scholarly journals 470 Percutaneous arterial closure devices and ultrasound-guided trans-femoral puncture observational investigation: insights from the PETRONIO registry

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Gianmarco Iannopollo ◽  
Giampiero Nobile ◽  
Valerio Lanzilotti ◽  
Alessandro Capecchi ◽  
Roberto Verardi ◽  
...  
Keyword(s):  
Phase 1 ◽  
Control Period ◽  
Multivariable Analysis ◽  
Study Endpoint ◽  
Primary Study ◽  
Ultrasound Guided ◽  
Bleeding Events ◽  
Access Site ◽  
Arterial Access ◽  
Femoral Puncture

Abstract Aims To evaluate the safety of a single and combined use of ultrasound-guided femoral puncture (U) and percutaneous arterial closure devices (P) in femoral artery procedures (FAP) compared to fluoroscopic guidance (F) and manual compression (M) in a large radial-focused interventional centre. U and P, taken individually, have improved safety in femoral arterial access procedures compared to traditional techniques. Methods and results All FAP performed between July 2017 and December 2018 in our centre were divided into three phases: (i) control period with F and M mainly performed; (ii) phase out period where U and P were introduced; and (iii) intervention period where a 6-month expertise on the novel techniques was acquired. The overall population was further stratified into subgroups: F/M, U/M, F/P, and U/P. The primary study endpoint was in-hospital access site bleeding events (BE) according to the BARC criteria. The secondary endpoint was vascular site complications (VASC). 418 procedures (14%) out of 3025 were performed via FA access during the study period. The overall access-site in-hospital BE were 97 (23%). Decreasing rates of BE (phase 1: n = 46, 29%; phase 2: n = 38, 22% e phase 3: n = 13, 15%; P = 0.027) and VASC were observed during the three periods. BE occurred significantly more often in F/M group (F/M: n = 48; 32%; U/M: n = 12, 16%; F/P: n = 18, 21%; U/P: n = 19, 17%; P = 0.008). F/M subgroup was an independent predictor of BE both in multivariable analysis and propensity score matching analysis. Conclusions The introduction of ultrasound-guided femoral puncture and percutaneous arterial closure devices has reduced access site bleeding with a progressive improvement after the first 6 months learning period.

403 Early results from a phase 1 study to evaluate safety, pharmacokinetics, and efficacy of AMG 404, a programmed death-1 (PD-1) antibody, in patients with advanced solid tumors

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A428-A428
Author(s):  
Timothy Price ◽  
Sant Chawla ◽  
Gerald Falchook ◽  
Hans Prenen ◽  
Iwona Lugowska ◽  
...  
Keyword(s):  
Partial Response ◽  
Solid Tumors ◽  
Clear Cell ◽  
Phase 1 ◽  
Cell Cancer ◽  
Objective Response ◽  
Study Endpoint ◽  
Primary Study ◽  
Pharmacokinetic Parameters ◽  
Advanced Solid Tumors

