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1071 citation(s) found for "Dürr, Alexandra".

Outcomes of Primary Bone Diffuse Large B-Cell Lymphoma in the Rituximab Era: A Multicenter Retrospective Analysis
Rezazadeh, Alexandra , Monahan, Kathleen , Khurana, Arushi , Inwards, David J. , Lunning, Matthew A. , Cashen, Amanda F. , Rodgers, Thomas D. , Chowdhury, Sayan Mullick , Epperla, Narendranath , Mendries, Hiruni, Hill, Brian T. , Oh, Timothy S. , Chang, Julie , Isaac, Krista M. , Portell, Craig A. , Siker, Malika, King, David M. , Fenske, Timothy S. , Epperla, Narendranath , Portell, Craig A , Szabó, Anikó , Monahan, Kathleen, Bartlett, Nancy L. , Caimi, Paolo F. , Barr, Paul M. , Karmali, Reem , Goyal, Gaurav , Parsons, Benjamin M.

Blood | November 23, 2021 | Volume: 138 | Issue: Supplement 1 | Pages: 1451-1451

10.1182/blood-2021-145145 Get It

Abstract Background Primary bone diffuse large B cell lymphoma (DLBCL) is a variant of extranodal non-Hodgkin lymphoma (NHL) that is relatively rare, accounting for 3-15% of extranodal NHL and less than 1% of all NHL. Patients often present with pain and swelling or pathologic fracture of the affected area of the skeleton, and B symptoms are often less prevalent. Many cases are limited stage at presentation. Patients are usually treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or similar induction therapy. Based on older studies showing improved outcomes associated with the addition of radiation (many completed prior to the rituximab era), patients often still receive combined-modality therapy today. However, it remains unknown whether consolidative radiation therapy (RT) confers additional benefit following rituximab-based chemoimmunotherapy (CIT) induction. We sought to address this question in a multicenter retrospective study. Methods We conducted a retrospective analysis of outcomes in a modern cohort of patients who underwent treatment for primary bone DLBCL using chemotherapy regimens in the rituximab era either with or without consolidative RT. Data was collected from 13 academic medical centers in the U.S., with patients treated between 2005 and 2019. Patients were identified using each institution's hematologic malignancy registries. Analysis was limited to patients with primary bone DLBCL, with stage I-II disease (primary site +/- locoregional lymph nodes) that could be encompassed in a radiation field. Patients who received CIT alone or CIT followed by RT were included. Treatment selection was at the treating physician's discretion. Electronic medical records were reviewed for: demographics, chemotherapy regimens, radiation treatments, and PET scan data. Local IRB approval was obtained at sites. All data was distributed in a de-identified fashion. The primary outcomes were overall survival (OS), and relapse-free survival (RFS). Secondary outcomes included: response after induction CIT induction and the need for additional therapies. Chi-square test analysis was used to compare categorical variables and the Wilcoxon rank-sum test was used for continuous and ordinal measures. Survival curves were estimated using the Kaplan-Meier method and compared between groups via the log-rank test. Multi-variable analysis (MVA) for OS and RFS was performed using RT vs no RT, PET status post CIT (negative vs positive) and rituximab in induction (Y/N) as variables. Results A total of 127 patients were included: 91 who received CIT and radiation (RT group), and 36 who received CIT alone (no RT group). The median age of patients at diagnosis in the RT group and no RT group was 58.5 and 57.0, respectively. For CIT, the majority of patients received R-CHOP (84%). Despite focusing on 2005-2019, a small percentage of patients (5 - 14%) in each group (RT and no RT) did not receive rituximab with their induction therapy. The OS at 10 years was 74.5% in the RT group and 86.5% in the no RT group (p = 0.29). The RFS at 10 years was 70.9% in the RT group and 78.2% in the no RT group (p = 0.85). Among the 91 patients who received RT, 67 (77.0%) received a dose of 36 Gy or higher. There was no difference in OS (p = 0.63) or RFS (p = 0.90) in patients who received > 36 Gy vs < 36 Gy of radiation. On MVA for OS, RT was not associated with improved OS, although rituximab as part of induction was (p = 0.048). On MVA for RFS, neither RT nor rituximab were associated with improved RFS. For rituximab the trend was in the direction of rituximab benefit (p = 0.11). Conclusion Our results demonstrate that, in the rituximab era, patients with limited stage primary bone DLBCL have excellent outcomes overall. In this study, neither RFS or OS appeared to be improved with the addition of consolidative RT. Rituximab, however, was associated with improved OS on MVA. Outcomes do not appear to differ based on the dose of RT (> 36 Gy vs < 36 Gy). Our data suggests that RT may have less benefit for primary bone DLBCL in the rituximab era, although it is possible that a subset