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https://www.readbyqxmd.com/read/29333561/pharmacokinetics-of-the-b-cell-lymphoma-2-bcl-2-inhibitor-venetoclax-in-female-subjects-with-systemic-lupus-erythematosus
#1
Mukul Minocha, Jiewei Zeng, Jeroen K Medema, Ahmed A Othman
BACKGROUND AND OBJECTIVE: Venetoclax is an oral selective Bcl-2 inhibitor approved for the treatment of patients with chronic lymphocytic leukemia with 17p deletion. Mechanistic and preclinical evidence warranted evaluation of venetoclax for the treatment of systemic lupus erythematosus (SLE). This work characterized the pharmacokinetics of venetoclax in female subjects with SLE. METHODS: Single (10-500 mg) and multiple (30-600 mg) escalating doses of venetoclax or matching placebo were evaluated using randomized, double-blind, placebo-controlled designs (6 active and 2 placebo per dose with 73 unique SLE patients enrolled, 25 of whom enrolled twice)...
January 15, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29331663/a-multi-center-randomized-trial-to-evaluate-hematologic-toxicities-after-hyperthermic-intraperitoneal-chemotherapy-with-oxaliplatin-or-mitomycin-in-patients-with-appendiceal-tumors
#2
Edward A Levine, Konstantinos I Votanopoulos, Perry Shen, Greg Russell, Joyce Fenstermaker, Paul Mansfield, David Bartlett, John H Stewart
BACKGROUND: Appendiceal cancer is a rare disease, which has proven difficult to study in prospective trials. Cytoreductive surgery with HIPEC is an established therapy for peritoneal dissemination from appendiceal cancer. The optimal chemotherapeutic agent to use in the HIPEC is not clear. Mitomycin has long been the utilized, however our previous phase I experience, and European retrospective studies suggest oxaliplatin as an alternative. Therefore, we initiated a multicenter randomized trial to compare mitomycin to oxaliplatin HIPEC for appendiceal cancer...
January 10, 2018: Journal of the American College of Surgeons
https://www.readbyqxmd.com/read/29325521/adjuvant-treatment-of-resectable-biliary-tract-cancer-with-cisplatin-plus-gemcitabine-a-prospective-single-center-phase-ii-study
#3
Alexander R Siebenhüner, Heike Seifert, Helga Bachmann, Burkhardt Seifert, Thomas Winder, Jonas Feilchenfeldt, Stefan Breitenstein, Pierre-Alain Clavien, Roger Stupp, Alexander Knuth, Bernhard Pestalozzi, Panagiotis Samaras
BACKGROUND: Biliary tract cancer (BTC) is a dismal disease, even after curative intent surgery. We conducted this prospective, non-randomized phase II study to evaluate the feasibility and efficacy of cisplatin and gemcitabine as adjuvant treatment in patients with resected BTC. METHODS: Patients initially received gemcitabine 1000 mg/m2 alone on days 1, 8 and 15 every 28-days for a total of six cycles (single agent cohort), and after protocol amendment a combination therapy with gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2 on days 1 and 8 was administered every 21 days for a total of eight cycles (combined regimen cohort)...
January 11, 2018: BMC Cancer
https://www.readbyqxmd.com/read/29322849/safety-profile-of-lenalidomide-in-patients-with-lower-risk-myelodysplastic-syndromes-without-del-5q-results-of-a-phase-3-trial
#4
Antonio Almeida, Pierre Fenaux, Guillermo Garcia-Manero, Stuart L Goldberg, Stefanie Gröpper, Anna Jonasova, Norbert Vey, Carmen Castaneda, Jianhua Zhong, C L Beach, Valeria Santini
The safety profile of lenalidomide use in lower-risk myelodysplastic syndromes (MDS) patients with del(5q) is well-established, but less is known in non-del(5q) patients. We provide safety data from a randomized, phase 3 trial evaluating lenalidomide in 239 patients with lower-risk non-del(5q) MDS ineligible/refractory to erythropoiesis-stimulating agents (ESAs). Compared with placebo, lenalidomide was associated with a higher incidence of grade 3-4 treatment-emergent adverse events (TEAEs; 86% vs. 44%), but not risk of infection (p = ...