BackgroundEnhancement of antitumor immunity through inhibition of the checkpoint PD-1 receptor has been effective in the treatment of many malignancies. AMG 404 is a monoclonal antibody (mAb) targeting PD-1. This phase 1, open-label, multicenter first-in-human study (NCT03853109) will evaluate the safety, tolerability, pharmacokinetics, and efficacy of AMG 404 monotherapy in adult patients with advanced solid tumors.MethodsThe primary study endpoint is dose-limiting toxicity (DLT) and safety; key secondary endpoints include pharmacokinetic parameters, objective response rate (assessed Q8W), duration of response, and progression-free survival. Key inclusion criteria include histologically or cytologically proven metastatic or locally advanced solid tumors not amenable to curative treatment with surgery or radiation for which standard therapies have been exhausted or not available. Prior anti-PD-(L)1 or other checkpoint inhibitors were not allowed. Five dose-finding cohorts, including 2 expansion cohorts, ranged from 3–20 patients each. AMG 404 was given until disease progression, intolerance, or consent withdrawal.ResultsAs of the data cutoff date of May 4, 2020, 62 patients received at least 1 dose of AMG 404 and were included in the safety and efficacy analysis sets. Fifty percent were men, 72% had ECOG 1 performance status, median age was 62 years (range: 28–83), and 42% had ≥3 lines of prior anticancer therapy. Median AMG 404 exposure was ~3 months (maximum: ~12 months). No DLTs were observed. Treatment-related adverse events (TRAEs) were reported for 29 patients (47%): those reported for ≥2 patients were fatigue (n=7); hypothyroidism (n=6); increased blood thyroid stimulating hormone and nausea (n=4 each); increased aspartate aminotransferase, decreased appetite, and pyrexia (n=3 each); and increased alanine aminotransferase, arthralgia, diarrhea, and increased weight (n=2 each). AEs leading to withdrawal of AMG 404 were reported for 3 patients (5%); all were serious and considered to be not related to AMG 404. Sixteen (26%) patients died on study; no deaths were considered related to AMG 404. Preliminary pharmacokinetic results were consistent with those of other therapeutic anti-PD-1 mAbs. Three patients had a confirmed partial response (pancreatic cancer, clear cell cancer, and pleomorphic sarcoma); an additional 4 patients had one scan with a partial response and are pending a confirmatory scan (clear cell renal carcinoma, undifferentiated nasopharyngeal carcinoma, sarcomatoid carcinoma of unknown primary, and colon cancer).ConclusionsAMG 404 is tolerable at the tested doses with no DLTs reported. All observed TRAEs are consistent with other anti-PD-1 therapies. Encouraging anti-tumor activity has been observed in heavily pretreated patients. The study is continuing enrollment into additional cohorts.Trial RegistrationNCT03853109Ethics ApprovalThe study was approved by the Ethics Board of each institution involved in this study and can be produced upon request.

scholarly journals Ultrasound-guided epidural anesthesia and sedation foropen abdominal surgery in 20 consecutive children:a prospective case series and proof-of-concept study

2020 ◽  
Author(s):  
Werner Schmid ◽  
Philipp Opfermann ◽  
Markus Zadrazil ◽  
Ursula Tonnhofer ◽  
Martin Metzelder ◽  
...  
Keyword(s):  
Abdominal Surgery ◽  
Airway Management ◽  
Epidural Anesthesia ◽  
Recovery Room ◽  
Case Series ◽  
Skin Incision ◽  
Study Endpoint ◽  
Primary Study ◽  
Ultrasound Guided ◽  
Drug Induced

Abstract General anesthesia (GA) in children is associated with respiratory events and a potential for drug-induced neurotoxicity. Aiming to reduce airway manipulation and the use of GA drugs, we designed a study of abdominal surgery under epidural anesthesia in sedated, spontaneously breathing children. We enrolled 20 children (3 − 83 months, 6.3 − 25.0 kg) scheduled for open abdominal surgery with Pfannenstiel incision. Sedation was followed by ultrasound-guided epidural anesthesia. Increases in heart rate by > 15% and or patient movements upon skin incision were rated as block deficiencies. Intubation equipment for advanced airway management was kept on standby. The primary study endpoint was successful blockade, meaning that no sequential airway management was required during surgery. Secondary endpoints included any use of fentanyl/propofol intraoperatively and of postoperative analgesics in the recovery room. All 20 blocks were successful, with no block deficiencies upon skin incision, no need for sequential airway management, and stable SpO2 levels (97–100%). Surgery took a median of 120.5 minutes (IQR: 89.3–136.5) and included one bolus of fentanyl 120 minutes into a protracted operation. No more systemic analgesia had to be provided in the recovery room. Sedation and epidural anesthesia emerged as a useful alternative to GA from our consecutive case series.

scholarly journals Design and Rationale of the Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) Study

2015 ◽  
Vol 9 ◽  
pp. CMC.S31932 ◽  
Author(s):  
Michael Behnes ◽  
Melike Ünsal ◽  
Ursula Hoffmann ◽  
Christian Fastner ◽  
Ibrahim El-Battrawy ◽  
...  
Keyword(s):  
Vascular Complications ◽  
Classification Systems ◽  
Radial Compression ◽  
Percutaneous Coronary Interventions ◽  
Cardiac Events ◽  
Bleeding Events ◽  
Access Site ◽  
Arterial Access ◽  
Coronary Interventions ◽  
Percutaneous Coronary

