scholarly journals Compassionate use of recombinant human IL-7-hyFc as a salvage treatment for restoring lymphopenia in patients with recurrent glioblastoma

2022 ◽  
Author(s):  
Stephen Ahn ◽  
Jae-Sung Park ◽  
Heewon Kim ◽  
Minkyu Heo ◽  
Young Chul Sung ◽  
...  
Keyword(s):  
Adverse Events ◽  
Lymphocyte Count ◽  
Randomized Clinical Trials ◽  
Case Series ◽  
Recurrent Glioblastoma ◽  
Total Lymphocyte Count ◽  
Compassionate Use ◽  
Serious Adverse Events ◽  
Total Lymphocyte ◽  
Recurrent Gbm

Purpose Lymphopenia is frequently observed and is associated with poor prognosis in glioblastoma (GBM) patients. Restoring lymphopenia in cancer patients has been suggested as a novel immunotherapeutic strategy. As interleukin-7 (IL-7) is necessary for proliferation of lymphocytes and to amplify the total lymphocyte count (TLC), IL-7 therapy has been tried for various cancers, although the results are inconclusive. Here, we describe the clinical results of recurrent GBM treated with long-acting engineered version of recombinant human IL-7 (rhIL-7-hyFc). Methods This prospective case series based on compassionate use was approved by the Ministry of Food and Drug Safety in South Korea. Patients with recurrent GBM were enrolled to Seoul St. Mary's Hospital. Primary outcomes were the safety profile and elevated total lymphocyte count (TLC). Secondary outcomes were overall survival (OS) and progressionbfree survival (PFS). The duration of median follow up was 372.6 days (range 98-864 days). Results Among 18 patients enrolled, 10 received rhIL-7-hyFc with temozolomide, 5 received rhIL-7-hyFc with bevacizumab, 1 received rhIL-7-hyFc with PCV chemotherapy, and 2 received rhIL-7-hyFc alone. The mean TLC of enrolled patients after the first treatment with rhIL-7-hyFc was significantly increased from 1,131 cells/mm^3 (range 330-2,989) at baseline to 4,356 cells/mm^3 (range 661-22,661). Similar increase was observed in 16 of 18 patients (88.8%), only after the first treatment of rhIL-7-hyFc. TLCs of these patients were maintained higher while rhIL-7-hyFc was repeatedly administered. Most common adverse events were injection sites reactions (64.7%) including urticaria and itching sensation, however, there were no serious adverse events more than grade III. Median OS and PFS were 378 days (range 107-864 days) and 231 days (55-726 days), respectively. Conclusion Our study first reports that IL-7 immunotherapy can restore lymphopenia and maintain TLC with various salvageable chemotherapies in recurrent GBM patients without serious adverse toxicities. This outcome warrants further larger and randomized clinical trials to validate the clinical benefits of rhIL-7-hyFc for GBM patients.

scholarly journals ACTR-68. FEASIBILITY STUDY OF THE EMULATE THERAPEUTICS™ VOYAGER SYSTEM IN PATIENTS WITH RECURRENT GLIOBLASTOMA (GBM)

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi29-vi29
Author(s):  
Garni Barkhoudarian ◽  
Michael Badruddoja ◽  
Nicholas Blondin ◽  
Ricky Chen ◽  
Sajeel Chowdhary ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adverse Events ◽  
Skin Irritation ◽  
Recurrent Glioblastoma ◽  
Secondary Outcome ◽  
Open Label ◽  
Serious Adverse Events ◽  
Radio Frequency Energy ◽  
Long Term Treatment ◽  
Recurrent Gbm

Abstract BACKGROUND The EMulate Therapeutics Voyager system is an investigational non-sterile, non-invasive, non-thermal, non-ionizing, portable, home-use medical device that uses a specific, localized ultra-low radio frequency energy (ulRFE®) cognate for the treatment of brain cancer. METHODS This ongoing, open-label, multi-center study (NAT-101) is being conducted in the US and Australia in patients with recurrent GBM. There are 3 treatment groups: 32 patients treated with Voyager alone, 43 patients treated with Voyager + Investigator’s choice of anti-cancer therapy, and 21 patients treated with Voyager+lomustine+/-bevacizumab. The objective of the study is to assess if the Voyager is a safe and feasible treatment for recurrent GBM. The primary outcome measure is safety, assessed by the incidence and evaluation of adverse events (AEs) associated with the Voyager. The secondary outcome measures are progression-free survival and overall survival. RESULTS Enrollment is closed, and long-term treatment and follow-up is ongoing. 96 patients were enrolled and treated. 82 patients reported at least one AE, and 18 AEs were assessed as device-related (mild-moderate; 12 headache, 2 vomiting, 1 nausea, 1 confusion, 1 insomnia, and 1 skin irritation). 31 patients reported at least one serious AE, and none were assessed as device-related. 33% of patients treated with Voyager alone and 36% of patients treated with Voyager + chemotherapy were progression-free after 6 months. 58% of patients treated with Voyager alone and 60% of patients treated with Voyager + chemotherapy remained alive after 6 months; median overall survival is 7 months (95% CI=4.4±14.3) in patients treated with Voyager alone and 10 months (95% CI=6.7±11.5) in patients treated with Voyager + chemotherapy. CONCLUSIONS The Voyager system appears to be safe and feasible for the treatment of recurrent GBM. Given that therapy is delivered non-invasively and no device-related serious adverse events were reported, further prospective study of the investigational device is planned.