January 11, 2018: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/29320913/a-phase-2-study-of-rituximab-cyclophosphamide-bortezomib-and-dexamethasone-r-cybord-in-relapsed-low-grade-and-mantle-cell-lymphoma
#5
Mohamad Bassam Sonbol, Talal Hilal, Amylou C Dueck, Allison C Rosenthal, Christopher R Conley, Heidi E Kosiorek, Brenda F Ginos, Katherine M Gano, Craig S Nichols, Jose F Leis, Patrick B Johnston, Thomas M Habermann, Donald W Northfelt, Peter Leif Bergsagel, David J Inwards, Thomas E Witzig, Stephen M Ansell, Craig B Reeder
In this phase 2 trial, we sought to evaluate the efficacy and safety of rituximab, cyclophosphamide, bortezomib, and dexamethasone (R-CyBorD) in patients with low-grade NHL. The regimen included rituximab on day 1 with weekly cyclophosphamide, dexamethasone, and bortezomib 1.3 mg/m2 IV in a 28-day cycle. Twenty one patients were enrolled on the study. Median age was 69 years (range 51-80) and 17 (81%) patients had two or more prior treatments. Histologies included FL (n = 8), MCL (n = 8), and LPL/WM (n = 5)...
January 10, 2018: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/29320771/perianal-infections-in-the-phase-before-engraftment-after-allogeneic-hematopoietic-stem-cell-transplantations-a-study-of-the-incidence-risk-factors-and-clinical-outcomes
#6
Xiao-Dong Mo, Xia Yan, Wei Hu, Xiao-Hui Zhang, Lan-Ping Xu, Yu Wang, Xiao-Dong Xu, Lin-Nan Wang, Xin-Xin He, Chen-Hua Yan, Huan Chen, Yu-Hong Chen, Kai-Yan Liu, Xiao-Jun Huang
In this study, we aimed to investigate the incidence, risk factors, and clinical outcomes of perianal infections during the pre-engraftment phase after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Consecutive patients who underwent non-T-cell-depleted allo-HSCT at the Peking University Institute of Hematology from January 1 to December 31, 2016 were enrolled (n = 646). Ninety-nine patients were found to have perianal infections during the pre-engraftment phase, and 80 were found to have neutropenia on perianal infection diagnosis...
January 11, 2018: Acta Haematologica
https://www.readbyqxmd.com/read/29319498/safety-and-tolerance-of-cidofovir-as-a-2-gel-for-local-application-in-high-grade-cervical-intraepithelial-neoplasia-a-phase-1-investigation
#7
Michel Bossens, Maud Jost, Catherine Van Pachterbeke, Viviane De Maertelaer, Philippe Simon, Francis Frankenne, Philippe Hubert, Brigitte Evrard, Robert Snoeck
OBJECTIVES: The primary objective was to evaluate the safety and local tolerance of a topical 2% (w/w) cidofovir gel, applied directly to the cervices of women with high-grade cervical intraepithelial neoplasia (CIN 2+). The secondary objective was to evaluate the pharmacokinetics of cidofovir during the treatment. MATERIALS AND METHODS: Nine women with CIN 2+, were treated with a course of 3 g of cidofovir gel, applied locally once per week for 3 weeks in total (9 g)...
January 10, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29317395/the-role-of-elotuzumab-in-the-treatment-of-relapsed-or-refractory-multiple-myeloma
#8
REVIEW
Jill M Comeau, Katherine Kelly, Gary W Jean
PURPOSE: The pharmacology, pharmacokinetics, clinical efficacy and safety, cost, and place in therapy of elotuzumab for treatment of relapsed or refractory multiple myeloma (MM) are reviewed. SUMMARY: Elotuzumab is a humanized monoclonal antibody that targets the signaling lymphocytic activation molecule (SLAM) protein SLAMF7 and facilitates an antibody-dependent cellular cytotoxicity interaction between myeloma cells and natural killer cells. Elotuzumab has U.S...
January 15, 2018: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/29316288/carboplatin-plus-pemetrexed-for-the-elderly-incurable-chemo-naive-nonsquamous-non-small-cell-lung-cancer-meta-analysis
#9
Masaru Ito, Nobuyuki Horita, Akimichi Nagashima, Takeshi Kaneko
AIM: In some developed countries, a proportion of nonsquamous non-small cell lung cancer (NSq NSCLC) patients are aged over 70 years when they are diagnosed. However, evidence of lung cancer chemotherapy usually comes from randomized controlled trials that only recruit younger patients with good performance status. In daily practice, less-toxic carboplatin + pemetrexed regimen is often used for elderly patients, although this regimen is not sufficiently supported by rigid evidence for elderly cases...