Background Bleeding events after percutaneous coronary interventions (PCI) are associated with patients' age, gender, and the presence of chronic kidney disease, antithrombotic treatment, as well as arterial access site. Patients being treated by PCI using radial access site are associated with an improved prognosis. However, the safety of femoral closure devices has never been compared to radial compression devices following PCI. Therefore, the aim of this study is to evaluate the safety of femoral closure compared to radial compression devices in patients treated by PCI envisaging access site bleedings as well as short- and long-term prognostic outcomes. Methods The Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) study is a single-center observational study comparing 400 consecutive patients undergoing PCI either using radial compression devices (TR Band™) or femoral closure devices (Angio-Seal™) at the corresponding access site. The primary outcome consists of the occurrence of vascular complications at the arterial access site, including major bleedings as defined by common classification systems. Secondary outcomes consist of the occurrence of adverse cardiac events, including all-cause mortality, target lesion revascularization, and target vessel revascularization during 30 days and 12 months of follow-up. Results Study enrollment was initiated in February 2014. The enrollment phase is expected to last until May 2015. Conclusions The FERARI study intends to comparatively evaluate the safety and prognostic outcome of patients being treated by radial or femoral arterial closure devices following PCI during daily clinical practice.

A phase 3, randomized, 3-arm study of temsirolimus (TEMSR) or interferon-alpha (IFN) or the combination of TEMSR + IFN in the treatment of first-line, poor-risk patients with advanced renal cell carcinoma (adv RCC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. LBA4-LBA4 ◽  
Author(s):  
G. Hudes ◽  
M. Carducci ◽  
P. Tomczak ◽  
J. Dutcher ◽  
R. Figlin ◽  
...  
Keyword(s):  
Clin Oncol ◽  
Risk Group ◽  
Phase 1 ◽  
Single Agent ◽  
Specific Inhibitor ◽  
Study Endpoint ◽  
Primary Study ◽  
First Line ◽  
Phase 3 ◽  
Poor Risk

LBA4 Background: Temsirolimus (TEMSR, CCI-779) is a specific inhibitor of mTOR, a signaling protein that regulates cell growth and angiogenesis. In a single-agent, phase 2 study, TEMSR administration to heavily pretreated patients (pts, n = 111) with adv RCC resulted in a median overall survival (OS) of 15.0 mos (Atkins et al, J Clin Oncol 2004). Retrospectively, 49 pts were categorized in a poor-risk group (Motzer et al, J Clin Oncol 2002). The TEMSR-treated pts in this group had a 1.7-fold longer median OS than the first-line, IFN-treated, poor-risk group reported by Motzer et al. In a phase 1 study, the maximum tolerated dose of the combination of TEMSR + IFN in adv RCC pts was TEMSR 15 mg intravenously (IV) once/wk + IFN 6 million units (MU) subcutaneously (SC) 3 times weekly (TIW) (Smith et al, Proc ASCO 2004). Thus, this phase 3 study in first-line, poor-risk adv RCC pts was initiated in July 2003. Methods: Pts with adv RCC and no prior systemic therapy were enrolled in this open-label study if they had ≥3 of 6 risk factors (the 5 Motzer criteria and >1 metastatic disease site). Pts were randomized (1:1:1) to arm 1, IFN up to 18 MU SC TIW; arm 2, TEMSR 25 mg IV once/wk; or arm 3, TEMSR 15 mg IV once/wk + IFN 6 MU SC TIW. The primary study endpoint was OS; the study was powered to compare the TEMSR arms with the IFN arm. Results: We report 20 Mar 2006 preliminary data from an interim analysis performed by the IDMC. Of the 626 pts enrolled, 442 deaths occurred. Patients treated with TEMSR had a statistically longer survival than those treated with IFN (Table). OS of patients treated with IFN and TEMSR + IFN were not statistically different. The 3 most frequently occurring adverse events ≥gr 3 were asthenia (arm 1: arm 2: arm 3, 27%: 12%: 30% pts), anemia (24%: 21%: 39% pts), and dyspnea (8%: 9%: 11% pts). Conclusions: Single-agent TEMSR significantly increases the OS of first-line, poor-risk adv RCC pts compared with IFN, with an acceptable safety profile. [Table: see text] [Table: see text]

scholarly journals Thromboprophylaxis in congenital nephrotic syndrome: 15-year experience from a national cohort

