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Phase 3 hematology

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https://www.readbyqxmd.com/read/28810322/-comparison-of-generic-and-original-imatinib-in-the-treatment-of-newly-diagnosed-patients-with-chronic-myelogenous-leukemia-in-chronic-phase-a-multicenter-retrospective-clinical-study
#1
H Jiang, L T Zhi, M Hou, J X Wang, D P Wu, X J Huang
Objective: To evaluate the efficacy and safety of generic imatinib (Genike, Chiatai Tianqing Pharmaceutical Group Co., Ltd.) and imatinib (Glevic, Novartis, Switzerland) in newly diagnosed patients with chronic myeloid leukemia in chronic phase (CML-CP) . Methods: A retrospective study of 323 CML-CP patients (205 in Glivec treatment group and 118 in Genike group) who were ≥ 18 years old receiving imatinib monotherapy over the period of June 2013 to March 2016 was done to compare the differences of cytogenetics, molecular curative effect, survival, and adverse reactions between the two groups...
July 14, 2017: Zhonghua Xue Ye Xue za Zhi, Zhonghua Xueyexue Zazhi
https://www.readbyqxmd.com/read/28809608/treatment-of-patients-with-metastatic-cancer-using-a-major-histocompatibility-complex-class-ii-restricted-t-cell-receptor-targeting-the-cancer-germline-antigen-mage-a3
#2
Yong-Chen Lu, Linda L Parker, Tangying Lu, Zhili Zheng, Mary Ann Toomey, Donald E White, Xin Yao, Yong F Li, Paul F Robbins, Steven A Feldman, Pierre van der Bruggen, Christopher A Klebanoff, Stephanie L Goff, Richard M Sherry, Udai S Kammula, James C Yang, Steven A Rosenberg
Purpose Adoptive transfer of genetically modified T cells is being explored as a treatment for patients with metastatic cancer. Most current strategies use genes that encode major histocompatibility complex (MHC) class I-restricted T-cell receptors (TCRs) or chimeric antigen receptors to genetically modify CD8(+) T cells or bulk T cells for treatment. Here, we evaluated the safety and efficacy of an adoptive CD4(+) T-cell therapy using an MHC class II-restricted, HLA-DPB1*0401-restricted TCR that recognized the cancer germline antigen, MAGE-A3 (melanoma-associated antigen-A3)...
August 15, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28803233/comprehensive-analysis-of-the-chemical-composition-and-in-vitro-cytotoxic-mechanisms-of-pallines-spinosa-flower-and-leaf-essential-oils-against-breast-cancer-cells
#3
Ayman M Saleh, Mahmoud A Al-Qudah, Amre Nasr, Sayed A Rizvi, Anwar Borai, Mustafa Daghistani
BACKGROUND/AIMS: In our quest for new natural anticancer agents, we studied the cytotoxicity of the essential oils extracted from flowers and leaves of Pallines spinosa. METHODS: The essential oils were extracted by hydrodistillation and solid phase microextraction (SPME) from flowers and leaves of the plant and their composition was determined by GC/GC-MS. The cytotoxicity of the oils was evaluated against MCF-7 and MDA-MB-231 breast adenocarcinomas, and the non-cancerous MCF-10-2A cells, using a flow cytometry-based assay Apoptosis was evaluated by flow cytometry, nuclear staining, caspases activation, and Western blotting techniques, and cell cycle by measuring DNA contents...
August 11, 2017: Cellular Physiology and Biochemistry
https://www.readbyqxmd.com/read/28798910/changes-in-acylglycerols-composition-quality-characteristics-and-in-vivo-effects-of-dietary-pumpkin-seed-oil-upon-thermal-oxidation
#4
Alam Zeb, Sultan Ahmad
This study was aimed to determine the acylglycerols composition, quality characteristics, and protective role of dietary pumpkin seed oil (PSO) in rabbits. PSO was thermally oxidized and analyzed for quality characteristics and acylglycerols composition using reversed phase high performance liquid chromatography with diode array detection (HPLC-DAD). Oxidized and un-oxidized oil samples were fed to the rabbits in different doses for 2 weeks. The changes in the serum biochemistry, hematology, and liver histology were studied...