Correlation between total and CD4 lymphocyte counts in HIV infection: not making the good an enemy of the not so perfect

1996 ◽  
Vol 7 (6) ◽  
pp. 422-428 ◽  
Author(s):  
E J Beck ◽  
E J Kupek ◽  
M M Gompels ◽  
A J Pinching
Keyword(s):  
T Cell ◽  
Hiv Infection ◽  
Lymphocyte Count ◽  
Cell Subset ◽  
Total Lymphocyte Count ◽  
Aids Patients ◽  
T Cell Subset ◽  
Total Lymphocyte ◽  
Asymptomatic Patients ◽  
Cd4 Lymphocyte

The aim of this study was to assess the correlation and average cost of total lymphocyte count compared with CD4 count as a broad estimate of immunosuppression in HIV-1 infected individuals. Spearman's partial rank correlation were calculated between total lymphocyte count, absolute CD4 count and CD4 per cent stratified by stage of HIV-1 infection for routinely collected samples. Data were collected prospectively from a T cell-subset register combined with clinical data obtained retrospectively from case notes of HIV-infected patients managed at St Mary's Hospital, London 1982-1991. Costing data were obtained through a survey of the departments of haematology and immunology 1989 90 prices . The correlation between 1534 paired absolute lymphocyte count and CD4 lymphocyte count was found to be high R 0.76 . When analysed by stage of HIV infection, the correlation increased from R 0.64 for asymptomatic patients, to R 0.72 for patients with symptomatic non-AIDS HIV infection and R 0.73 for AIDS patients. Correlations between absolute lymphocyte count and CD4 per cent were considerably weaker: R 0.41 all paired counts; R 0.32 for asymptomatic patients; R 0.25 for symptomatic non-AIDS patients; R 0.32 for AIDS patients. Average cost was 8 per full blood count compared with 38 per T-cell subset analysis. The high correlation between total and CD4 lymphocyte counts, especially for patients with symptomatic HIV disease, demonstrates the suitability of the use of total lymphocyte count in the absence of CD4 counts. Given the considerably lower prices of total lymphocyte counts compared with T-cell subset analysis, this is particularly relevant for developing countries.

scholarly journals Safety of alemtuzumab in a nationwide cohort of Finnish multiple sclerosis patients

2021 ◽  
Author(s):  
Ilkka Rauma ◽  
Tiina Mustonen ◽  
Juha Matti Seppä ◽  
Maritta Ukkonen ◽  
Marianne Männikkö ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Case Series ◽  
Retrospective Case ◽  
Serious Adverse Events ◽  
Highly Active ◽  
Disease Modifying Therapy ◽  
Case Series Study ◽  
Multiple Sclerosis Patients

Abstract Background Alemtuzumab is an effective disease-modifying therapy (DMT) for highly active multiple sclerosis (MS). However, safety concerns limit its use in clinical practice. Objectives To evaluate the safety of alemtuzumab in a nationwide cohort of Finnish MS patients. Methods In this retrospective case series study, we analyzed the data of all but two MS patients who had received alemtuzumab in Finland until 2019. Data were systematically collected from patient files. Results Altogether 121 patients were identified, most of whom had received previous DMTs (82.6%). Median follow-up time after treatment initiation was 30.3 months and exceeded 24 months in 78 patients. Infusion-associated reactions (IARs) were observed in 84.3%, 57.3%, and 57.1% of patients during alemtuzumab courses 1–3, respectively. Serious adverse events (SAEs) were observed in 32.2% of patients, serious IARs in 12.4% of patients, and SAEs other than IARs in 23.1% of patients. Autoimmune adverse events were observed in 30.6% of patients. One patient died of hemophagocytic lymphohistiocytosis, and one patient died of pneumonia. A previously unreported case of thrombotic thrombocytopenic purpura was documented. Conclusions SAEs were more frequent in the present cohort than in previous studies. Even though alemtuzumab is a highly effective therapy for MS, vigorous monitoring with a long enough follow-up time is advised.

