose plerixafor seems to be effective in improving the CD34+ cell yield and reducing the need for subsequent apheresis sessions in patients with poor mobilization prior to ASCT.
  • ||||||||||  Neupogen (filgrastim) / Kyowa Kirin, Amgen
    Efficiency and Safety of Pegylated Filgrastim Combined with Plerixafor in Multiple Myeloma Autologous Hematopoietic Stem Cells Mobilization () -  Dec 7, 2024 - Abstract #ASH2024ASH_9147;    
    There was also a higher tendency in Pegylated Filgrastim + Plerixafor group compared to Filgrastim + Plerixafor group (280 versus 216, p=0.123), which suggested Pegylated Filgrastim might increase the volume of collection (Supplement 3). Moreover, we collate the WBC count and CD34+ cell proportion in blood after G-CSF usage, and there is higher WBC count in blood after Pegylated Filgrastim usage (40.7 vs 22.1, p=0.002) and no statistically significant difference in CD34+ cell proportion.Adverse events of mobilizing agent were mild and controllable, mainly occured in patients with Plerixafor.Patient satisfaction survey showed MM patients(84.7%) preferred Pegylated Filgrastim mobilization regimen, and social economy benefit analysis showed Pegylated Filgrastim + Plerixafor mobilization regimen was more economic.ConclusionCompared with Filgrastim + Plerixafor, Pegylated Filgrastim + Plerixafor is more efficient, economic and patient-friendly in mobilization.Key wordsMultiple Myeloma,Autologous Hematopoietic Stem Cell Transplantation,mobilization,G-CSF,CXCR4 antagonist.
  • ||||||||||  Neupogen (filgrastim) / Kyowa Kirin, Amgen, Rituxan (rituximab) / Roche
    Early Morbimortality in Autologous Stem Cell Transplants Conducted on an Outpatient Basis in Persons with Autoimmune Disease: Experience in 1674 Patients () -  Dec 7, 2024 - Abstract #ASH2024ASH_9138;    
    P=N/A
    Prophylactic treatment with oral cotrimoxazole, acyclovir, and itraconazole was also administered...126 persons (7.5%) developed neutropenic fever for more than 48 hours; in all instances, an oral quinolone was added to the prophylactic treatment, and 40 patients were admitted to the hospital to receive intravenous meropenem provided the quinolone did not resolve the fever...Over time, these figures have decreased in our program, most likely reflecting a learning curve effect. Additional studies are needed to further analyze the safety of aHSCT when managing persons with autoimmune disease.
  • ||||||||||  Prolia (denosumab) / Amgen, Darzalex (daratumumab) / J&J
    Factors Associated with Elevation of Alkaline Phosphatase after First-Line Chemotherapy in Newly Diagnosed Multiple Myeloma By Japan Medical Data Center Claim Database () -  Dec 7, 2024 - Abstract #ASH2024ASH_8950;    
    Logistic analysis revealed that pre-treatment hemoglobin (odds ratio [OR] : 0.849, 95% confidence interval [CI] : 0.754-0.955, per 1g/dL increase; p=0.0066) and corrected Ca concentration (OR : 1.220, 95% CI : 1.030-1.440, per 1mg/dL increase; p =0.0228) were significantly associated with ALP increase. Furthermore, administration of zoledronic acid (OR : 1.580, 95% CI : 1.120-2.220; p=0.0087) and achieving a very good partial response (VGPR) within 6 months (OR : 2.010, 95% CI : 1.180-3.420; p=0.0103) were identified as treatment factors in ALP increase.Conclusion : The study suggests that addressing factors contributing to anemia may be crucial in inducing bone formation in addition to rapid reduction of MM burden and bone resorption.