of patients may benefit from consolidative radiation therapy. A larger data set would likely be needed to evaluate this. We plan to present data regarding PET responses at the meeting. Figure 1 Figure 1. Disclosures Lunning: Acrotech: Consultancy; AstraZeneca: Consultancy; Myeloid Therapeutics: Consultancy; Janssen: Consultancy; Morphosys: Consultancy; Novartis: Consultancy; Karyopharm: Consultancy; Kyowa Kirin: Consultancy; Verastem: Consultancy; Kite, a Gilead Company: Consultancy; Celgene, a Bristol Myers Squibb Co.: Consultancy; Spectrum: Consultancy; Daiichi-Sankyo: Consultancy; Beigene: Consultancy; Legend: Consultancy; ADC Therapeutics: Consultancy; TG Therapeutics: Consultancy; AbbVie: Consultancy. Cashen: Secura Bio, ADC Therapeutics: Consultancy. Bartlett: Autolus: Research Funding; Bristol Myers Squibb: Research Funding; Celgene: Research Funding; Forty Seven: Research Funding; Genentech: Research Funding; Janssen: Research Funding; Kite, a Gilead Company: Research Funding; Merck: Research Funding; Millennium: Research Funding; Pharmacyclics: Research Funding; Seagen: Consultancy, Research Funding; Roche/Genentech: Consultancy; ADC Therapeutics: Consultancy, Research Funding. Caimi: XaTek: Patents & Royalties: Royalties from patents (wife); Amgen Therapeutics.: Consultancy; ADC Theraputics: Consultancy, Research Funding; Genentech: Research Funding; TG Therapeutics: Honoraria; Seattle Genetics: Consultancy; Verastem: Consultancy; Kite Pharmaceuticals: Consultancy. Rodgers: MJH Lifesciences: Consultancy. Barr: Morphosys: Consultancy; Gilead: Consultancy; Genentech: Consultancy; TG Therapeutics: Consultancy; Janssen: Consultancy; Beigene: Consultancy; Bristol Meyers Squibb: Consultancy; Seattle Genetics: Consultancy; AstraZeneca: Consultancy; Abbvie/Pharmacyclics: Consultancy. Epperla: Verastem: Speakers Bureau; Beigene: Speakers Bureau; Karyopharm: Other: Ad Board; Genzyme: Honoraria. Hill: AstraZenica: Consultancy, Honoraria; Celgene (BMS): Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Kite, a Gilead Company: Consultancy, Honoraria, Other: Travel Support, Research Funding; Pfizer: Consultancy, Honoraria; Gentenech: Consultancy, Honoraria, Research Funding; AbbVie: Consultancy, Honoraria, Research Funding; Epizyme: Consultancy, Honoraria; Incyte/Morphysis: Consultancy, Honoraria, Research Funding; Beigene: Consultancy, Honoraria, Research Funding; Karyopharm: Consultancy, Honoraria, Research Funding. Karmali: BMS/Celgene/Juno: Consultancy, Research Funding; Epizyme: Consultancy; Karyopharm: Consultancy; Janssen/Pharmacyclics: Consultancy; Morphosys: Consultancy, Speakers Bureau; AstraZeneca: Speakers Bureau; BeiGene: Consultancy, Speakers Bureau; EUSA: Consultancy; Takeda: Research Funding; Genentech: Consultancy; Roche: Consultancy; Kite, a Gilead Company: Consultancy, Research Funding, Speakers Bureau. Portell: Acerta/AstraZeneca: Research Funding; Xencor: Research Funding; Abbvie: Research Funding; Aptitude Health: Honoraria; Morphosys: Honoraria; Targeted Oncology: Honoraria; SeaGen: Research Funding; BeiGene: Honoraria, Research Funding; Merck: Honoraria, Research Funding; Pharmacyclics: Honoraria; Kite: Honoraria, Research Funding; TG Therapeutics: Honoraria, Research Funding; Genentech: Research Funding; VelosBio: Research Funding. Fenske: Pharmacyclics: Consultancy; AstraZeneca: Speakers Bureau; Servier Pharmaceuticals: Consultancy; MorphoSys: Consultancy; Adaptive Biotechnologies: Consultancy; KaryoPharm: Consultancy; CSL Therapeutics: Consultancy; TG Therapeutics: Consultancy, Speakers Bureau; Bristol-Myers Squibb: Speakers Bureau; Sanofi: Speakers Bureau; Seattle Genetics: Speakers Bureau; Biogen: Consultancy; ADC Therapeutics: Consultancy; Kite (Gilead): Speakers Bureau; Beigene: Consultancy; AbbVie: Consultancy.
High-Dose Methotrexate Is Not Associated with Reduction in CNS Relapse in Patients with Aggressive B-Cell Lymphoma: An International Retrospective Study of 2300 High-Risk Patients
Villa, Diego , Bobillo, Sabela , Smedby, Karin Ekstroem, Eyre, Toby A. , Cwynarski, Kate , Caporn, Paris L., Zyl, Joan Van, Puckrin, Robert , Stewart, Douglas A. , Thanarajasingam, Gita , Joffe, Erel , Eloranta, Sandra , Maliske, Seth , Poonsombudlert, Kittika , Guo, Xiao, Hapgood, Greg , Manos, Kate , Gilbertson, Michael , Streit, Isaac T, Scott, Hamish W , Ku, Matthew , Mel, Sanjay De , Yong, Kar Ying , Liu, Xin , Mokoonlall, Mridula , McVilly, Nicholas L., Johnston, Anna , Brunner, Matthew, Ku, Matthew , Lewis, Katharine L. , Jakobsen, Lasse Hjort , Savage, Kerry J. , Klánová, Magdalena , Trněný, Marek , Bishton, Mark , Fox, Christopher P. , Tun, Aung M. , Djebbari, Faouzi , Harrysson, Sara , Sehn, Laurie H. , Hawkes, Eliza A. , Khwaja, Jahanzaib , Minson, Adrian , Dickinson, Michael , Øvlisen, Andreas Kiesbye , Gregory, Gareth P. , Streit, Isaac T., Talaulikar, Dipti , Brunner, Matthew J, Pophali, Priyanka A. , Maurer, Matthew J. , El‐Galaly, Tarec Christoffer , Cheah, Chan Y.