2020 ◽  
Author(s):  
Laurence J. Dobbie ◽  
Angela Lamb ◽  
Lucy Eskell ◽  
Ian J. Ramage ◽  
Ben C. Reynolds
Keyword(s):  
Nephrotic Syndrome ◽  
Factor Xa ◽  
Congenital Nephrotic Syndrome ◽  
Study Endpoint ◽  
Primary Study ◽  
Duration Of Treatment ◽  
Bleeding Events ◽  
Therapeutic Anticoagulation ◽  
Primary Study Endpoint ◽  
National Cohort

Abstract Introduction Congenital nephrotic syndrome (CNS) is an ultra-rare disease associated with a pro-thrombotic state and venous thromboembolisms (VTE). There is very limited evidence evaluating thromboprophylaxis in patients with CNS. This study aimed to determine the doses and duration of treatment required to achieve adequate thromboprophylaxis in patients with CNS. Methods From 2005 to 2018 children in Scotland with a confirmed genetic or histological diagnosis of CNS were included if commenced on thromboprophylaxis. The primary study endpoint was stable drug monitoring. Secondary outcomes included VTE or significant haemorrhage. Results Eight patients were included; all initially were commenced on low-molecular weight heparin (enoxaparin). Four patients maintained therapeutic anti-Factor Xa levels (time 3–26 weeks, dose 3.2–5.07 mg/kg/day), and one patient developed a thrombosis (Anti-Factor Xa: 0.27 IU/ml). Four patients were subsequently treated with warfarin. Two patients maintained therapeutic INRs (time 6–11 weeks, dose 0.22–0.25 mg/kg/day), and one patient had two bleeding events (Bleed 1: INR 6, Bleed 2: INR 5.5). Conclusions Achieving thromboprophylaxis in CNS is challenging. Similar numbers of patients achieved stable anticoagulation on warfarin and enoxaparin. Enoxaparin dosing was nearly double the recommended starting doses for secondary thromboprophylaxis. Bleeding events were all associated with supra-therapeutic anticoagulation.

High-Dose Gemcitabine Combined With Busulfan and Melphalan (Gem/Bu/Mel) With Autologous Stem-Cell Transplant (ASCT) In Refractory and Relapsed Myeloma

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3346-3346
Author(s):  
Yago Nieto ◽  
Nina Shah ◽  
Uday R Popat ◽  
Roy B Jones ◽  
Qaiser Bashir ◽  
...  
Keyword(s):  
Research Funding ◽  
Phase 1 ◽  
Single Agent ◽  
Fixed Dose ◽  
Study Endpoint ◽  
Primary Study ◽  
High Dose ◽  
Cell Transplant ◽  
Line Therapy