Serum albumin and total lymphocyte count as predictors of outcome in hip fractures

2010 ◽  
Vol 29 (1) ◽  
pp. 89-93 ◽  
Author(s):  
Brendan J. O'Daly ◽  
James C. Walsh ◽  
John F. Quinlan ◽  
Gavin A. Falk ◽  
Robert Stapleton ◽  
...  
Keyword(s):  
Serum Albumin ◽  
Hip Fractures ◽  
Lymphocyte Count ◽  
Total Lymphocyte Count ◽  
Predictors Of Outcome ◽  
Total Lymphocyte

scholarly journals Perbandingan Efek Pemberian Emulsi Kedelai dan Emulsi Tempe Terhadap Hitung Limfosit Total pada Tikus Putih yang Telah Diberi Prednison

2017 ◽  
Vol 5 (1) ◽  
pp. 56
Author(s):  
Rizka Bekti Nurcahyani ◽  
Imelda T Pardede ◽  
Huriatul Masdar
Keyword(s):  
Lymphocyte Count ◽  
Total Lymphocyte Count ◽  
Distilled Water ◽  
Adequate Nutrition ◽  
White Rats ◽  
Total Lymphocyte ◽  
Significant Difference ◽  
Group A ◽  
Group B

Adequate nutrition is one of important factors in immunodeficiency repairment. Soybean and tempeh contains proteins,zinc, ferrum, vitamins and isoflavon. Fermentation in tempeh makes it having better nutrients digestion and absorptionthan soybean. The objective of this study was to compare the effects of soy and tempeh emulsions on total lymphocytecount in rats treated with prednisone. The test was done on 24 male white rats divided into four groups. Group A wasgiven distilled water and group B, C and D had prednisone 2.5 mg/day for 6 days. After that, group A and B werecontinued having distilled water while groups C or D was fed with soy or tempeh emulsion 0.71 mL/day for 10 days,respectively. The results shown that soy and tempeh emulsion could increase total lymphocyte count significantly (p <0,05) but there was no significant difference of total lymphocyte count between soy and tempeh emulsion groups (p >0,05).

scholarly journals Low serum albumin and total lymphocyte count as predictors of 30 day hospital readmission in patients 65 years of age or older

2015 ◽  
Author(s):  
Robert Robinson
Keyword(s):  
Risk Factor ◽  
Serum Albumin ◽  
Hospital Readmission ◽  
Lymphocyte Count ◽  
Protein Energy Malnutrition ◽  
Total Lymphocyte Count ◽  
Total Lymphocyte ◽  
Protein Energy ◽  
Patients At Risk ◽  
Low Serum

Introduction: Hospital readmission within 30 days of discharge is a target for health care cost savings through the medicare Value Based Purchasing initiative. Because of this focus, hospitals and health systems are investing considerable resources into the identification of patients at risk of hospital readmission and designing interventions to reduce the rate of hospital readmission. Malnutrition is a known risk factor for hospital readmission. Materials and Methods: All medical patients 65 years of age or older discharged from Memorial Medical Center from January 1, 2012 to March 31, 2012 who had a determination of serum albumin level and total lymphocyte count on hospital admission were studied retrospectively. Admission serum albumin levels and total lymphocyte counts were used to classify the nutritional status of all patients in the study. Patients with a serum albumin less than 3.5 grams/dL and/or a TLC less than 1,500 cells per mm3 were classified as having protein energy malnutrition. The primary outcome investigated in this study was hospital readmission for any reason within 30 days of discharge. Results: The study population included 1,683 hospital discharges with an average age of 79 years. The majority of the patients were female (55.9%) and had a DRG weight of 1.22 (0.68). 219 patients (13%) were readmitted within 30 days of hospital discharge. Protein energy malnutrition was common in this population. Low albumin was found in 973 (58%) patients and a low TLC was found in 1,152 (68%) patients. Low albumin and low TLC was found in 709 (42%) of patients. Kaplan-Meier analysis shows any laboratory evidence of PEM is a significant (p < 0.001) predictor of hospital readmission. Low serum albumin (p < 0.001) and TLC (p = 0.018) show similar trends. Cox proportional-hazards regression analysis showed low serum albumin (Hazard Ratio 3.27, 95% CI: 2.30-4.63) and higher DRG weight (Hazard Ratio 1.19, 95% CI: 1.03-1.38) to be significant independent predictors of hospital readmission within 30 days. Discussion: This study investigated the relationship of PEM to the rate of hospital readmission within 30 days of discharge in patients 65 years of age or older. These results indicate that laboratory markers of PEM can identify patients at risk of hospital readmission within 30 days of discharge. This risk determination is simple and identifies a potentially modifiable risk factor for readmission: protein energy malnutrition.

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