Blood | November 23, 2021 | Volume: 138 | Issue: Supplement 1 | Pages: 181-181

10.1182/blood-2021-146737 Get It

Abstract Introduction Central nervous system relapse (secondary central nervous system lymphoma -SCNS) is an uncommon but devastating complication of aggressive B-cell lymphoma. Patients (Pts) with CNS-IPI 4-6 are at greatest risk (10.2% at 2 years). Intravenous high-dose methotrexate (HD-MTX) is widely used to mitigate SCNS risk but data supporting this practice are limited. Methods We performed a multicentre, retrospective study at 21 sites in Australia, Asia, North America and Europe. Chart or registry review was performed for consecutively diagnosed pts with diffuse large B-cell lymphoma (DLBCL) and CNS-IPI 4-6, high grade B-cell lymphoma (HGBL) with rearrangements of MYC+BCL2 and/or BCL6 and primary breast/testicular DLBCL irrespective of CNS-IPI. Pts were diagnosed between 2000-2020, 18-80 years at diagnosis, and treated with curative intent anti-CD20 based chemo-immunotherapy. Pts with CNS involvement at diagnosis were excluded. HD-MTX was defined as at least one cycle of intravenous MTX at any dose. Time to SCNS was calculated from date of diagnosis (all-pts), and from the end of frontline systemic lymphoma therapy, defined as 6x21 days from diagnosis (complete response (CR-pts)), until SCNS, systemic relapse, death, or censoring, whichever came first. Cumulative risk of SCNS was computed using the Aalen-Johansen estimator treating death and systemic relapses as competing events. Adjusted cumulative risks were obtained by using an inverse probability of treatment weighting approach. The average treatment effect was computed as the difference in adjusted 5-year risk of SCNS. Results - 2300 and 1455 pts were included in the all-pts and CR-pts analyses, respectively. Baseline demographics and details of therapy are summarised in Table 1. Except for a predominance of males, pts ≤60 years and pts with ECOG 0-1 in the HD-MTX vs no HD-MTX groups, the demographics and treatments were well balanced. At a median follow up of 5.9 years (range 0.0-19.1) and 5.5 years from diagnosis (range 0.0-18.7), 201/2300 and 84/1455 pts experienced CNS events in the all-pts and CR-pts analyses respectively. For all-pts(n=2300), CNS-IPI was 4-6 in 2052(89.2%), with R-CHOP-like therapy given to 93.8%. 410 pts (17.8%) received HD-MTX (265 HD-MTX alone, 145 in combination with intrathecal methotrexate (IT-MTX);435 received IT-MTX alone;1455 received neither. There were 32/410 and 169/1890 SCNS events, with median time from diagnosis to SCNS of 8.8 and 6.7 months in the HD-MTX and no HD-MTX groups respectively. 5-year OS was 70% (95% CI, 65-76%) and 55% (95% CI 53-57%) in HD-MTX and no HD-MTX groups respectively. There was no difference in the adjusted 5-year risk of SCNS between the HD-MTX and no HD-MTX groups (8.4% vs 9.1%, adjusted hazard ratio [HR] 0.71, p=0.100) (Figure 1). For CR-pts(n=1455), CNS-IPI was 4-6 in 1267(87.0%), with R-CHOP-like therapy given to 93.3%. 284 pts (19.5%) received HD-MTX (170 HD-MTX alone, 114 with IT-MTX);298 received IT-MTX alone;873 received neither. There were 16/284 and 68/1171 SCNS events, with median time from diagnosis to SCNS of 11.0 and 10.3 months in the HD-MTX and no HD-MTX groups respectively. 5-year OS was 74%(95% CI 67-81%) and 75%(95% CI 72-78%) in the HD-MTX groups and no HD-MTX groups respectively (adjusted HR 1.08, p=0.622). There was no difference in the 5-year risk of CNS relapse between the HD-MTX and no HD-MTX groups 5.0% vs 6.0% (adjusted HR 1.03, p=0.903) (Figure 2). Exploratory analysis of the impact of HD-MTX among the highest risk groups CNS IPI 5 (n=368), CNS-IPI 6 (n=59) and CNS-IPI 6 plus all pts with testicular, renal or adrenal involvement (n=349) did not reveal differences in SCNS rates in HD-MTX treated pts. Additional subgroup analyses will be presented at the meeting. Conclusions To our knowledge, this is the largest study of the efficacy of HD-MTX in reducing SCNS events focusing exclusively on high-risk pts. The overall incidence of CNS relapse observed was consistent with previous reports in similar patient cohorts at 9%. The use of HD-MTX did not lower SCNS rates overall or when analysis was confined to CR pts at completion of curative intent therapy to compensate for potential immortal bias associated with HD-MTX therapy. Despite the limitations of the non-randomized and retrospective design, it appears unlikely that HD-MTX is associated with a clinically meaningful reduction in SCNS rates in pts with high risk for SCNS. Figure 1 Figure 1. Disclosures Lewis: AstraZeneca: Consultancy, Honoraria; Novartis: Patents & Royalties: Conference attendance; Janssen: Honoraria, Patents & Royalties: Conference attendance; Roche: Consultancy, Honoraria. Villa: Janssen: Honoraria; Gilead: Honoraria; AstraZeneca: Honoraria; AbbVie: Honoraria; Seattle Genetics: Honoraria; Celgene: Honoraria; Lundbeck: Honoraria; Roche: Honoraria; NanoString Technologies: Honoraria. Bobillo: F. Hoffmann-La Roche Ltd: Consultancy, Speakers Bureau; Gilead: Speakers Bureau. Ekstroem Smedby: Takeda: Consultancy; Janssen Cilag: Research Funding. Savage: Merck: Consultancy, Honoraria, Other: Institutional