Abstract Introduction More active high-dose (HD) regimens are needed for refractory myeloma, where single-agent melphalan offers poor outcomes. Registry data suggest that busulfan/melphalan might be superior to melphalan in 1st-line treatment of chemosensitive patients. While gemcitabine has potent activity in vitro against resistant myeloma cell lines, this drug has shown little activity in patients with resistant myeloma when tested in short 30-min infusions. Gemcitabine cytotoxicity correlates with the intracellular accumulation of its active triphosphate metabolite, which is optimized when infused at a fixed dose rate (FDR) of 10 mg/m2/min. We previously developed a HD regimen of Gem/Bu/Mel, infusing gemcitabine at FDR and exploiting its inhibition of DNA damage repair, with a manageable toxicity profile. In its phase 1 trial (Nieto, BBMT 2012) Gem/Bu/Mel showed some encouraging signs of activity in patients with refractory myeloma. Thus, we wished to study Gem/Bu/Mel in refractory myeloma patients who either had an estimated CR likelihood <15% with high-dose melphalan or had disease that previously failed HD Mel, whose median PFS after a 2nd ASCT is typically ≤1 year (Qazilbash, Cancer 2006; Michaelis, BBMT 2013). Methods Patients ages 18-70, with myeloma treated in 1st-line therapy with lenalidomide, bortezomib or thalidomide, plus ≥1 of the following 3 criteria: no response to 1st-line therapy, relapse after 1st-line therapy, or relapse after prior ASCT, along with adequate end-organ function, were eligible for this phase 2 study. Gemcitabine was given on days -8 and -3 as a loading dose of 75 mg/m2 followed by FDR infusion of 1,800 mg/m2. Busulfan was given on days -8 to -5 targeting AUC 4,000/day x 4. Melphalan was given at 60 mg/m2/day x 2 (days -3 and -2). The primary study endpoint was CR rate (determined by day 100 before starting maintenance treatment); secondary endpoints were CR+VGPR, RR, PFS and OS. This trial was sized with >85% power to detect a CR rate ≥20%, which was considered clinically significant. Results Between 11/10 and 6/13, 60 patients were enrolled, all of whom had failed at least 1 line of therapy (Table). Neutrophils and platelets engrafted on d+10 (8-13) and d+11 (9-16), respectively. There were 3 treatment-related deaths (4.9% TRM: 1 pneumonia, 1 cardiac arrest with unrevealing autopsy, 1 E coli sepsis). Toxicities: mucositis (50% G2, 18% G3), rash (20% G2, 6% G3), asymptomatic transaminase elevation (17% G2, 8% G3) and bilirubin elevation (3% G2, 10% G3) (no cases of VOD), with no renal, cardiac, neurological or pulmonary toxicity. Among 49 patients with measurable disease at transplant and evaluable for response, the CR rate was 24.5% (95% CI, 16-32.5%), 42% CR/VGPR rate (36-50%), and 77.5% RR (71-83%). Posttransplant maintenance was given to 38 patients, using lenalidomide (N=23), bortezomib (N=11), thalidomide (N=3) and bendamustine (N=1). At median f/u of 16 months (range, 2-31), the PFS and OS rates are 55% (median 15 months) and 77% (median not reached), respectively (Figure). In the subset of 25 patients receiving Gem/Bu/Mel as a 2nd salvage ASCT, there were 1 CR, 2 VGPR and 7 PR for a CR+VGPR of 19%, RR 62.5%, with 52% PFS (median 15 months) and 68% OS (median NR). In the subset of 20 patients with high-risk cytogenetics (N=20), there were 28% CR, 56% CR+VGPR and 83% RR, with 55% PFS (median 14 months) and 80% OS (median NR). Conclusions Gem/Bu/Mel is a safe and highly active HD regimen in refractory myeloma and warrants its further study in earlier stages of this disease. Disclosures: Nieto: Otsuka Pharmaceuticals: Research Funding. Off Label Use: Gemcitabine not approved for myeloma. Qazilbash:Otsuka Pharmaceuticals: Research Funding.

scholarly journals Increased symmetric dimethyl-arginine is a predictor factor of decreased platelet reactivity and increased bleeding risk in patients with acute coronary syndrome

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
C Eyileten ◽  
J Jarosz-Popek ◽  
D Jakubik ◽  
A Gasecka ◽  
M Wolska ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Coronary Syndrome ◽  
Platelet Reactivity ◽  
Bleeding Risk ◽  
Bleeding Complications ◽  
Study Endpoint ◽  
Primary Study ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Coronary Syndrome