2017: Frontiers in Chemistry
https://www.readbyqxmd.com/read/28796812/toxicological-and-bio-distribution-profile-of-a-gm-csf-expressing-double-targeted-chimeric-oncolytic-adenovirus-oncos-102-support-for-clinical-studies-on-advanced-cancer-treatment
#5
Lukasz Kuryk, Lotta Vassilev, Tuuli Ranki, Akseli Hemminki, Aila Karioja-Kallio, Onerva Levälampi, Antti Vuolanto, Vincenzo Cerullo, Sari Pesonen
The purpose of this work was to carry out preclinical toxicity and bio-distribution studies required for regulatory approval of a clinical trial application for Phase I clinical studies of ONCOS-102 (Ad5/3-D24-GM-CSF) for therapy of advanced cancers (NCT01598129). The study design, route of administration and dosage differs from the clinical protocol and in more detail, investigate bio-distribution and toxicological profile of ONCOS-102 treatment in animal model. The study was carried out in 300 hamsters divided into nine test groups-three bio-distribution groups and six groups for analysis of toxicity...
2017: PloS One
https://www.readbyqxmd.com/read/28790114/differential-toxicity-in-patients-with-and-without-dna-repair-mutations-phase-i-study-of-carboplatin-and-talazoparib-in-advanced-solid-tumors
#6
Mallika S Dhawan, Imke H Bartelink, Rahul Aggarwal, Jim Leng, Jenna Z Zhang, Nela Pawlowska, Manuela Terranova-Barberio, Jennifer A Grabowsky, Andrew Gewitz, Amy J Chien, Mark M Moasser, Robin K Kelley, Tayeba Maktabi, Scott Thomas, Pamela N Munster
<p>Purpose: The PARP inhibitor, talazoparib, may potentiate activity of chemotherapy in cells vulnerable to DNA damage. EXPERIMENTAL DESIGN: This phase 1 study evaluated the safety, tolerability, pharmacokinetics (PK), and efficacy of talazoparib and carboplatin. Pharmacokinetic-modeling explored associations between dosing and hematological toxicity. RESULTS: 24 patients with solid tumors were enrolled in 4 cohorts at 0.75mg and 1mg daily talazoparib and weekly carboplatin (AUC 1 and 1...
August 8, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28771903/fludarabine-cytarabine-g-csf-and-idarubicin-for-children-with-relapsed-aml
#7
Hideki Nakayama, Daisuke Tomizawa, Shiro Tanaka, Shotaro Iwamoto, Akira Shimada, Akiko M Saito, Yuka Yamashita, Hiroshi Moritake, Kiminori Terui, Takashi Taga, Hidemasa Matsuo, Yoshiyuki Kosaka, Katsuyoshi Koh, Hajime Hosoi, Hidemitsu Kurosawa, Keiichi Isoyama, Keizo Horibe, Shuki Mizutani, Souichi Adachi
BACKGROUND: The combination of fludarabine (Flu), high dose cytarabine (Ara-C) and granulocyte-colony stimulating factor (G-CSF) called "FLAG" with anthracyclines has become a standard chemotherapy for refractory acute myeloid leukemia (AML) in European children and adults. To clarify the efficacy and the safety of FLAG-idarubicin (IDA) for children prospectively, we planned a multicenter phase II study (AML-R11) by Japanese Pediatric Leukemia/Lymphoma Study Group. METHODS: Patients with AML at the age between 2 and 20 years old, who had the first bone marrow (BM) relapse or induction failure, were enrolled...
August 3, 2017: Pediatrics International: Official Journal of the Japan Pediatric Society
https://www.readbyqxmd.com/read/28767428/suppression-of-mir-708-inhibits-the-wnt-%C3%AE-catenin-signaling-pathway-by-activating-dkk3-in-adult-b-all
#8
Yingjie Zhang, Huibo Li, Rongyi Cao, Lili Sun, Yan Wang, Shengjin Fan, Yanqiu Zhao, Desheng Kong, Lin Cui, Leilei Lin, Ke Wang, Yinghua Li, Jin Zhou
Inactivation of Dickkopf-3 (DKK3) is closely associated with a poor prognosis in various solid tumor and hematologic malignancies. Promoter hypermethylation is one potential cause of DKK3 inactivation. However, whether other mechanisms lead to DKK3 inactivation and the subsequent effects of these inactivations on cell proliferation and the Wnt signaling pathway in adult B acute lymphoblastic leukemia (B-ALL) remain unclear. In the present study, we found that low DKK3 expression levels were associated with high miR-708 expression and promoter hypermethylation in adult B-ALL...