  • ||||||||||  Columvi (glofitamab-gxbm) / Roche
    Rapid Step-up Dosing Schedule of Glofitamab Is Feasible for Relapsed/Refractory Diffuse Large B Cell Lymphoma Patients () -  Dec 7, 2024 - Abstract #ASH2024ASH_8583;    
    At Day 28 of Cycle 1, efficacy was evaluated using PET-CT or CT scan, and three patients responded to glofitamab (two with partial remission, and one with complete remission), and the other three patients got disease progression.Conclusions : Glofitamab given with a rapid step-up dosing schedule was tolerable in patients with relapsed/refractory DLBCL, and should be used with caution in patients with CNS lymphoma. The efficacy and safety profiles of this rapid step-up schedule needs to be verified in prospective clinical trials.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    A Study on the Relationship between Ex Vivo Drug Sensitivity and Clinical Outcome of Acute Lymphoblastic Leukemia () -  Dec 7, 2024 - Abstract #ASH2024ASH_8182;    
    Smaller values of IC50, AUC, and Emax correspond to high drug sensitivities.After sample acquisition, all patients received one of the following therapies : Modified hyper-CVAD (cyclophosphamide, vincristine, doxorubicin, dexamethasone, n=6) plus tyrosine kinase inhibitors (n=8) or L-asparaginase (n=2), inotuzumab ozogamicin (n=3), tyrosine kinase inhibitor (TKI) alone (n=3), blinatumomab (n=2), chimeric antigen receptor T-cells (CAR-T, n=1), and others (n=2)...Upon evaluating the predictive utility of the drug sensitivity metrics, we found that the Emax of cyclophosphamide or other alkylating agents (melphalan, busulfan or ifosfamide) was effective (ROC-AUC of 1.00, n=6) in predicting early disease-progression (<3 months) of Ph+ ALL...For T-ALL, the Emax of multiple drugs-decitabine, alkylating agents including cyclophosphamide, and mitoxantrone-were effective in predicting early disease progression (ROC-AUC of 1.00, n=2)...DS analysis results of single drugs were able to prediction clinical outcome of modified hyper-CVAD +/- imatinib/L-asparaginase, which consists of at least four chemotherapeutic agents. Emax, which correlates to the proportion of the drug-resistant cancer cells, was the most useful in discriminating early disease progression, coinciding with our previous observation in AML.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Outcomes of BCR::ABL1-like B-Lineage Acute Lymphoblastic Leukemia in the Era of Novel Therapies () -  Dec 7, 2024 - Abstract #ASH2024ASH_7998;    
    The remaining 20% of patients received novel therapies in first-line setting, including C10403 + inotuzumab ozogamicin (InO) in 7%, ino + blinatumomab (blin) in 6%, hyperCVD + venetoclax in 4% and C10403 + imatinib in 3%...Of note, 5 patients received tyrosine kinase inhibitors (ruxolutinib, dasatinib, imatinib) in salvage setting, but did not achieve remission...Incorporation of novel agents (InO, blin, venetoclax) in upfront chemotherapy regimens may close the gap between BCR : : ABL1-like and non-BCR : : ABL1-like disease. Future studies should focus on optimal first-line combination regimens and higher-risk subsets such as KRAS-mutated BCR : : ABL1-like B-ALL.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    A Novel Full-Spectral Flow Cytometric Assay for Detection of Measurable Residual Disease in Patients with B-Lymphoblastic Leukemia () -  Dec 7, 2024 - Abstract #ASH2024ASH_7991;    