clinical trial funding; BMS: Consultancy, Honoraria, Other: Institutional clinical trial funding; AbbVie: Consultancy, Honoraria; Roche: Research Funding; Takeda: Other: Institutional clinical trial funding; Servier: Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria; Astra-Zeneca: Consultancy, Honoraria; Beigene: Other: Institutional clinical trial funding; Genentech: Research Funding. Eyre: Beigene: Honoraria, Research Funding; Incyte: Consultancy; Secura Bio: Consultancy, Honoraria; Janssen: Honoraria; Gilead/KITE: Honoraria, Other: Travel support for conferences, Research Funding, Speakers Bureau; Loxo Oncology: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Consultancy, Honoraria, Other: Travel to conferences; AstraZeneca: Honoraria, Research Funding; Roche: Consultancy, Honoraria. Cwynarski: Incyte: Consultancy, Speakers Bureau; Gilead: Consultancy, Speakers Bureau; Atara: Consultancy; Celgene: Consultancy; Takeda: Consultancy, Other: travel to scientific conferences, Speakers Bureau; Kite, a Gilead Company: Consultancy, Other: travel to scientific conferences, Speakers Bureau; Janssen: Consultancy, Other: travel to scientific conferences; Roche: Consultancy, Other: travel to scientific conferences, Speakers Bureau; BMS/Celgene: Other: travel to scientific conferences. Stewart: Teva: Honoraria; Sandoz: Honoraria; Amgen: Honoraria; AstraZeneca: Honoraria; Novartis: Honoraria; Celgene: Honoraria; Gilead: Honoraria; Abbvie: Honoraria; Janssen: Honoraria; Roche: Honoraria. Bishton: Gilead: Honoraria, Other: Travel grants; AbbVie: Honoraria, Other: Travel grants; Celgene/BMS: Honoraria, Other: travel grants; Celltrion: Honoraria, Other: Travel grants; Takeda.: Honoraria, Other: Travel grants . Fox: F. Hoffmann-La Roche Ltd: Consultancy, Membership on an entity's Board of Directors or advisory committees. Joffe: Epizyme: Consultancy; AstraZeneca: Consultancy. Eloranta: Janssen Pharmaceutical NV: Other: NV. Sehn: Genmab: Consultancy; Novartis: Consultancy; Debiopharm: Consultancy. Manos: Bristol-Myers Squibb: Other: Travel and meetings. Hawkes: Specialised Therapeutics: Consultancy; Gilead: Membership on an entity's Board of Directors or advisory committees; Merck Sharpe Dohme: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Antigene: Membership on an entity's Board of Directors or advisory committees; Regeneron: Speakers Bureau; Bristol Myers Squib/Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Merck KgA: Research Funding; Astra Zeneca: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Roche: Membership on an entity's Board of Directors or advisory committees, Other: Travel and accommodation expenses, Research Funding, Speakers Bureau; Janssen: Speakers Bureau. Minson: Novartis: Research Funding; Hoffman La Roche: Research Funding. Dickinson: Celgene: Research Funding; Amgen: Honoraria; Takeda: Research Funding; Gilead Sciences: Consultancy, Honoraria, Speakers Bureau; MSD: Consultancy, Honoraria, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria; Roche: Consultancy, Honoraria, Other: travel, accommodation, expenses, Research Funding, Speakers Bureau; Novartis: Consultancy, Honoraria, Research Funding, Speakers Bureau. Øvlisen: Abbvie: Other: Travel expenses. Gregory: Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel fees, Speakers Bureau; Janssen: Consultancy; Novartis: Consultancy. Ku: Roche: Consultancy; Antegene: Consultancy; Genor Biopharma: Consultancy. Talaulikar: Roche: Honoraria, Research Funding; Jansenn: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Takeda: Honoraria, Research Funding; EUSA Pharma: Honoraria, Research Funding. Maurer: Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Research Funding; Genentech: Research Funding; Kite Pharma: Membership on an entity's Board of Directors or advisory committees; Morphosys: Membership on an entity's Board of Directors or advisory committees, Research Funding; Nanostring: Research Funding. El-Galaly: Abbvie: Other: Speakers fee; ROCHE Ltd: Ended employment in the past 24 months. Cheah: Roche: Consultancy, Honoraria, Other: advisory and travel expenses, Research Funding; Janssen: Consultancy, Honoraria, Other: advisory; MSD: Consultancy, Honoraria, Other: advisory, Research Funding; Gilead: Consultancy, Honoraria, Other: advisory; Ascentage pharma: Consultancy, Honoraria, Other: advisory; Beigene: Consultancy, Honoraria, Other: advisory; AbbVie: Research Funding; Celgene: Research Funding; AstraZeneca: Consultancy, Honoraria, Other: advisory; Loxo/Lilly: Consultancy, Honoraria, Other: advisory; TG Therapeutics: Consultancy, Honoraria, Other: advisory.
A Phase 1 Study of XmAb18968, a CD3-CD38 Bispecific Antibody for the Treatment of Patients with Relapsed/Refractory Acute Leukemia and T Cell Lymphoblastic Lymphoma
Kearl, Tyce , Johnson, Bryon D. , Harrington, Alexandra M., Carlson, Karen, Michaelis, Laura C. , Runaas, Lyndsey, Abedin, Sameem , Pratz, Keith W. , Luger, Selina M. , Baim, Arielle , Yaghoubi, Shahriar, Abedin, Sameem , Murthy, Guru Subramanian Guru , Cui, Weiguo , Hoffmeister, Karin M. , Szabó, Anikó , Aoki, Kazuhiro , DuVall, Adam , Stock, Wendy , Shah, Bijal , Leonard, Jessica T , Badar, Talha , Atallah, Ehab