January 8, 2018: Asia-Pacific Journal of Clinical Oncology
https://www.readbyqxmd.com/read/29315079/safety-and-tolerability-of-spermidine-supplementation-in-mice-and-older-adults-with-subjective-cognitive-decline
#10
Claudia Schwarz, Slaven Stekovic, Miranka Wirth, Gloria Benson, Philipp Royer, Stephan J Sigrist, Thomas Pieber, Christopher Dammbrueck, Christoph Magnes, Tobias Eisenberg, Tobias Pendl, Jens Bohlken, Theresa Köbe, Frank Madeo, Agnes Flöel
Supplementation of spermidine, an autophagy-inducing agent, has been shown to protect against neurodegeneration and cognitive decline in aged animal models. The present translational study aimed to determine safety and tolerability of a wheat germ extract containing enhanced spermidine concentrations. In a preclinical toxicity study, supplementation of spermidine using this extract did not result in morbidities or changes in behavior in BALBc/Rj mice during the 28-days repeated-dose tolerance study. Post mortem examination of the mice organs showed no increase in tumorigenic and fibrotic events...
January 8, 2018: Aging
https://www.readbyqxmd.com/read/29305630/chronic-myeloid-leukemia-patients-in-tunisia-epidemiology-and-outcome-in-the-imatinib-era-a-multicentric-experience
#11
Raihane Ben Lakhal, Hela Ghedira, Hatem Bellaaj, Yosra Ben Youssef, Samia Menif, Zeineb Manai, Manel Bedoui, Amel Lakhal, Fehmi M'Sadek, Moez Elloumi, Abderrahmane Khélif, Neila Ben Romdhane, Mohamed Adnène Laatiri, Tarek Ben Othmen, Balkis Meddeb
Data are limited in developing countries regarding the clinicopathologic features and response to therapy of chronic myeloid leukemia (CML) in the era of imatinib (IM). The objective of this study is to report on the clinicoepidemiologic features of CML in Tunisia, to evaluate the long-term outcome of patients in chronic (CP) or accelerated phase (AP) treated with IM 400 mg daily as frontline therapy, and to determine imatinib's efficacy and safety. From October 2002 to December 2014, 410 CML patients were treated with IM in six Tunisian departments of hematology...
January 6, 2018: Annals of Hematology
https://www.readbyqxmd.com/read/29305552/venetoclax-for-patients-with-chronic-lymphocytic-leukemia-who-progressed-during-or-after-idelalisib-therapy
#12
Steven Coutre, Michael Choi, Richard R Furman, Herbert Eradat, Leonard Heffner, Jeffrey A Jones, Brenda Chyla, Lang Zhou, Suresh Agarwal, Tina Waskiewicz, Maria Verdugo, Rod A Humerickhouse, Jalaja Potluri, William G Wierda, Matthew S Davids
B-cell receptor pathway inhibitors (BCRi) have transformed treatment for chronic lymphocytic leukemia (CLL); however, efficacy of therapies for patients whose disease is refractory to/relapses after (R/R) BCRi is unknown. Venetoclax is a selective, orally bioavailable BCL-2 inhibitor with activity in patients with CLL, including those who are heavily pretreated or have 17p deletion. This phase 2 study prospectively evaluated venetoclax in patients with R/R CLL after ibrutinib or idelalisib; here we report on patients who received idelalisib as the last BCRi prior to enrollment...
January 5, 2018: Blood
https://www.readbyqxmd.com/read/29299164/xpo1-target-occupancy-measurements-confirm-the-selinexor-recommended-phase-2-dose
#13
Marsha L Crochiere, Stefan Hannus, Kerrin Hansen, Frank Becker, Erkan Baloglu, Margaret Lee, Michael Kauffman, Sharon Shacham, Yosef Landesman
XPO1 (exportin 1) is the main nuclear export protein with over 200 different protein cargos. XPO1 is overexpressed in tumor cells and high levels are correlated with poor prognosis. Selective Inhibitor of Nuclear Export (SINE) compounds block nuclear export by inhibiting XPO1. The first SINE compound, selinexor, shows promising anti-cancer activity across hematological and solid tumors in Phase 2 and 3 clinical trials. The 2nd generation SINE compound KPT-8602 is being evaluated as an anti-cancer agent in a Phase 1 clinical trial...