    Cohen's Kappa test was also performed in SPSS, Kappa?0.75 indicates that the diagnostic results of two methods are in good consistency.Results : It was shown that CD19-directed therapies, such as blinatumomab and anti-CD19-CAR-T, have been receiving increasing attention in the treatment of B-ALL...There were seven samples with two inconsistent test results, and no statistical difference between the two methods by McNema's test (P=0.125). According to Cohen's Kappa test, the FSFC method has good consistency with PCR monitoring (Kappa=0.790).Conclusions : We have established a single-tube 13c-FSFC method for detecting MRD in B-ALL.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Efficacy and Tolerability of Blinatumomab in Clinical Trial Ineligible Patients with CD19+ Leukemias () -  Dec 7, 2024 - Abstract #ASH2024ASH_7983;    
    There were no BLIN-related deaths.Conclusions : BLIN was well tolerated and highly effective in patients with co-morbidities that would have precluded clinical trial enrollment. BLIN has broad survival benefits in B ALL across many disease settings and can be used in patients with co-morbid illnesses.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    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 () -  Dec 7, 2024 - Abstract #ASH2024ASH_7982;    
    Ph-negative BCP-ALL could be treated with blinatumomab from first line salvage while Ph-positive BCP-ALL after Dasatinib failure, thus at least from second line salvage. The standard protocol consisted of pre-phase dexamethasone, first cycle blinatumomab 28 days (9mcg during initial 7 days followed by 28mcg for 21 days) was followed by 2-week resting period and second or more cycle of 28mcg blinatumomab for 28 days...Regarding absolute lymphocyte count (ALC), ALC at first day of blinatumomab was not significantly associated with CR rate (OR=1.00, P=0.0523), OS (ALC?500 : 21.8% vs. ALC2000/mcL at 2-weeks after blinatumomab was predictive for poor response (OR 2.88, P=0.011), and that ALC2000/mcL at 2-weeks after blinatumomab was associated with poor survival (Figure).Conclusions : Our data shows that blinatumomab can be effective even in patients with low ALC at first day of blinatumomab, and that lesser decrease in ALC predicts higher CR in adult patients with R/R ALL.
  • ||||||||||  Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Application of Inotuzumab Ozogamicin in Children with B-ALL () -  Dec 7, 2024 - Abstract #ASH2024ASH_7967;    
    The patients were pretreated for 5 days with VAD regimen : Vindesine 3mg/m2,d1; Cytarabine 100mg/m2,d1-5; Dexamethasone 6mg/m2,d1-5 (dexamethasone can be replaced with methylprednisolone if the patient was intolerant)...Five patients were treated with InO during the induction therapy, and six were treated with InO following by the Blinatumomab consolidation therapy...However, immunoglobulin decline was associated with the risk of infection and required gamma globulin support therapy. We suggest that InO shall be increasingly applied in children with B-ALL who were initially diagnosed as high risk and MRD-positive after induction therapy.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Blinatumomab As Primary Treatment for Adult Newly Diagnosed B-ALL () -  Dec 7, 2024 - Abstract #ASH2024ASH_7964;    
    Switching to chemotherapy or oral TKI promptly after 15 days of blinatumomab treatment can considerably decrease treatment expenses and minimize complications associated with combined chemotherapy. Nevertheless, the sample size in this study is limited, necessitating further clinical evidence to validate this perspective.