Abstract Background One of the promising biomarkers in CVD are asymmetric dimethylarginine (ADMA) and symmetric dimethylarginine (SDMA), which are products of L-arginine methylation and are both involved in endothelial dysfunction. ADMA, SDMA and L-homoarginine, have emerged as biomarkers linked to cardiovascular outcomes [1]. Purpose To investigate the association of SDMA with platelet reactivity and bleeding risk in patients with acute coronary syndrome (ACS) treated with potent P2Y12 inhibitors prasugrel and ticagrelor. Methods Our prospective observational study enrolled 292 patients with ACS undergoing percuteneus coronary intervention [2]. Plasma concentrations of SDMA were measured during the hospitalization for ACS. Impedance aggregometry was used. The primary study endpoint was the concentration of metabolites and platelet reactivity. The primary clinical outcome endpoint was the incidence of Thrombolysis in Myocardial Infarction (TIMI) bleeding events (major, minor and minimal). The efficacy endpoint was the composite of major adverse cardiac events (MACE: stent thrombosis, myocardial infarction, stroke and cardiac death). Results There was an inverse correlation between SDMA serum levels and platelet reactivity (r=−0.25; p&lt;0.000). The ADP+PGE1-induced platelet reactivity was 33% lower among patients with the highest SDMA quartile (4th) as compared to those with the 1–3rd SDMA quartile (8 [0–29] vs 12 [0–126] U; p&lt;0.001). The AA-induced platelet reactivity was 56% lower among patients with the highest SDMA quartile (4th) as compared to those with the 1–3rd SDMA quartile (4 [0–48] vs 9 [0–133]; p&lt;0.001). In a multivariate model, the highest SDMA (4th) quartile was found to be an independent predictor of the lowest ADP+PGE1 and AA induced platelet aggregation (OR: 2.666, 95% CI [1.184–5.999], p=0.018). Conclusions Our study shows that high plasma concentration of SDMA, but not ADMA, is independently associated with low platelet reactivity to ADP and AA and is associated with major and minor bleeding events in patients with ACS on potent antiplatelet therapies. Therefore, SDMA might have a potential to be further evaluated as a blood biomarker for individualization of duration and potency of antiplatelet therapies in an ACS population at high risk of bleeding complications. Acknowledgment I-COMET research team FUNDunding Acknowledgement Type of funding sources: None. Figure 1 Table 1

scholarly journals Mortality after cardiopulmonary resuscitation on a medical ICU

2021 ◽  
Author(s):  
Richard Rezar ◽  
Bernhard Wernly ◽  
Michael Haslinger ◽  
Clemens Seelmaier ◽  
Philipp Schwaiger ◽  
...  
Keyword(s):  
Cardiopulmonary Resuscitation ◽  
Neurological Outcome ◽  
Cox Regression ◽  
Cerebral Performance Category ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Study Endpoint ◽  
Primary Study ◽  
Postresuscitation Care ◽  
Significant Difference

Summary Background Performing cardiopulmonary resuscitation (CPR) and postresuscitation care in the intensive care unit (ICU) are standardized procedures; however, there is evidence suggesting sex-dependent differences in clinical management and outcome variables after cardiac arrest (CA). Methods A prospective analysis of patients who were hospitalized at a medical ICU after CPR between December 2018 and March 2020 was conducted. Exclusion criteria were age < 18 years, hospital length of stay < 24 h and traumatic CA. The primary study endpoint was mortality after 6 months and the secondary endpoint neurological outcome assessed by cerebral performance category (CPC). Differences between groups were calculated by using U‑tests and χ2-tests, for survival analysis both univariate and multivariable Cox regression were fitted. Results A total of 106 patients were included and the majority were male (71.7%). No statistically significant difference regarding 6‑month mortality between sexes could be shown (hazard risk, HR 0.68, 95% confidence interval, CI 0.35–1.34; p = 0.27). Neurological outcome was also similar between both groups (CPC 1 88% in both sexes after 6 months; p = 1.000). There were no statistically significant differences regarding general characteristics, pre-existing diseases, as well as the majority of clinical and laboratory parameters or measures performed on the ICU. Conclusion In a single center CPR database no statistically significant sex-specific differences regarding post-resuscitation care, survival and neurological outcome after 6 months were observed.

Derivation of a procedural performance checklist for ultrasound-guided femoral arterial line placement using the modified Delphi method

2020 ◽  
Vol 21 (5) ◽  
pp. 715-722
Author(s):  
Jessica Baez ◽  
Elizabeth Powell ◽  
Megan Leo ◽  
Uwe Stolz ◽  
Lori Stolz
Keyword(s):  
Delphi Method ◽  
Competency Assessment ◽  
Arterial Line ◽  
Ultrasound Guided ◽  
Arterial Access ◽  
Modified Delphi Method ◽  
Modified Delphi ◽  
Item Checklist ◽  
Standard Quality ◽  
Femoral Arterial Access

Background: Many specialties utilize procedural performance checklists as an aid to teach residents and other learners. Procedural checklists ensure that the critical steps of the desired procedure are performed in a specified manner every time. Valid measures of competency are needed to evaluate learners and ensure a standard quality of care. The objective of this study was to employ the modified Delphi method to derive a procedural checklist for use during placement of ultrasound-guided femoral arterial access. Methods: A 27-item procedural checklist was provided to 14 experts from three acute care specialties. Using the modified Delphi method, the checklist was serially modified based on expert feedback. Results: Three rounds of the study were performed resulting in a final 23-item checklist. Each item on the checklist received at least 70% expert agreement on its inclusion in the final checklist. Conclusion: A procedural performance checklist was created for ultrasound-guided femoral arterial access using the modified Delphi method. This is an objective tool to assist procedural training and competency assessment in a variety of clinical and educational settings.