December 15, 2017: Oncotarget
https://www.readbyqxmd.com/read/29296798/a-phase-2-study-of-panobinostat-with-lenalidomide-and-weekly-dexamethasone-in-myeloma
#14
Ajai Chari, Hearn J Cho, Amishi Dhadwal, Gillian Morgan, Lisa La, Katarzyna Zarychta, Donna Catamero, Erika Florendo, Nadege Stevens, Daniel Verina, Elaine Chan, Violetta Leshchenko, Alessandro Laganà, Deepak Perumal, Anna Huo-Chang Mei, Kaity Tung, Jami Fukui, Sundar Jagannath, Samir Parekh
Phase 3 studies combining histone deacetylase inhibitors with bortezomib were hampered by gastrointestinal (GI) intolerance, which was not observed when combined with immunomodulatory drugs. This study is a single-center phase 2 study of panobinostat with lenalidomide and dexamethasone (FRD). Twenty-seven relapsed multiple myeloma patients were enrolled. Twenty-two patients (81%) were lenalidomide refractory and 9 (33%), 14 (52%), and 7 (26%) were refractory to pomalidomide, bortezomib, and carfilzomib, respectively...
August 22, 2017: Blood Advances
https://www.readbyqxmd.com/read/29290249/a-phase-i-trial-of-afatinib-and-bevacizumab-in-chemo-na%C3%A3-ve-patients-with-advanced-non-small-cell-lung-cancer-harboring-egfr-mutations-okayama-lung-cancer-study-group-trial-1404
#15
Takashi Ninomiya, Naoyuki Nogami, Toshiyuki Kozuki, Daijiro Harada, Toshio Kubo, Kadoaki Ohashi, Shoichi Kuyama, Kenichiro Kudo, Akihiro Bessho, Nobuaki Fukamatsu, Nobukazu Fujimoto, Keisuke Aoe, Takuo Shibayama, Keisuke Sugimoto, Nagio Takigawa, Katsuyuki Hotta, Katsuyuki Kiura
OBJECTIVE: In advanced epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC), treatment with afatinib, a second-generation EGFR-tyrosine kinase inhibitor (TKI), confers a significant survival benefit over platinum-based chemotherapy. The first-generation EGFR-TKIs gefitinib and erlotinib in combination with bevacizumab have improved progression-free survival. We hypothesized that the combination of afatinib with bevacizumab would further improve efficacy, and conducted a phase I trial to test this hypothesis...
January 2018: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/29284479/acacia-hydaspica-r-parker-prevents-doxorubicin-induced-cardiac-injury-by-attenuation-of-oxidative-stress-and-structural-cardiomyocyte-alterations-in-rats
#16
Tayyaba Afsar, Suhail Razak, Khalid Mujasam Batoo, Muhammad Rashid Khan
BACKGROUND: The use of doxorubicin (DOX) an anthracycline antineoplastic agent is withdrawn due to its cardio-toxic side effects. Oxidative stress has been recognized as the primary cause of DOX induced cardiotoxicity. We have investigated whether polyphenol rich ethyl acetate extract of Acacia hydaspica (AHE) can attenuate doxorubicin-induced cardiotoxicity via inhibition of oxidative stress. METHODS: AHE was administered orally to rats once daily for 6 weeks at doses of 200 and 400 mg/kg b...
December 29, 2017: BMC Complementary and Alternative Medicine
https://www.readbyqxmd.com/read/29282890/efficacy-safety-and-pharmacokinetics-of-subcutaneous-azacitidine-in-chinese-patients-with-higher-risk-myelodysplastic-syndromes-results-from-a-multicenter-single-arm-open-label-phase-2-study
#17
Xin Du, Yue-Yun Lai, Zhijian Xiao, Ting Liu, Yu Hu, Aining Sun, Xiao Li, Zhi-Xiang Shen, Jie Jin, Li Yu, Eric Laille, Qian Dong, Stephen Songer, C L Beach
BACKGROUND: Azacitidine safety and efficacy were established in studies of mainly Caucasian patients. Differences in drug metabolism enzymes between Caucasian and East Asian populations prevent extrapolation of drug effects between these groups. This phase 2 study evaluated azacitidine safety, efficacy and pharmacokinetics in patients with higher-risk myelodysplastic syndromes (HR-MDS) in mainland China. METHODS: Patients aged ≥18 years with HR-MDS were to receive subcutaneous azacitidine 75 mg/m2 /day for 7 days per 28-day cycle, for ≥6 cycles...