Blood | November 23, 2021 | Volume: 138 | Issue: Supplement 1 | Pages: 4401-4401

10.1182/blood-2021-149329 Get It

Abstract Background: Outcomes of adults with relapsed/refractory T-cell acute lymphoblastic leukemia or lymphoma (T-ALL or T-LBL respectively) and acute myeloid leukemia (AML) have remained poor despite the availability of newer agents. CD38 is a 45 kDa transmembrane glycoprotein expressed by lymphoid and myeloid cells with several important functions including a role in immune escape from tumor cells [Chillemi A et al. Front Immunol 2017, Furano A et al. J Immunol 1990]. Several studies have demonstrated that CD38 is expressed in tumor cells of patients with T-ALL and AML and potentially targetable using CD38 blocking agents [Naik J et al. Haematologica 2019, Bride KL et al. Blood 2018, Tembhare et al. J Immunother Cancer 2020, Farber M et al. ASH 2018]. XmAb18968 is structurally distinct CD3-CD38 bi-specific T-cell engager with a full fragment crystallizable (Fc) domain modified to minimize Fcγ receptor binding and non-selective activation of T cells and other immune effector cells. XmAb18968 has optimized relative affinities for both CD3 and CD38 which results in reduced cytokine release without compromising target cell killing. We hypothesize targeting CD38 in relapsed/refractory- T-cell ALL/LBL and AML is safe and feasible using XmAb18968, a novel CD3-CD38 bispecific antibody. Study design and methods: This is an investigator-sponsored multi-institutional phase I study evaluating the safety and tolerability of XmAb18968. Patients aged 18 years or above with T-ALL, T-LBL or AML (including undifferentiated leukemia and bi phenotypic leukemia), in relapsed/refractory status (at least one line of prior therapy) including measurable residual disease relapse, CD38 expression ≥ 20%, and adequate organ function will be eligible. Major exclusion criteria are hematopoietic cell transplantation (HCT) within 6 months of enrollment, active acute GVHD, veno-occlusive disease, and acute promyelocytic leukemia. The study is planned to be conducted at 6 sites in United States. The primary endpoint is to determine the recommended phase 2 dose (RP2D) and toxicity profile of XmAb18968. The secondary endpoints include determination of response rates, duration of response, survival and pharmacokinetics. Exploratory endpoints include correlation of responses with genomic profile, assessment of serum cytokine response, identifying the changes in phenotypic expression of activated T-cells and leukemic cells, correlation of the phenotypic expression with changes in the transcriptome at the single-cell level, proteomics evaluation of cytokine secretion at the single-cell level and correlation of response with N-glycan profiling, quantitative site-occupancy and direct glycopeptide analysis. The study will follow 3+3 design for dose escalation and de-escalation in case of dose limiting toxicity (DLT). Dose escalation will proceed in two separate groups: Group A for subjects with T-ALL and T-LBL and Group B for subjects with AML. Patients will be entered sequentially to each dose level, starting with the first dose level. The DLT observation period for dose-escalation will be 28-days. RP2D will be defined as the highest dose level at which none of the first 3 treated subjects, or no more than 1 of the first 6 treated subjects experience a DLT. A minimum of 24 and a maximum of 60 patients will be needed for the dose escalation phase. Disclosures Guru Murthy: Curio Sciences: Honoraria; Techspert: Consultancy; Qessential: Honoraria; CancerExpertNow: Honoraria; DAVA Oncology: Honoraria; TG Therapeutics: Other: Advisory board meeting; Cardinal health: Honoraria; Guidepoint: Consultancy. Johnson: Miltenyi Biotec: Research Funding. Abedin: AltruBio: Research Funding; Amgen: Honoraria; Agios: Honoraria; Helsinn: Research Funding; Pfizer: Research Funding; Astellas Pharma Inc.: Research Funding; Actinium: Research Funding. Stock: Pfizer: Consultancy, Honoraria, Research Funding; amgen: Honoraria; agios: Honoraria; jazz: Honoraria; kura: Honoraria; kite: Honoraria; morphosys: Honoraria; servier: Honoraria; syndax: Consultancy, Honoraria; Pluristeem: Consultancy, Honoraria. Shah: Precision Biosciences: Consultancy; Kite, a Gilead Company: Consultancy, Honoraria, Other: Expenses, Research Funding; Pharmacyclics/Janssen: Honoraria, Other: Expenses; Acrotech/Spectrum: Honoraria; BeiGene: Consultancy, Honoraria; Amgen: Consultancy; Pfizer: Consultancy, Other: Expenses; Novartis: Consultancy, Other: Expenses; Bristol-Myers Squibb/Celgene: Consultancy, Other: Expenses; Adaptive Biotechnologies: Consultancy; Servier Genetics: Other; Jazz Pharmaceuticals: Research Funding; Incyte: Research Funding. Leonard: Amgen: Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees. Pratz: Agios: Consultancy; BMS: Consultancy, Honoraria; Novartis: Consultancy; Astellas: Consultancy, Honoraria, Research Funding; Cellgene: Consultancy, Honoraria; Millenium: Research Funding; University of Pennsylvania: Current Employment; Abbvie: Consultancy, Honoraria, Research Funding. Luger: Syros: Honoraria; Agios: Honoraria; Daiichi Sankyo: Honoraria; Jazz Pharmaceuticals: Honoraria; Brystol Myers Squibb: Honoraria; Acceleron: Honoraria; Astellas: Honoraria; Pfizer: Honoraria; Onconova: Research Funding; Celgene: Research Funding; Biosight: Research Funding; Hoffman LaRoche: Research Funding; Kura: Research Funding. Badar: Pfizer Hematology-Oncology: Membership on an entity's Board of Directors or advisory committees. Atallah: Novartis: Consultancy, Honoraria, Research Funding; Amgen: Consultancy; Abbvie: Consultancy, Speakers Bureau; Takeda: Consultancy, Research Funding; BMS: Honoraria, Speakers Bureau; Pfizer: Consultancy, Research Funding.
Histiocytic Neoplasms, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology
Jacobsen, Eric D. , Baiocchi, Robert A. , Buhtoiarov, Ilia N. , Butler, Erin , Goodman, Aaron M. , Gratzinger, Dita , Higman, Meghan A., Hogarty, Michael D. , Jankú, Filip , Raldow, Anne C., Stefanovic, Alexandra, Tantravahi, Srinivas K. , Walkovich, Kelly, Bergman, Mary Anne, Darlow, Susan, Go, Ronald S. , Butler, Erin B. , Campbell, Patrick , Coulter, Donald W. , Diamond, Eli L. , Flagg, Aron , Goyal, Gaurav , Hendrie, Paul C. , Karmali, Reem , Morgan, David , Raldow, Ann C. , Zhang, Ling