A phase 3 study to evaluate the efficacy and safety of tafasitamab plus lenalidomide and rituximab versus placebo plus lenalidomide and rituximab in patients with relapsed/refractory (R/R) follicular lymphoma (FL) or marginal zone lymphoma (MZL).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS7568-TPS7568
Author(s):  
Laurie Helen Sehn ◽  
Christian W Scholz ◽  
Stefano Luminari ◽  
Antonio Salar ◽  
Bjorn E. Wahlin ◽  
...  
Keyword(s):  
B Cell ◽  
Clinical Benefit ◽  
B Cell Lymphoma ◽  
Study Endpoint ◽  
Primary Study ◽  
Cns Lymphoma ◽  
Phase 2 ◽  
Phase 3 ◽  
Potential Clinical Benefit ◽  
Anti Cd20

TPS7568 Background: Most patients with the indolent non-Hodgkin lymphoma (NHL) subtypes FL or MZL respond to first-line treatment but relapse is common, and there is no single standard treatment for patients with R/R FL or MZL. Tafasitamab is an Fc-engineered humanized monoclonal antibody (mAb) against CD19 which is broadly expressed in FL and MZL, and regulates B-cell proliferation via B-cell receptor signaling. In preclinical studies, tafasitamab has shown activity against NHL cell lines in combination with rituximab (anti-CD20 mAb) and lenalidomide (LEN). Tafasitamab monotherapy has shown promising clinical activity in a phase 2a study in patients with R/R NHL (NCT01685008), with an ORR of 29% (n/N = 10/34) in patients with FL and 33% (n/N = 3/9) in patients with MZL. In an ongoing phase 2, single-arm study (L-MIND, NCT02399085), tafasitamab plus LEN followed by tafasitamab alone demonstrated an ORR of 57.5% (n/N = 46/80) in patients with R/R diffuse large B-cell lymphoma (FDA approved indication). These preclinical and clinical observations from phase 2 trials suggest a potential clinical benefit of tafasitamab plus LEN and rituximab for patients with R/R FL or MZL. Methods: This phase 3 double-blind, placebo-controlled, randomized study is designed to investigate whether tafasitamab plus LEN and rituximab provides improved clinical benefit compared with LEN and rituximab in patients with R/R FL or R/R MZL. Patients will be randomized 1:1 to receive tafasitamab (12 mg/kg IV on days 1, 8, 15, and 22 of a 28-day cycle [cycles 1–3], then days 1 and 15 [cycles 4–12]) plus LEN (20 mg PO QD, days 1–21/ cycle for 12 cycles) and rituximab (375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1, then day 1 of cycles 2–5), or placebo (0.9% saline solution IV) plus LEN and rituximab. The primary study endpoint is PFS (investigator assessed [INV] by Lugano 2014 criteria) for patients with FL. Key secondary endpoints are PFS (INV) in overall population (FL and MZL), PET-CR rate (INV) at end of treatment (4–8 weeks after last treatment) and OS in patients with FL. Inclusion criteria include age ≥18 y, histologically confirmed FL (grade 1, 2, or 3a) or MZL (nodal, splenic, or extranodal), documented R/R disease, ≥1 prior systemic anti-CD20 therapy (including anti-CD20 refractory disease), ECOG PS ≤2, adequate systemic organ function, and high tumor burden (per GELF criteria). Exclusion criteria include prior rituximab plus LEN treatment, history of radiotherapy for other diseases (≥25% of bone marrow), nonhematologic malignancy, congestive heart failure (LVEF < 50%), active systemic infection, known CNS lymphoma, or severe immunocompromised state. inMIND (NCT04680052, EudraCT2020-004407-13) is currently enrolling patients; planned enrollment is 528 patients with R/R FL and 60–90 patients with R/R MZL. Clinical trial information: NCT04680052.

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