July 18, 2017: Oncotarget
https://www.readbyqxmd.com/read/28765328/phase-1-dose-escalation-study-of-the-anti-cd70-antibody-argx-110-in-advanced-malignancies
#9
Philippe Aftimos, Christian Rolfo, Sylvie Rottey, Fritz Offner, Dominique D Bron, Marie Maerevoet, Jean-Charles Soria, Mahan Moshir, Torsten Dreier, Luc van Rompaey, Jean-Marie Michot, Karen Silence, Anna Hultberg, Domenica Gandini, Hans De Haard, Vincent Ribrag, Marc Peeters, Alain Thibault, Nicolas Leupin, Ahmad Awada
The purpose of this study was to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary antitumor efficacy of ARGX-110, a glyco-engineered monoclonal antibody, targeting CD70, in patients with CD70 expressing advanced malignancies. <br /><br />Experimental Design: <p>Dose escalation with a sequential 3+3 design was performed in five steps at the 0.1, 1, 2, 5, and 10 mg/kg dose levels (N=26). ARGX-110 was administered intravenously every three weeks until progression or intolerable toxicity...
August 1, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28761384/new-pd-l1-inhibitors-in-non-small-cell-lung-cancer-impact-of-atezolizumab
#10
REVIEW
Nagashree Seetharamu, Isabel R Preeshagul, Kevin M Sullivan
The era of immunotherapy has changed the face of how we approach treatment for many oncologic and hematologic malignancies. Lung cancer has been in the forefront of checkpoint inhibition for the past 2 years and has paved the path for other subspecialties. While PD-1 inhibitors nivolumab and pembrolizumab have been approved for non-small cell lung cancer (NSCLC), this review focuses on atezolizumab, its landmark studies, and ongoing trials. Atezolizumab is the first programmed death ligand 1 (PD-L1) inhibitor to receive US Food and Drug Administration (FDA) approval for metastatic NSCLC patients who have progressed on frontline chemotherapy...
2017: Lung Cancer: Targets and Therapy
https://www.readbyqxmd.com/read/28751440/exposure-response-of-veliparib-to-inform-phase%C3%A2-ii-trial-design-in-refractory-or-relapsed-patients-with-hematological-malignancies
#11
Shailly Mehrotra, Mathangi Gopalakrishnan, Jogarao Gobburu, Jiuping Jay Ji, Jacqueline M Greer, Richard L Piekarz, Judith Karp, Keith W Pratz, Michelle A Rudek
Purpose: A phase I trial of veliparib in combination with topotecan plus carboplatin (T+C) demonstrated 33% objective response rate in patients with hematological malignancies. The objective is to perform exposure-response analysis to inform the phase II trial design. <p>Experimental Design: Pharmacokinetic, efficacy and safety data from 95 patients, who were administered 10 to 100 mg BID doses of veliparib for either 8, 14 or 21 days with T+C, were utilized for exposure-efficacy (objective response and overall survival) and exposure-safety (≥Grade 3  mucositis) analysis...
July 27, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28744009/efficacy-and-safety-of-midostaurin-in-patients-with-advanced-systemic-mastocytosis-10-year-median-follow-up-of-a-phase-ii-trial
#12
D J DeAngelo, T I George, A Linder, C Langford, C Perkins, J Ma, P Westervelt, J D Merker, C Berube, S Coutre, M Liedtke, B Medeiros, D Sternberg, C Dutreix, P-A Ruffie, C Corless, T J Graubert, J Gotlib
Patients with advanced systemic mastocytosis (SM) (aggressive SM [ASM], SM with an associated hematologic neoplasm [SM-AHN], and mast cell leukemia [MCL]) have limited treatment options and exhibit reduced survival. Midostaurin is an oral multikinase inhibitor that inhibits D816V-mutated KIT, a primary driver of SM pathogenesis. We conducted a phase II trial of midostaurin 100 mg twice daily, administered as 28-day cycles, in 26 patients (ASM, n=3; SM-AHN, n=17; MCL, n=6) with at least one sign of organ damage...
