scholarly journals COVID MED - An Early Pandemic Trial of Losartan for Hospitalized COVID-19 Patients

2022 ◽  
Author(s):  
Daniel Freilich ◽  
Jennifer Victory ◽  
Paul Jenkins ◽  
James Wheeler ◽  
G Matthew Vail ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Standard Care ◽  
Potential Benefit ◽  
University Of Minnesota ◽  
Early Stopping ◽  
Improve Outcome ◽  
Combined Control ◽  
Report Data ◽  
To Receive ◽  
Safety Signals

Background ACEi/ARB medications have been hypothesized to have potential benefit in COVID-19. Despite concern for increased ACE-2 expression in some animal models, preclinical and observational-retrospective and uncontrolled trials suggested possible benefit. Two RCTs of the ARB losartan from University of Minnesota showed no benefit yet safety signals for losartan in outpatient and hospitalized COVID-19 patients. COVID MED, started early in the pandemic, also assessed losartan in a RCT in hospitalized patients with COVID-19. Methods COVID MED was quadruple-blinded, placebo-controlled, multicenter randomized clinical trial (RCT). Hospitalized COVID-19 patients were randomized to receive standard care and hydroxychloroquine, lopinavir/ritonavir, losartan, or placebo. Hydroxychloroquine and lopinavir/ritonavir arms were discontinued after RCTs showed no benefit. We report data from the losartan arm compared to combined (lopinavir-ritonavir and placebo) and prespecified placebo-only controls. The primary endpoint was the NCOSS slope of change. Slow enrollment prompted early stopping. Results Of 432 screened patients, 14 were enrolled (3.5%), 9 received losartan and 5 combined control (lopinavir/ritonavir [N=2], placebo [N=3]); 1 hydroxychloroquine arm patient was excluded. Most baseline parameters were balanced. Treatment with losartan was not associated with a difference in NCOSS slope of change in comparison with combined control (p=0.4) or placebo-only control (p=0.05) (trend favoring placebo). 60-day mortality and overall AE and SAE rates were numerically but not significantly higher with losartan. Conclusions In this small blinded RCT in hospitalized COVID-19 patients, losartan did not improve outcome vs. control comparisons and was associated with adverse safety signals.

Overall survival (OS) in patients (pts) with advanced breast cancer (ABC) with visceral metastases (mets), including those with liver mets, treated with ribociclib (RIB) plus endocrine therapy (ET) in the MONALEESA (ML) -3 and -7 trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 1054-1054 ◽  
Author(s):  
Denise A. Yardley ◽  
Arnd Nusch ◽  
Yoon Sim Yap ◽  
Gabe S. Sonke ◽  
Thomas Bachelot ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Poor Prognosis ◽  
Phase Iii ◽  
Second Line ◽  
Early Relapse ◽  
Visceral Metastases ◽  
To Receive ◽  
Clinical Trial Information ◽  
Safety Signals