  • ||||||||||  Epidaza (chidamide) / Chipscreen, Blincyto (blinatumomab) / Astellas, Amgen, Nailike (olverembatinib) / Takeda
    ABC Regimen: Combination of 3rd Generation TKI Olverembatinib, Blinatumomab and Chidamide for Older New Diagnosed Ph-Positive ALL Patients () -  Dec 7, 2024 - Abstract #ASH2024ASH_7961;    
    P2
    The analysis of overall survival (OS) showed that Blinatumomab was significantly superior over chemotherapy, with (HR 0.59, 95% CI 0.41, 0.83, P=0.003, I2=0%).Blinatumomab had a slightly higher risk of any adverse events (RR 1.05, 95% CI 1.01-1.09, P=0.01, I Previous reports showed that 3rd generation TKI ponatinib, combined with chemotherapy, result in modest rates of complete molecular response (CMR) of 75% in three months...Hence we designed an ABC regimen (NCT06220487) that combined 3rd Generation TKI Olverembatinib, Blinatumomab and Chidamide as a chemo-free regimen for new diagnosed Ph-positive ALL.MethodsFrom June 2022 to Nov 2023, 9 patients with new diagnosed Ph+ ALL treated with ABC regimen were enrolled, The detail of ABC regimen was showed in Figure 1 (Induction
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB, UCD19 CAR T Cells / University of Colorado
    Use of CD19 CAR-T Cells in Adult B-Cell Acute Lymphoblastic Leukemia (B-ALL) with Minimal Residual Disease (MRD) Positivity at First Complete Remission: Preliminary Outcomes from a Phase I Clinical Trial () -  Dec 7, 2024 - Abstract #ASH2024ASH_7956;    
    Incorporation of blinatumomab and/or inotuzumab in CR1 may mitigate the negative prognostic significance of MRD, however it is unclear if intensity of standard post-remission therapy can be safely reduced without compromising outcomes...We designed a phase I clinical trial to determine safety and tolerability of UCD19 CAR-T cell therapy for adults with B-ALL in MRD+ CR1 who are at high risk for relapse.Methods : Eligible patients include adults (?18yo) with B-ALL in CR1 after induction therapy, with MRD positivity by either flow cytometry or NGS (Clonoseq)...Longer follow-up is needed to determine if remissions remain durable, and to determine the relationship between functional persistence (as measured by B-cell aplasia) and remission durability. Enrollment is ongoing at DL2.
  • ||||||||||  Iclusig (ponatinib) / Takeda, Otsuka, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Advances in Acute Lymphoblastic Leukemia: A Longitudinal Analysis of Survival Trends and Treatment Modalities () -  Dec 7, 2024 - Abstract #ASH2024ASH_7949;    
    Despite these advances, the variable efficacy of radiation therapy and the nuanced outcomes across different patient subgroups show there are still opportunities for further research into optimizing treatment combinations. This study not only highlights historical progress over the last 5 decades but also emphasizes ongoing challenges and areas for future investigation in the treatment of ALL.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Blincyto (blinatumomab) / Astellas, Amgen, Oncaspar liquid (pegaspargase) / Servier
    Clinical Characteristics and Outcomes of Infant Acute Lymphoblastic Leukemia from a Single Institute in China () -  Dec 7, 2024 - Abstract #ASH2024ASH_7943;    
    Conclusions : IALL patients frequently have KMT2A-R and exhibit high relapse rates and poor prognosis. Considering the toxicity associated with intensive induction chemotherapy, combining reduced-intensity chemotherapy with blinatumomab may provide a more cost-effective therapeutic strategy.
  • ||||||||||  Cytokine Release Syndrome: Trends with T Cell Engaging Bispecifics from a Systematic Review of Licensing Applications () -  Dec 7, 2024 - Abstract #ASH2024ASH_7878;    
    Mosunetuzumab and elranatamab had the lowest CRS risk among TCEs for non-hodgkin's lymphoma (NHL) (range 39-70%) and multiple myeloma (MM) (range 58-79%), respectively...All TCEs employed a 2 step priming approach, except blinatumomab (1 step; continuous infusion) and talquetamab bi-weekly (3 step), and were successful at mitigating CRS beyond the first full dose...Covariates associated with CRS included baseline factors (disease status, treatment history, target level, effector cell status, age) and on-treatment factors (tocilizumab use, prior Cmax)...Thus, further characterizing CRS and establishing a link between drug levels, biomarkers, and clinical events will not only aid TCE development but also benefit patients by reducing the need for intensive clinical interventions and hospitalization. Quantitative clinical pharmacology methods including mechanism- and empirical-based approaches will continue to be instrumental in TCE development, especially as regimens become more complex with combination and pretreatment integration.