Journal of the National Comprehensive Cancer Network | November 15, 2021 | Volume: 19 | Issue: 11 | Pages: 1277-1303

10.6004/jnccn.2021.0053 | PMID 34781268 Get It

Histiocytic neoplasms are rare hematologic disorders accounting for less than 1% of cancers of the soft tissue and lymph nodes. Clinical presentation and prognosis of these disorders can be highly variable, leading to challenges for diagnosis and optimal management of these patients. Treatment often consists of systemic therapy, and recent studies support use of targeted therapies for patients with these disorders. Observation (“watch and wait”) may be sufficient for select patients with mild disease. These NCCN Guidelines for Histiocytic Neoplasms include recommendations for diagnosis and treatment of adults with the most common histiocytic disorders: Langerhans cell histiocytosis, Erdheim-Chester disease, and Rosai-Dorfman disease.
509 A first-in-human phase 1 study of NL-201 in patients with relapsed or refractory cancer
Callahan, Margaret K. , Costello, Brian A. , Curti, Brendan D. , Hansen, Aaron R. , Long, Georgina V. , Shankles, Brooke, Ulge, Umut Y. , Weickhardt, Andrew , Long, Georgina V , Hansen, Aaron R , Naing, Aung , Hall, Evan , Joshua, Anthony M.

Regular and Young Investigator Award Abstracts | November 9, 2021 | Volume: No volume available | Issue: No issue available | Pages: A540-A540

10.1136/jitc-2021-sitc2021.509 Get It

The Role of in-Person Support Groups in the Management of Urinary Incontinence in Women from a Mixed-Methods, Randomized Pilot Study
Toma, Gina , Carolan, Alexandra , Buckner‐Petty, Skye , Vargas, Laura, Wolter, Christopher , Khan, Aqsa

No container title available | October 27, 2021 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.21203/rs.3.rs-962324/v1 Get It

Abstract Background To assess the feasibility and acceptability of in-person support groups as a potential intervention for female patients with urinary incontinence. Methods Women over the age of 18 seeking treatment for UI were randomized to standard care with support group participation or to standard care alone. All participants completed validated questionnaires at the beginning and conclusion of the study. Questionnaires were analyzed with repeated measures of ANOVA models in an intention-to-treat manner. Three moderated support group sessions were held and audio recorded. Recordings were transcribed and categorized by frequency into themes using grounded theory methodology. Results A total of 10 control and 8 intervention participants agreed to participate. Seven women attended all three support group sessions and were included in the final analysis. Transcripts from support group sessions observed women identified most with (1) urinary incontinence (UI) as a chronic disease, (2) shame managing UI, and (3) social constraints of toileting. Support participants self-reported appreciation of support group participation and desire for on-going sessions. Analysis of the questionnaires did not demonstrate statistically significant differences. Conclusion Data ascertained from questionnaires was unable to demonstrate a meaningful effect in improved treatment outcomes for control and intervention participants. Grounded theory analysis of transcripts identified four primary themes: (1) appreciation of the support group, (2) UI as a gendered issue, (3) lack of public awareness, and (4) history of negative provider interactions. All support group participants self-reported interest in attending future support group sessions.
S967 The Correlation Between Visceral Abdominal and Total Adipose Tissue With Metabolic Risk Factors in Patients With Inflammatory Bowel Diseases
Yarur, Andrés , Núñez, Lizbeth, Berens, Brandon, Moosreiner, Andrea , Sekhri, Shaina , Beniwal‐Patel, Poonam , Bruss, Alexandra, Yarur, Andres J , Wiesner, Matthew, Deepak, Parakkal , Loftus, Edward V.

American Journal of Gastroenterology | October 24, 2021 | Volume: 116 | Issue: 1 | Pages: S463-S463

10.14309/01.ajg.0000777400.37055.33 Get It

S772 Risankizumab Therapy Induces Improvements in Endoscopic Endpoints in Patients With Moderate-To-Severe Crohn’s Disease: Results From the Phase 3 ADVANCE and MOTIVATE Studies
Ferrante, Marc , Baert, Filip , Feagan, Brian G. , Ran, Zhihua , D’Haens, Geert , Song, Alexandra , Neimark, Ezequiel, Liao, Xiaomei, Berg, Sofie, Wallace, Kori, Bossuyt, Peter , Danese, Silvio , Loftus, Edward V. , Panés, Julián , Peyrin‐Biroulet, Laurent , Armuzzi, Alessandro , Zhou, Qian , Panaccione, Remo

American Journal of Gastroenterology | October 24, 2021 | Volume: 116 | Issue: 1 | Pages: S357-S358