1054 Background: In the Phase III ML-3 (NCT02422615) and ML-7 (NCT02278120) trials, RIB + ET demonstrated a significant OS benefit (ML-3: HR, 0.72, P = 0.00455; ML-7: HR, 0.71, P = 0.00973) over placebo (PBO) + ET in pts with HR+/HER2- ABC (Im et al. N Engl J Med. 2019; Slamon et al. N Engl J Med. 2019). The presence of visceral mets generally portends a poor prognosis, which is especially poor in pts with liver mets (He et al. Ann Oncol. 2019). Here we report OS in pts with visceral mets with a focus on those with liver mets in ML-3 and ML-7. Methods: In ML-3, postmenopausal pts were randomized 2:1 to receive RIB + fulvestrant (FUL) or PBO + FUL as first- (1L) or second-line (2L) treatment. In ML-7, premenopausal pts were randomized 1:1 to receive RIB + ET or PBO + ET (this analysis included only pts who received an NSAI as ET partner to match approved indication). Results: Visceral mets were identified in 293 pts (60.5%) in the RIB arm and 147 (60.7%) in the PBO arm in ML-3 and 150 (44.8%) and 142 pts (42.1%), respectively, in ML-7. In ML-3, the median age of pts with visceral mets was 63 and 65 years in the RIB and PBO arms, and in ML-7 it was 42.5 and 45.0 years, respectively. In ML-3, 214 pts with visceral mets received 1L therapy (RIB, n = 137; PBO, n = 77), while 219 pts received 2L therapy or had early relapse (RIB, n = 151; PBO, n = 68). Lung and liver were the most common sites of visceral mets for pts in ML-3 (49.8% and 44.8%, respectively) and ML-7 (51.4% and 58.2%, respectively). OS HRs in pts with visceral mets were consistent with the benefit in the overall pt populations and suggested a particularly substantial OS benefit in pts with liver mets (HR for liver mets group in ML-3, 0.629 [95% CI, 0.421-0.942]; HR in ML-7, 0.531 [95% CI, 0.321-0.877]; Table). No new safety signals were observed. Conclusions: Approximately half of the pts in ML-3 and ML-7 had visceral mets. The OS data in these pts are consistent with the benefit observed with RIB in the overall populations of each trial. In pts with liver mets, a group with an especially poor prognosis, RIB + ET demonstrated a substantial OS benefit compared with PBO + ET. Clinical trial information: NCT02422615; NCT02278120 . [Table: see text]

Telemedicine for Patients with Inflammatory Bowel Disease (TELE-IBD) Clinical Trial: Qualitative Assessment of Participants’ Perceptions of the TELE-IBD Intervention (Preprint)

2019 ◽  
Author(s):  
Charlene C Quinn ◽  
Sarah Chard ◽  
Erin G Roth ◽  
J. Kevin Eckert ◽  
Katharine M Russman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Disease Activity ◽  
Remote Monitoring ◽  
Standard Care ◽  
Disease Process ◽  
The United States ◽  
Qualitative Assessment ◽  
Structured Interviews ◽  
Treatment Groups ◽  
Inflammatory Bowel

BACKGROUND Inflammatory bowel diseases (IBD), comprising Crohn’s disease and ulcerative colitis, affects 1 to 3 million people in the United States. Telemedicine has shown promise in IBD. The objective of the parent study, TELE-IBD, was to compare disease activity and quality of life (QoL) in a one-year randomized clinical trial of IBD patients receiving telemedicine versus standard care. Treatment groups experienced improvements in disease activity and QoL but there was not significant differences between groups. Study adherence to the text-based intervention was less than the 80% of the targeted goal. OBJECTIVE To understand adherence to remote monitoring, the goal of this qualitative assessment was to obtain TELE-IBD trial participants’ perceptions of the TELE-IBD system, including their recommendations for future TELE-IBD monitoring. METHODS In the parent study, patients attending three tertiary referral centers with worsening IBD symptoms in the previous two years were eligible for randomization to remote monitoring via texts every other week (EOW), weekly (W) or standard care. Participants (n=348) were evenly enrolled in the treatment groups and 259 (74.4%) completed the study. For this study, a purposive sample of adherent (N=15) and non-adherent (N=14) patients was drawn from the TELE-IBD trial population. Adherence was defined as the completion of 80% or more of the W or EOW self-assessments. Semi-structured interviews conducted by phone surveyed 1) the strengths and benefits of TELE-IBD; 2) challenges associated with using TELE-IBD; and 3) how to improve the TELE-IBD intervention. Interviews were recorded, professionally transcribed, and coded based on a priori concepts and emergent themes with the aid of ATLAS.ti qualitative data analysis software. RESULTS Participants' discussions centered on three elements of the intervention: 1) self-assessment questions, 2) action plans, and 3) educational messages. Participants also commented on: text-based platform, depression and adherence, TELE-IBD system in place of office visit, and their recommendations for future TELE-IBD systems. Adherent and non-adherent participants prefer a flexible system that is personalized, including targeted education messages, and they perceive TELE-IBD as effective in facilitating IBD self-management. CONCLUSIONS Participants identified clear benefits to the TELE-IBD system, including obtaining a better understanding of the disease process, monitoring their symptoms, and feeling connected to their health care provider. Participants' perceptions obtained in this qualitative study will assist in improving the TELE-IBD system to be more responsive to patients with IBD. CLINICALTRIAL NCT01692743

scholarly journals Residual gastric volume evaluation with ultrasonography after ingestion of carbohydrate- or carbohydrate plus glutamine-enriched beverages: a randomized, crossover clinical trial with healthy volunteers