July 24, 2017: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
https://www.readbyqxmd.com/read/28732386/a-phase-i-trial-of-nk-92-cells-for-refractory-hematological-malignancies-relapsing-after-autologous-hematopoietic-cell-transplantation-shows-safety-and-evidence-of-efficacy
#13
Brent A Williams, Arjun Datt Law, Bertrand Routy, Neal denHollander, Vikas Gupta, Xing-Hua Wang, Amélie Chaboureau, Sowmya Viswanathan, Armand Keating
BACKGROUND: Autologous NK cell therapy can treat a variety of malignancies, but is limited by patient-specific variations in potency and cell number expansion. In contrast, allogeneic NK cell lines can overcome many of these limitations. Cells from the permanent NK-92 line are constitutively activated, lack inhibitory receptors and appear to be safe based on two prior phase I trials. MATERIALS AND METHODS: We conducted a single-center, non-randomized, non-blinded, open-label, Phase I dose-escalation trial of irradiated NK-92 cells in adults with refractory hematological malignancies who relapsed after autologous hematopoietic cell transplantation (AHCT)...
July 12, 2017: Oncotarget
https://www.readbyqxmd.com/read/28726132/phase-i-dose-escalation-study-of-nms-1286937-an-orally-available-polo-like-kinase-1-inhibitor-in-patients-with-advanced-or-metastatic-solid-tumors
#14
Glen J Weiss, Gayle Jameson, Daniel D Von Hoff, Barbara Valsasina, Cristina Davite, Claudia Di Giulio, Francesco Fiorentini, Rachele Alzani, Patrizia Carpinelli, Alessandro Di Sanzo, Arturo Galvani, Antonella Isacchi, Ramesh K Ramanathan
Background Pharmacological inhibition of polo-like kinase 1 (PLK1) represents a new approach for the treatment of solid tumors. This study was aimed at determining the first cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose (MTD) of NMS-1286937, a selective ATP-competitive PLK1-specific inhibitor. Secondary objectives included evaluation of its safety and pharmacokinetic (PK) profile in plasma, its antitumor activity, and its ability to modulate intracellular targets in biopsied tissue...
July 20, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28726066/palliative-care-needs-in-hospitalized-cancer-patients-a-5-year-follow-up-study
#15
A Sandgren, P Strang
PURPOSE: The aims of this study were to describe and compare diagnoses, symptoms, and care needs in palliative cancer patients in two medium-sized hospitals in a county council with no specialized palliative care available 24/7; to analyze the relationships between diagnosis and symptoms/care needs; and to compare results and trends from two datasets (from 2007 and 2012). METHODS: The study was population-based with a cross-sectional design and was conducted at two acute care hospitals...
July 19, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28725989/imatinib-in-myeloid-lymphoid-neoplasms-with-eosinophilia-and-rearrangement-of-pdgfrb-in-chronic-or-blast-phase
#16
Mohamad Jawhar, Nicole Naumann, Juliana Schwaab, Herrad Baurmann, Jochen Casper, Tu-Anh Dang, Lutz Dietze, Konstanze Döhner, Annette Hänel, Bernd Lathan, Hartmut Link, Sina Lotfi, Ole Maywald, Stephan Mielke, Lothar Müller, Uwe Platzbecker, Otto Prümmer, Henrike Thomssen, Karin Töpelt, Jens Panse, Tom Vieler, Wolf-Karsten Hofmann, Torsten Haferlach, Claudia Haferlach, Alice Fabarius, Andreas Hochhaus, Nicholas C P Cross, Andreas Reiter, Georgia Metzgeroth
We evaluated clinical characteristics and outcome on imatinib of 22 patients with myeloid/lymphoid neoplasms with eosinophilia and rearrangement of PDGFRB. Median age was 49 years (range 20-80), 91% were male. Fifteen different PDGFRB fusion genes were identified. Eosinophilia was absent in 4/19 (21%) cases and only 11/19 (58%) cases had eosinophils ≥1.5×10(9)/L. On imatinib, 17/17 (100%) patients in chronic phase achieved complete hematologic remission after median 2 months (range 0-13)​. Complete cytogenetic remission and/or complete molecular remission by RT-PCR were achieved in 12/13 (92%) and 12/14 patients (86%) after median 10 (range 3-34) and 19 months (range 7-110), respectively...