December 28, 2017: Asia-Pacific Journal of Clinical Oncology
https://www.readbyqxmd.com/read/29280762/brentuximab-vedotin-with-avd-shows-safety-in-the-absence-of-strong-cyp3a4-inhibitors-in-newly-diagnosed-hiv-associated-hodgkin-lymphoma
#18
Paul G Rubinstein, Page C Moore, Michelle A Rudek, David H Henry, Juan C Ramos, Lee Ratner, Erin Reid, Elad Sharon, Ariela Noy
OBJECTIVE: Brentuximab vedotin (BV) is an FDA approved anti-CD30 antibody drug conjugate potently active in Hodgkin lymphoma (HL). Trials of BV with doxorubicin, vinblastine, and dacarbazine (AVD-BV) excluded patients with HIV. We studied the safety of (AVD-BV) in newly diagnosed HIV-associated classical Hodgkin lymphoma (HIV-cHL). DESIGN AND METHODS: Patients diagnosed with Stage II-IV HIV-cHL received AVD-BV on days 1 and 15 every 28 days for 6 cycles. Anti-HIV medications with strong CYP3A4 inhibition were excluded...
December 26, 2017: AIDS
https://www.readbyqxmd.com/read/29260599/alisertib-a-review-of-pharmacokinetics-efficacy-and-toxicity-in-patients-with-hematologic-malignancies-and-solid-tumors
#19
Susanne Liewer, Ashley Huddleston
Aurora kinases are essential mediators in cell mitosis. Amplification of these kinases can lead to the development of malignancy and may be associated with inferior survival. Alisertib is an oral aurora kinase inhibitor which has been shown to induce cell-cycle arrest and apoptosis in preclinical studies. It is currently under investigation for a wide variety of malignancies including hematologic (specifically Non-Hodgkin's lymphoma) and solid tumors. Areas covered: A PubMed search was performed to identify clinical studies reporting outcomes with alisertib...
December 20, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29248384/efficacy-and-tolerability-of-telmisartan-amlodipine-hydrochlorothiazide-versus-telmisartan-amlodipine-combination-therapy-for-essential-hypertension-uncontrolled-with-telmisartan-amlodipine-the-phase-iii-multicenter-randomized-double-blind-tahyti-study
#20
Ki-Chul Sung, Yong-Seog Oh, Dong-Hun Cha, Soon-Jun Hong, Kyung-Heon Won, Ki-Dong Yoo, Seung-Woon Rha, Young-Keun Ahn, Jeong-Cheon Ahn, Ji-Yong Jang, Tack-Jong Hong, Sang-Kyoon Cho, Sang-Ho Park, Min-Su Hyon, Chang-Wook Nam, In-Ho Chae, Byung-Su Yoo, Jong-Min Song, Jin-Ok Jeong, Young Won Yoon, Byung-Soo Kim, Tae-Hyun Yang, Deok-Kyu Cho, Sang-Hyun Kim, Yu-Jeong Choi, Ji-Hun Ahn, Dong-Woon Jeon, Hyo-Soo Kim
PURPOSE: This 8-week study in Korea aimed to evaluate the efficacy and tolerability of a telmisartan/amlodipine + hydrochlorothiazide (TAH) combination versus telmisartan/amlodipine (TA) combination in patients with essential hypertension that did not respond appropriately to 4-week treatment with TA. METHODS: All patients who met the inclusion criteria received TA (40/5 mg) during a 4-week run-in period (period 1). Patients who met the criteria for essential hypertension (mean sitting systolic blood pressure [MSSBP], ≥140 and <200 mm Hg, or ≥130 and<200 mm Hg in those with diabetes mellitus or chronic kidney disease) after period 1 were randomly assigned to receive TA 40/5 mg + hydrochlorothiazide 12...
December 13, 2017: Clinical Therapeutics
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