2017 ◽  
Vol 54 (1) ◽  
pp. 33-36 ◽  
Author(s):  
Paulo Cesar GOMES ◽  
Cervantes CAPOROSSI ◽  
Jose Eduardo AGUILAR-NASCIMENTO ◽  
Ageo Mario Candido da SILVA ◽  
Viviane Maeve Tavares de ARAUJO
Keyword(s):  
Clinical Trial ◽  
Healthy Volunteers ◽  
Postoperative Recovery ◽  
Gastric Volume ◽  
Safe Procedure ◽  
Abdominal Ultrasonography ◽  
Residual Gastric Volume ◽  
Potential Benefits ◽  
The Mean ◽  
To Receive

ABSTRACT BACKGROUND Abbreviation of preoperative fasting to 2 hours with maltodextrin (CHO)-enriched beverage is a safe procedure and may enhance postoperative recovery. Addition of glutamine (GLN) to CHO beverages may include potential benefits to the metabolism. However, by adding a nitrogenous source to CHO beverages, gastric emptying may be delayed and increase the risk of bronchoaspiration during anesthesia. OBJECTIVE In this study of safety, we aimed at investigating the residual gastric volume (RGV) 2 hours after the intake of either CHO beverage alone or CHO beverage combined with GLN. METHODS We performed a randomized, crossover clinical trial. We assessed RGV by means of abdominal ultrasonography (US) in 20 healthy volunteers (10 males and 10 females) after an overnight fast of 8 hours. Then, they were randomized to receive 600 mL (400 mL immediately after US followed by another 200 mL 2 hours afterwards) of either CHO (12.5% maltodextrin) or CHO-GLN (12.5% maltodextrin plus 15 g GLN). Two sequential US evaluations were done at 120 and 180 minutes after ingestion of the second dose. The interval of time between ingestion of the two types of beverages was 2 weeks. RESULTS The mean (SD) RGV observed after 8 hours fasting (13.56±13.25 mL) did not statistically differ (P>0.05) from the RGV observed after ingesting CHO beverage at both 120 (16.32±11.78 mL) and 180 minutes (14.60±10.39 mL). The RGV obtained at 120 (15.63±18.83 mL) and 180 (13.65±10.27 mL) minutes after CHO-GLN beverage also was not significantly different from the fasting condition. CONCLUSION The RGV at 120 and 180 minutes after ingestion of CHO beverage combined with GLN is similar to that observed after an overnight fast.

Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma (ccRCC): Results from 42-month follow-up of KEYNOTE-426.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4500-4500
Author(s):  
Brian I. Rini ◽  
Elizabeth R. Plimack ◽  
Viktor Stus ◽  
Tom Waddell ◽  
Rustem Gafanov ◽  
...  
Keyword(s):  
Interim Analysis ◽  
Final Analysis ◽  
Similar Proportion ◽  
First Line ◽  
Cell Renal Cell Carcinoma ◽  
Superior Efficacy ◽  
Treatment Naïve ◽  
To Receive ◽  
Safety Signals