  • ||||||||||  RMC-7977 / Revolution Medicines
    Pan-RAS Inhibitor RMC-7977 Overcomes Oncogenic RAS Signaling and Exerts Antileukemic Effects in CMML/AML Cells () -  Dec 7, 2024 - Abstract #ASH2024ASH_7864;    
    Experiments evaluating the effects of RMC-7977 in cell line xenografts and additional patients' primary samples are ongoing and will be presented.Collectively, we have demonstrated that the pan-RAS inhibitor RCM-7977 is highly effective against RAS mutated CMML/AML cell lines arising from chronic myeloid neoplasms including CMML while sparing healthy hematopoietic stem and progenitor cells. This work provides the rationale to continue evaluating RAS inhibitors as a targeted therapy in RAS-mutated myeloid malignancies, which is a significant unmet need in the treatment of these conditions.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Acute Lymphoblastic Leukemia in Shwachman-Diamond Syndrome: Challenges and Treatment Outcomes () -  Dec 7, 2024 - Abstract #ASH2024ASH_7787;    
    Patient then received consolidation therapy with allogeneic-stem cell transplantation (SCT).The conditioning regimen consisted of 12 Gy- total body irradiation (TBI)plus etoposide and graft versus host disease (GVHD) prophylaxis was obtained with Cyclosporin A; no short-course methotrexate (MTX) was given in order to minimizing toxicities.In September 2021, the patient experienced a molecular relapse detected by two consecutive bone marrow evaluations...To our knowledge, our patient represents the fifth reported lymphoid malignancy in SDS who achieved a CR in a relatively short time and is the only one alive and in CR after transplantation with a follow-up exceeding three years from diagnosis.Second ALL can be very aggressive disease with poor prognosis, particularly challenging to treat in patients with SDS where treatment experience is limited. The BFM-inspired protocols emphasize the importance of dose density and intensity for achieving CR, which is difficult to obtain due to the SDS features, such as long time to bone marrow recover and the pancreatic insufficiency which did not allow the use of a crucial drug of the chemotherapy protocolBlinatumomab emerged as the optimal treatment option for low toxicity and well tolerable profile with no gastrointestinal/pancreatic side effects and low-grade hematological toxicities allowing adherence to the treatment and serving as a bridge toallogeneic-SCT performed to consolidate the CR based on the consideration that a secondary ALL is per se an high risk disease.
  • ||||||||||  Struck By Tsunami: Difficult Case of a Severe Refractory ITP () -  Dec 7, 2024 - Abstract #ASH2024ASH_7526;    
    While the majority of cases present with mild to moderate thrombocytopenia, severe cases can pose significant challenges in diagnosis and management.We present the case of a 65-year-old male with severe ITP refractory to initial standard treatment including steroids and intravenous immunoglobulin (IVIG) requiring further management including rituximab, romiplostim, Fostamatinib, romiplostim, Efgartigimoid alfa-fcab , eltrombopag and partial splenic embolization.Case presentationOur patient is a 65-year-old male with a significant medical history, including end-stage renal disease (ESRD), diffuse large B-cell lymphoma (DLBCL) status post-stem cell transplant in 2015, and chronic immune thrombocytopenic purpura (ITP)...Also during hospital stay General Surgery were consulted to assess the patient for splenectomy, which was deferred due to low platelet levels and to allow for further evaluation of the effects of embolization.Following two weeks from the second partial splenic embolization, the patient's platelet count exhibited continuous improvement, reaching a level of 25 x 10^9 /L upon discharge.Discussion : Newer therapies are in the drug class thrombopoietin receptor agonists (TPO-RAs), which include romiplostim (Nplate), eltrombopag (Promacta), and avatrombopag (Doptelet), which have all been approved by the FDA...TPO-RAs have a lower risk of side effects than older treatments, thus making them more tolerable for patients.Although newer drug therapies have shown efficacy for many patients with early stages of ITP, our case demonstrates decreasing splenic function remains an effective treatment as it removes the major site of platelet phagocytosis and autoantibody production.15 However, due to critically low platelets in the majority of these patients, splenectomy can be associated with many complications including bleeding, infection, and thrombosis. Splenic artery embolization represents an effective alternative to increase platelet counts while minimizing complications.Conclusion :