10.14309/01.ajg.0000776620.39225.48 Get It

S754 Risankizumab as Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease Who Failed 1 vs >1 Prior Biologic Treatment: Results From the MOTIVATE Study
Dubinsky, Marla C. , Ferrante, Marc , Song, Alexandra , Liao, Xiaomei, Berg, Sofie, Duan, W. Rachel, Wallace, Kori, Feagan, Brian G. , Panaccione, Remo , Schreiber, Stefan , Peyrin‐Biroulet, Laurent , Loftus, Edward V. , Huang, Bidan

American Journal of Gastroenterology | October 24, 2021 | Volume: 116 | Issue: 1 | Pages: S348-S348

10.14309/01.ajg.0000776548.94565.6c Get It

Association Between Tumor Necrosis Factor Inhibitors and the Risk of Hospitalization or Death Among Patients With Immune-Mediated Inflammatory Disease and COVID-19
Mahil, Satveer K. , Dand, Nick , Yiu, Zenas Z N , Zhang, Xian , Strangfeld, Anja , Mateus, Elsa F , Lawson‐Tovey, Saskia , Cuomo, Giovanna , Caprioli, Marta , Cruz-Machado, Ana Rita , Pereira, Ana Carolina Mazeda, Hasseli, Rebecca , Lorenz, Hanns‐Martin , Hoyer, Bimba F. , Trupin, Laura , Rush, Stephanie, Schmajuk, Gabriela , Jacobsohn, Lindsay, Seet, Andrea M. , Emadi, Samar Al, Wise, Leanna , Gilbert, Emily, Valenzuela-Almada, Maria O , Hsu, Tiffany , Sparks, Jeffrey A. , Xavier, Ricardo Machado , Flipo, René‐Marc , Cantagrel, A., Wallace, Zachary S. , Bhana, Suleman , Costello, Wendy, Grainger, Rebecca , Hausmann, Jonathan S. , Sufka, Paul , Machado, Pedro , Barker, Jonathan N., Smith, Catherine , Coker, Bola , Gisondi, Paolo, Jullien, D., Lambert, Jo, McAteer, Helen , Meynell, Freya, Moorhead, Lucy, Naldi, Luigi, Reynolds, Nick J. , Spuls, Phyllis, Vincent, Alexandra , Waweru, H, Reinisch, Walter , Rahier, Jean‐François , Lewis, James D. , Steinwurz, Flávio , Kissous-Hunt, Michele, Modesto, Irene , Konings, Marishka, Dahou, Brahim, Gómez, Gimena, Roberts, Karen , Báez, Roberto Miguel , Coello, Vanessa Viviana Castro , Salinas, María Jezabel Haye , Maldonado, F., Reyes, Alvaro A., Alle, Gelsomina , Tanten, Romina , Ficco, Hernán Maldonado , Tissera, Yohana , Pisoni, Cecilia , Paula, Alba, Albiero, Juan Alejandro, Schmid, María Marcela, Cosatti, Micaela , Gamba, María Julieta , Leandro, Carlevaris, Cusa, María Alejandra, Germán, Noelia, Bellomio, Verónica , Takashima, Lorena , Pera, Mariana , Elkin, M. S. Gálvez , Medina, María Alejandra , Savio, V. , Tessel, Romina Rojas, Alamino, Rodolfo Pérez, Werner, Marina Laura, Ornella, Sofía , Casalla, Luciana, Vega, María Celina De la , Severina, María de los Ángeles , Lucero, Luciana González , Romeo, Cecilia, Barbich, Tatiana, Baños, Andrea, Petruzzelli, Sandra, Matellan, Carla , Conti, Silvana, Lázaro, María Alicia, Gil, Gustavo Fabián Rodriguez, Risueño, Fabián, Quaglia, María Isabel, Scafati, Julia , Cuchiaro, Natalia Lili, Rebak, J., Pineda, Susana , Calvo, María Elena, Picco, Eugenia, Yanzi, Josefina Gallino , Maid, Pablo, Guaglianone, Debora, Morbiducci, Julieta Silvana , Porta, Sabrina , Herscovich, Natalia , Zamora, José Luis Velasco , Kisluk, Boris, Menescardi, Maria Sol Castaños, Gallo, Rosana, Maldini, Carla , Goizueta, Cecilia, Fernandez, Sabrina Solange de la Vega, Aeschlimann, Carolina, Subils, Gisela, Piette, Y, Devinck, Mieke , Maeyaert, Bea, Ribeiro, Francinne Machado , Ribeiro, Sandra Lúcia Euzébio , Trubert, Anne-Marie Chassin, Dong, Lingli , Cajas, Lui, Anić, Branimir, Čulo, Melanie-Ivana , Pavelic, Tea Ahel, Stranski, Kristina Kovacevic, Karanović, Boris , Píchová, Marta, Vassilopoulos, Dimitrios, Melgar, Gabriela Maria Guzman, Király, Márta , Vojdanian, Mahdi, Balbir‐Gurman, Alexandra , Abutiban, Fatemah , Buliņa, Inita , Bukauskienė, Loreta, Montiel, Beatriz E Zazueta, Ortiz, Angel Alejandro Castillo , Tehozol, Erick Adrian Zamora , Rosete, Diana Cervántes, Nares, Eduardo Martín, Reyna, Tatiana S Rodriguez, Gabayet, Marina Rull, Rodríguez, Deshiré Alpízar, Irazoque, Fedra, Jimenez, Xochitl, Bon, Lenny Geurts van, Zijlstra, T. R., Hoekstra, Monique , Adhoubi, Nasra Al , Salim, Babur , Giraldo, Enrique, Salinas, Ariel, Gil, Manuel Ugarte, Flood, Rachael , Felea, Ioana , Filipescu, Ileana, Rednic, Simona , Tamas, Maria Magdelena, Mlynáriková, Vanda , Skamlova, Martina, Žlnay, Martin, Mičeková, Dagmar, Cápová, L, Šteňová, Emὄke , Raffayová, Helena , Belakova, Gabriela, Straková, Eva , Senčarová, Marieta, Žlnayová, Soňa, Sabová, Anna, Spišáková, Daniela, Oetterová, Mária, Lukáčová, Oľga, Bakošová, Martina, Hočevar, Alojzija , Rubio, N. De la Torre , Sancho, Juan José Alegre , Coro, Montserrat Corteguera, García, Juan Carlos Cobeta , Martin, Maria Carmen Torres, Campos, José Luis Michi , Gómez‐Puerta, José A. , Yardimci, Gozd Kubra, İçaçan, Ozan Cemal , Çelik, Selda , Vasylets, Viktoriia, Vandevelde, Claire , Dunt, Sasha, Leeder, Jane, MacPhie, Elizabeth, Salerno, Rosaria, Graver, Christine, Williams, Katie, O’Reilly, Sheila, Devine, Kirsty, Tyler, Jennifer , Warner, Elizabeth, Pilcher, James, Patel, Samir J. , Nikiphorou, Elena , Chadwick, Laura , Jones, Caroline Mulvaney, Harrison, Beverley, Thornton, Lucy, O'Kane, Diana, Fusi, Lucia, Low, Audrey, Horton, Sarah , Jatwani, Shraddha , Baig, Sara , Bajwa, Hammad, Berglund, Vernon, Dahle, Angela, Dorman, Walter, Hargrove, Jody, Hilton, Maren, Lebedoff, Nicholas, Leonard, Susan, Pfeifer, Emily, Skemp, Archibald, Wolff, Anne , Cepeda, Eduardo, Todd, Derrick J. , Hare, Denise, Kilian, Adam, White, Douglas, Winter, Melanie, Fields, Theodore, Siegel, Caroline H. , Daver, Nicole, Harvey, Melissa , Kramer, Neil , Lamore, Concetta, Hogarty, Suneya, Yeter, Karen, Siddique, Faizah, Ban, Byung, Tanner, Tamar, Davis, William E. , Quinet, Robert, Scopelitis, Evangeline, Toribio, Karen Toribio, Detiege, Tameka Webb, Zakem, Jerald, Abbass, Khurram, Kepecs, Gilbert, Miranda, Lilliam, Guma, Michael, Haikal, Ammar, Mody, Sushama, Mueller, Daric, Zell, JoAnn, Dao, Kathryn H., Ezzati, Fatemeh, Parks, Deborah, Karp, David R. , Quiceno, Guillermo Andrés, Gilbert, Emily L , Sparks, Jeffrey A , Grainger, Rebecca , Hoyer, Bimba F , Wise, Leanna M , Lawson-Tovey, Saskia , Machado, Pedro M , Hausmann, Jonathan S , Hasseli, Rebecca , Xavier, Ricardo M , Hsu, Tiffany Y-T , Strangfeld, Anja , Mateus, Elsa F , Zamora Tehozol, Erick Adrian , Gomez-Puerta, Jose A , Izadi, Zara , Brenner, Erica J. , Yates, Mark , Ungaro, Ryan C. , Agrawal, Manasi , Colombel, Jean‐Frédéric , Gianfrancesco, Milena A , Hyrich, Kimme L , Carmona, Loreto , Klingberg, Eva , Mazeda, Carolina , Pfeil, Alexander , Katz, Patricia , Duarte‐García, Alí , Isnardi, Carolina A , Quintana, Rosana M , Soriano, Enrique Roberto , D'Silva, Kristin M , Patel, Naomi J , Marques, Cláudia Diniz Lopes , Kakehasi, Adriana María , Claudepierre, Pascal , Goupille, Philippe , Liew, Jean W. , Sirotich, Emily , Robinson, Philip C. , Griffiths, Christopher E.M. , Barker, Jonathan N., Yazdany, Jinoos , Kappelman, Michael D. , Bachelez, Hervé , Capon, Francesca , Cruz, Claudia de la , Mason, Kayleigh J. , Meglio, Paola Di , Gelfand, Joel M. , Gisondi, Paolo , Iversen, Lars , Langan, Sinéad , Puig, L. , Torres, Tiago , Tsakok, Teresa , Warren, Richard Bruce , Ng, Siew C. , Gearry, Richard B. , Reinisch, Walter , Lewis, James D , Kaplan, Gilaad G. , Maldonado, Federico N, Nieto, Romina , Gobbi, Carla Andrea , Cogo, Karina, García, Mercedes , Moyano, Sebastián , Bertoli, Ana María , Martiré, María Victoria , Rath, Eva, Piette, Yves, Pinheiro, Marcelo M. , Ibañez, Sebastián , Barešić, Marko , Vencovský, Jiří , Filková, Mária , Hamoud, Hesham Salah , So, Ho , Zepa, Jūlija , Vega‐Morales, David , Reyna, Tatiana Sofía Rodríguez, Nowakowski, Jarosław , Conway, Richard , McCarthy, Géraldine , Filipescu, I., Groseanu, Laura , Macejová, Želmíra , Strakova, Eva, Campos, Jose, Akar, Servet , Yeoh, Su‐Ann , Morgan, Jennifer , Wilson, Jeffrey, Wolff, Anne, Hare, Denise, Calabrese, Cassandra M. , Adams, Christopher, Khosroshahi, Arezou , Ruderman, Eric , Jayatilleke, Arundathi , Bays, Alison , Parks, Deborah

JAMA Network Open | October 20, 2021 | Volume: 4 | Issue: 10 | Pages: e2129639

10.1001/jamanetworkopen.2021.29639 | PMID 34661663 Get It