4500 Background: In the first interim analysis of the randomized, multicenter, open-label, phase 3 KEYNOTE-426 study (NCT02853331), treatment with pembro + axi significantly improved OS, PFS, and ORR vs sunitinib monotherapy in treatment-naive advanced ccRCC. Extended follow-up (median, 30.6 mo) continued to demonstrate the superior efficacy of pembro + axi vs sunitinib monotherapy in this patient population. Here, we present the results of the prespecified final analysis with 42.8-mo median follow-up. Methods: Treatment-naive patients (pts) with advanced ccRCC, KPS ≥70%, and measurable disease (RECIST v1.1) were randomly assigned 1:1 to receive pembro 200 mg IV Q3W for up to 35 doses + axi 5 mg orally BID or sunitinib 50 mg orally QD on a 4-wk on/2-wk off schedule until progression, intolerable toxicity, or withdrawal. Randomization was stratified by IMDC risk (favorable vs intermediate vs poor) and geographic region (North America vs Western Europe vs Rest of World). Dual primary endpoints were OS and PFS. Secondary endpoints were ORR, DOR, and safety. The protocol-specified final analysis was based on a target of 404 OS events. No formal hypothesis testing was performed because all efficacy endpoints were met previously at the first interim analysis; nominal P values are reported. Results: Overall, 861 pts were randomly assigned to receive pembro + axi (n=432) or sunitinib (n=429). Median duration of follow-up, defined as time from randomization to the database cutoff date, was 42.8 mo (range, 35.6-50.6). At data cutoff, 418 pts had died: 193 (44.7%) of 432 pts in the pembro + axi arm vs 225 (52.4%) of 429 pts in the sunitinib arm. Compared with sunitinib, pembro + axi improved OS (median: 45.7 vs 40.1 mo; HR, 0.73 [95% CI, 0.60-0.88]; P<0.001) and PFS (median: 15.7 vs 11.1 mo; HR, 0.68 [95% CI, 0.58-0.80]; P<0.0001). The 42-mo OS rate was 57.5% with pembro + axi vs 48.5% with sunitinib; the 42-mo PFS rate was 25.1% with pembro + axi vs 10.6% with sunitinib. For pembro + axi vs sunitinib, ORR was 60.4% vs 39.6% ( P<0.0001); CR rate was 10.0% vs 3.5%; median DOR was 23.6 mo (range 1.4+ to 43.4+) vs 15.3 mo (range, 2.3-42.8+). Subsequent anticancer therapy was administered to 47.2% of pts in pembro + axi arm vs 65.5% of pts in sunitinib arm. Although a similar proportion of pts in each arm received VEGF/VEGFR inhibitors, only 10.2% of pts in the pembro + axi arm received subsequent treatment with a PD-1/L1 inhibitor compared to 48.7% of pts in the sunitinib arm. No new safety signals were observed. Conclusions: With a median follow-up of 42.8 mo, this is the longest follow-up of an anti-PD–1/L1 immunotherapy combined with a VEGF/VEGFR inhibitor for first-line RCC. These results show that pembro + axi continues to demonstrate superior efficacy over sunitinib with respect to OS, PFS, and ORR, with no new safety signals. Clinical trial information: NCT02853331.

Solumedrol Treatment for Severe Sepsis in Humans with a Blunted Adrenocorticotropic Hormone-Cortisol Response: A Prospective Randomized Double-Blind Placebo-Controlled Pilot Clinical Trial

2021 ◽  
pp. 088506662110388
Author(s):  
Divya Birudaraju ◽  
Sajad Hamal ◽  
John A. Tayek
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Adrenocorticotropic Hormone ◽  
Serum Cortisol ◽  
High Dose ◽  
Cortisol Response ◽  
Acth Stimulation ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive

Purpose To test the benefits of Solumedrol treatment in sepsis patients with a blunted adrenocorticotropic hormone (ACTH)-cortisol response (delta <13 µg/dL) with regard to the number of days on ventilator, days on intravenous blood pressure support, length of time in an intensive care unit (ICU), 14-day mortality, and 28-day mortality. The trial was prospective, randomized, and double-blind. As part of a larger sepsis trial, 54 patients with sepsis had an intravenous ACTH stimulation test using 250 µg of ACTH, and serum cortisol was measured at times 0, 30, and 60 min. Eleven patients failed to increase their cortisol concentration above 19.9 µg/dL and were excluded from the clinical trial as they were considered to have adrenal insufficiency. The remaining 43 patients had a baseline cortisol of 32 ± 1 µg/dL increased to 38 ± 3 µg/dL at 30 min and 40 ± 3 at 60 min. All cortisol responses were <12.9 µg/dL between time 0 and time 60, which is defined as a blunted cortisol response to intravenous ACTH administration. Twenty-one were randomized to receive 20 mg of intravenous Solumedrol and 22 were randomized to receive a matching placebo every 8 h for 7-days. There was no significant difference between the two randomized groups. Data analysis was carried out bya two-tailed test and P < .05 as significant. Results Results: The mean age was 51 ± 2 (mean ± SEM) with 61% female. Groups were well matched with regard to APACHE III score in Solumedrol versus placebo (59 ± 6 vs 59 ± 6), white blood cell count (18.8 ± 2.2 vs 18.6 ± 2.6), and incidence of bacteremia (29 vs 39%). The 28-day mortality rate was reduced in the Solumedrol treated arm (43 ± 11 vs 73 ± 10%; P < .05). There was no change in days in ICU, days on blood pressure agents, or days on ventilator. Seven days of high-dose intravenous Solumedrol treatment (20 mg every 8 h) in patients with a blunted cortisol response to ACTH was associated with an improved 28-day survival. This small study suggests that an inability to increase endogenous cortisol production in patients with sepsis who are then provided steroid treatment could improve survival.

scholarly journals Effect of Red Wine Intake on Serum and Salivary Melatonin Levels: A Randomized, Placebo-Controlled Clinical Trial

Molecules ◽  
2018 ◽  
Vol 23 (10) ◽  
pp. 2474 ◽  
Author(s):  
Elena Varoni ◽  
Rita Paroni ◽  
Jacopo Antognetti ◽  
Giovanni Lodi ◽  
Andrea Sardella ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Healthy Volunteers ◽  
Red Wine ◽  
Statistical Significance ◽  
Serum Levels ◽  
Controlled Clinical Trial ◽  
Salivary Melatonin ◽  
The One ◽  
To Receive

Melatonin (MLT) is a recently discovered phytochemical in wine, but its influence on physiological MLT levels is still unknown. This study aimed at evaluating variations, in serum and saliva, of MLT concentrations after the intake of MLT-enriched red wine. Twelve healthy volunteers were recruited to receive 125 mL of red wine naturally lacking of MLT (placebo, PLC), or the same wine enriched with MLT (MLT+). A physiological steady decline of serum MLT was observed from baseline up to 90 min, for both wines. After PLC intake, the decrease was significantly faster than the one occurring after MLT+ wine, which thus delayed the drop down of serum MLT with a plateau at 30–60 min. Salivary MLT levels slightly peaked at 45 min after MLT+ wine intake, without statistical significance. Therefore, the intake of a glass of MLT-enriched red wine changed serum levels of the indoleamine, supporting the role of wine MLT in counteracting the physiological decline of the hormone into the bloodstream.

scholarly journals Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial

2020 ◽  
Author(s):  
Cristina Avendano-Sola ◽  
Antonio Ramos-Martinez ◽  
Elena Munez-Rubio ◽  
Belen Ruiz-Antoran ◽  
Rosa Malo de Molina ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Randomized Clinical Trial ◽  
Strong Dependence ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Control Group ◽  
Standard Of Care Treatment ◽  
And Control ◽  
To Receive

Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).

scholarly journals Prospective, Multicentric Phase II Randomized Trial Comparing the Efficacy of Methotrexate or Cyclophosphamide in Large Granular Lymphocytic Leukemia: A French National Study. Report on the Interim Analysis

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1545-1545 ◽  
Author(s):  
Thierry Lamy ◽  
Cedric Pastoret ◽  
Roch Houot ◽  
Loic Ysebaert ◽  
Mathilde Hunault ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Research Funding ◽  
Sequential Analysis ◽  
Severe Neutropenia ◽  
National Study ◽  
Sufficient Information ◽  
Transfusion Requirements ◽  
Stat3 Mutation ◽  
To Receive ◽  
Lgl Leukemia