September 2017: Annals of Hematology
https://www.readbyqxmd.com/read/28709705/phase-ii-trial-of-neoadjuvant-chemotherapy-followed-by-chemoradiation-in-locally-advanced-cervical-cancer
#17
Carla Rameri Alexandre Silva de Azevedo, Luiz Cláudio Santos Thuler, Maria Júlia Gonçalves de Mello, Jurema Telles de Oliveira Lima, Ana Luiza Fassizoli da Fonte, Diógenes Fernando Santos Fontão, Vandré Cabral Gomes Carneiro, Tien Man Cabral Chang, Carlos Gil Ferreira
OBJECTIVE: Cervical cancer is a global public health challenge. Since 1999, platin based chemoradiation (CRT) is the standard treatment for those patients with locally advanced disease. However, this population still has a dismal prognosis and, alternatives approaches such as adjuvant chemotherapy are controversial, especially because of increased toxicity. Neoadjuvant chemotherapy (NACT) could be an option for more intensive treatment with manageable toxicity. METHODS: A phase II, prospective, non-randomized trial was conducted at a reference center in Recife, Brazil...
July 11, 2017: Gynecologic Oncology
https://www.readbyqxmd.com/read/28708230/short-course-radiotherapy-concomitant-with-temozolomide-in-gbm-patients-a-phase-ii-study
#18
Laura Fariselli, Lucia Cuppini, Paola Gaviani, Marcello Marchetti, Valentina Pinzi, Ida Milanesi, Giorgia Simonetti, Irene Tramacere, Francesco DiMeco, Andrea Salmaggi, Antonio Silvani
PURPOSE: Despite recent advances, the prognosis of glioblastoma (GBM) remains poor. The aim of this study was to assess the efficacy and tolerability of multiple daily fraction radiotherapy performed with multiple temozolomide (TMZ) administrations in newly diagnosed patients with GBM. METHODS: This trial was a prospective, open-label, monocentric, nonrandomized, single arm, phase II study. The primary endpoint was the proportion of progression-free patients at 12 months, and the secondary endpoints were overall survival (OS) and toxicity...
July 8, 2017: Tumori
https://www.readbyqxmd.com/read/28705540/three-year-safety-of-radium-223-dichloride-in-patients-with-castration-resistant-prostate-cancer-and-symptomatic-bone-metastases-from-phase-3-randomized-alpharadin-in-symptomatic-prostate-cancer-trial
#19
Christopher C Parker, Robert E Coleman, Oliver Sartor, Nicholas J Vogelzang, David Bottomley, Daniel Heinrich, Svein I Helle, Joe M O'Sullivan, Sophie D Fosså, Aleš Chodacki, Paweł Wiechno, John Logue, Mihalj Seke, Anders Widmark, Dag Clement Johannessen, Peter Hoskin, Nicholas D James, Arne Solberg, Isabel Syndikus, Jan Kliment, Steffen Wedel, Sibylle Boehmer, Marcos Dall'Oglio, Lars Franzén, Øyvind S Bruland, Oana Petrenciuc, Karin Staudacher, Rui Li, Sten Nilsson
BACKGROUND: In Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial, radium-223 versus placebo prolonged overall survival with favorable safety in castration-resistant prostate cancer patients with symptomatic bone metastases. Long-term radium-223 monitoring underlies a comprehensive safety and risk/benefit assessment. OBJECTIVE: To report updated ALSYMPCA safety, including long-term safety up to 3 yr after the first injection. DESIGN, SETTING, AND PARTICIPANTS: Safety analyses from phase 3 randomized ALSYMPCA trial included patients receiving ≥1 study-drug injection (600 radium-223 and 301 placebo)...
July 10, 2017: European Urology
https://www.readbyqxmd.com/read/28704757/structural-optimization-elaborates-novel-potent-akt-inhibitors-with-promising-anticancer-activity
#20
Yang Liu, Yanzhen Yin, Zhen Zhang, Carrie J Li, Hui Zhang, Daoguang Zhang, Changying Jiang, Krystle Nomie, Liang Zhang, Michael L Wang, Guisen Zhao
Targeting of Akt has been validated as a well rationalized approach to cancer treatment, and represents a promising therapeutic strategy for aggressive hematologic malignancies. We describe herein an exploration of novel Akt inhibitors for cancer therapy through structural optimization of previously described 4-(piperazin-1-yl)-7H-pyrrolo[2,3-d]pyrimidine derivatives. Our studies yielded a novel series of pyrrolopyrimidine based phenylpiperidine carboxamides capable of potent inhibition of Akt1. Notably, 10h exhibited robust antiproliferative effects in both mantle cell lymphoma cell lines and primary patient tumor cells...
June 30, 2017: European Journal of Medicinal Chemistry
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