Introduction Large granular lymphocyte (LGL) leukemia is characterized by a clonal expansion of CD3+ cytotoxic T or CD3- NK cells. Prominent clinical features include neutropenia, anemia and autoimmune-associated diseases such as rheumatoid arthritis (RA). Although the disease is usually chronic and indolent, some patients may be symptomatic and require treatment. No standard therapy has been established due to the absence of prospective clinical trials. So far, low dose methotrexate, oral cyclophosphamide, and cyclosporine represent the 3 main options for initial therapy. In 2014, we launched a prospective clinical trial comparing methotrexate to cyclophosphamide in previously-untreated patients with LGL leukemia in need of treatment. Patients and methods The study was designed as a multicentric, national, open label, randomized, controlled trial on two parallel groups, comparing methotrexate and cyclophosphamide. Patients were included if they had at least one of the following indications of treatment: isolated severe neutropenia (ANC &lt;0.5x109/L) or neutropenia (ANC &lt;1.5x109/L) with infections, anemia requiring transfusions or symptomatic anemia, associated complications such as systemic diseases or auto-immune diseases resistant to steroids and/or immunomodulating agents (colchicin, disulone, hydrochloroquine). They were randomly assigned to receive either methotrexate (10 mg/m²/w) or cyclophosphamide (100 mg/d) for 4 months. Responders at M4 continued with the same treatment until M12 (cyclophosphamide was then delivered at 50 mg/d). Non-responders at M4 were randomly assigned to receive either cyclosporine (3 mg/kg/d) or the drug which had not been administered at the first randomization (methotrexate or cyclophosphamide). Response was assessed using previously published criteria (Lamy T, Blood 123:1182, 2014). Complete response (CR) was defined as a normalization of clinical exam (disappearance of splenomegaly or associated autoimmune symptoms) and a complete normalization of blood counts. Partial response (PR) was defined as an improvement in blood counts which did not meet criteria for complete remission (e.g., ANC &gt;0.5x109/L or decrease of transfusion requirements). Treatment failure was defined as no response or any response which did not meet the above-mentioned criteria within four months after the beginning of treatment. To stop the trial as soon as sufficient information was collected, a sequential analysis was planned each time 20 patients were included and evaluated using the triangular test (Sébille V, Bellissant E. Fundam Clin Pharmacol. 2003;17(5):505-16). The primary endpoint was the hematological CR rate evaluated at M4 (binary endpoint). Secondary endpoints were overall response rate (ORR) at M4, M8 and M12, time to relapse. For non-responders at M4, cyclosporine was compared to the treatment which had not been administered during the first phase. Results From Nov 2013 to July 2019, 99 patients met inclusion criteria among which 96 were randomized. The baseline characteristics of these patients are shown in Table1. STAT3 mutation was observed 52% of cases. After the 4th sequential analysis performed on the first 80 patients evaluable for response at M4, the sample path remained in the continuation region of the triangular test. Thus, the trial has to be continued. At M4, 13 patients were in CR (16.3%) and 29 patients were in PR (36.3%), ORR was 52.6%, 36 patients were considered as refractory and underwent a second randomization: 18 patients received cyclosporine and 17 received methotrexate or cyclophosphamide. Conclusions This first prospective randomized clinical trial in LGL leukemia shows that the CR after first line therapy using either methotrexate or cyclophosphamide is relatively low (&lt; 20%). Recruitment is still ongoing to assess if there is a difference in terms of response between the two drugs. Predictive biomarkers of response will be presented at the meeting. Regarding a 52% of incidence of Stat3 mutation (higher than that previously published), Jak/Stat targeted therapy should be prospectively evaluated in this disease. Disclosures Houot: Bristol Myers Squibb: Honoraria; Merck Sharp Dohme: Honoraria. Gyan:Pfizer: Honoraria. Feugier:janssen: Honoraria, Research Funding, Speakers Bureau; abbvie: Honoraria, Research Funding, Speakers Bureau; gilead: Honoraria, Research Funding, Speakers Bureau; roche: Honoraria, Research Funding, Speakers Bureau.

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