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Phase 3 hematology

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https://www.readbyqxmd.com/read/28095146/phase-i-first-in-human-study-of-venetoclax-in-patients-with-relapsed-or-refractory-non-hodgkin-lymphoma
#1
Matthew S Davids, Andrew W Roberts, John F Seymour, John M Pagel, Brad S Kahl, William G Wierda, Soham Puvvada, Thomas J Kipps, Mary Ann Anderson, Ahmed Hamed Salem, Martin Dunbar, Ming Zhu, Franklin Peale, Jeremy A Ross, Lori Gressick, Monali Desai, Su Young Kim, Maria Verdugo, Rod A Humerickhouse, Gary B Gordon, John F Gerecitano
Purpose B-cell leukemia/lymphoma-2 (BCL-2) overexpression is common in many non-Hodgkin lymphoma (NHL) subtypes. A phase I trial in patients with NHL was conducted to determine safety, pharmacokinetics, and efficacy of venetoclax, a selective, potent, orally bioavailable BCL-2 inhibitor. Patients and Methods A total of 106 patients with relapsed or refractory NHL received venetoclax once daily until progressive disease or unacceptable toxicity at target doses from 200 to 1,200 mg in dose-escalation and safety expansion cohorts...
January 17, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28076329/feasibility-of-abbreviated-cycles-of-immunochemotherapy-for-completely-resected-limited-stage-cd20-diffuse-large-b-cell-lymphoma-cisl-12-09
#2
Dok Hyun Yoon, Byeong Seok Sohn, Sung Yong Oh, Won-Sik Lee, Sang Min Lee, Deok-Hwan Yang, Jooryung Huh, Cheolwon Suh
BACKGROUND: The appropriate number of chemotherapy cycles for limited stage diffuse large B-cell lymphoma (DLBCL) patients without gross residual lesions after complete resection, has not been specifically questioned. We performed a multicenter, single-arm, phase 2 study to investigate the feasibility of 3 cycles of abbreviated R-CHOP chemotherapy in low-risk patients with completely resected localized CD20+ DLBCL. RESULTS: Between December 2010 and May 2013, we recruited 23 patients...
January 5, 2017: Oncotarget
https://www.readbyqxmd.com/read/28072457/effects-of-binge-like-ethanol-exposure-during-adolescence-on-the-febrile-response-in-rats
#3
Tatiane M B B Telles, Bruna M T de Oliveira, Luiz A Lomba, Mariane G Leite-Avalca, Diego Correia, Aleksander R Zampronio
BACKGROUND: Ethanol exposure during different phases of life may increase the risk of infections and cause alterations in the central nervous system. The present study investigated the effects of binge-like ethanol exposure in adolescent rats on the febrile response that was induced by lipopolysaccharide (LPS) and interleukin-1β (IL-1β). METHODS: Male rats were exposed to ethanol from postnatal day 25 to 38 in a binge-like pattern. Fever was induced by LPS (5 and 50 μg/kg, intraperitoneally) and evaluated on postnatal day 51 and 63, or by IL-β (3 ng) and evaluated on postnatal day 51...
January 10, 2017: Alcoholism, Clinical and Experimental Research
https://www.readbyqxmd.com/read/28069354/bufadienolides-from-amphibians-a-promising-source-of-anticancer-prototypes-for-radical-innovation-apoptosis-triggering-and-na-k-atpase-inhibition
#4
REVIEW
Lívia Queiroz de Sousa, Kátia da Conceição Machado, Samara Ferreira de Carvalho Oliveira, Lidiane da Silva Araújo, Evaldo Dos Santos Monção-Filho, Ana Amélia de Carvalho Melo-Cavalcante, Gerardo Magela Vieira-Júnior, Paulo Michel Pinheiro Ferreira
Amphibians present pharmacologically active aliphatic, aromatic and heterocyclic molecules in their skin as defense against microorganisms, predators and infections, such as steroids, alkaloids, biogenic amines, guanidine derivatives, proteins and peptides. Based on the discovered bioactive potential of bufadienolides, this work reviewed the contribution of amphibians, especially from members of Bufonidae family, as source of new cytotoxic and antitumor molecules, highlighting the mechanisms responsible for such amazing biological potentialities...
January 6, 2017: Toxicon: Official Journal of the International Society on Toxinology
https://www.readbyqxmd.com/read/28060563/efficacy-and-safety-of-elotuzumab-for-the-treatment-of-multiple-myeloma
#5
Maria Gavriatopoulou, Evangelos Terpos, Efstathios Kastritis, Meletios A Dimopoulos
Multiple myeloma (MM) is the second most common hematologic malignancy and despite significant outcome improvements with novel agents, the majority of patients will eventually relapse and develop treatment resistance. Immunotherapy is emerging as a promising therapeutic approach in MM. Areas covered: Elotuzumab is a monoclonal antibody directly targeting the SLAMF7 receptor, expressed on normal and malignant plasma cells. Elotuzumab has no meaningful antimyeloma activity when given as monotherapy to patients with relapsed or refractory MM (RRMM)...
January 6, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28059968/multicenter-phase-ii-study-of-intravenous-and-intraperitoneal-paclitaxel-with-s-1-for-pancreatic-ductal-adenocarcinoma-patients-with-peritoneal-metastasis
#6
Sohei Satoi, Tsutomu Fujii, Hiroaki Yanagimoto, Fuyuhiko Motoi, Masanao Kurata, Naminatsu Takahara, Suguru Yamada, Tomohisa Yamamoto, Masamichi Mizuma, Goro Honda, Hiroyuki Isayama, Michiaki Unno, Yasuhiro Kodera, Hironori Ishigami, Masanori Kon
OBJECTIVE: To evaluate the clinical efficacy and tolerability of intravenous (i.v.) and intraperitoneal (i.p.) paclitaxel combined with S-1, "an oral fluoropyrimidine derivative containing tegafur, gimestat, and otastat potassium" in chemotherapy-naive pancreatic ductal adenocarcinoma (PDAC) patients with peritoneal metastasis. BACKGROUND: PDAC patients with peritoneal metastasis (peritoneal deposits and/or positive peritoneal cytology) have an extremely poor prognosis...
February 2017: Annals of Surgery
https://www.readbyqxmd.com/read/28058445/safety-and-pharmacokinetics-of-cabazitaxel-in-patients-with-hepatic-impairment-a-phase-i-dose-escalation-study
#7
John Sarantopoulos, Alain C Mita, Aiwu He, James L Wade, Chung-Tsen Hsueh, John C Morris, A Craig Lockhart, David I Quinn, Jimmy Hwang, James Mier, Wenping Zhang, Claudine Wack, Jian Yin, Pierre-François Clot, Olivier Rixe
PURPOSE: Cabazitaxel has not been studied in patients with hepatic impairment (HI). This phase I study assessed cabazitaxel safety and pharmacokinetics in patients with HI. METHODS: Patients with advanced, non-hematologic cancer, and normal hepatic function (Cohort 1: C-1), or mild (C-2), moderate (C-3), severe (C-4) HI received cabazitaxel starting doses of 25, 20, 10, and 10 mg/m(2), respectively. Doses were escalated in patients with HI based on Cycle 1 dose-limiting toxicities (DLTs)...
January 5, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28034993/lenalidomide-combined-with-intensive-chemotherapy-in-acute-myeloid-leukemia-and-higher-risk-myelodysplastic-syndrome-with-5q-deletion-results-of-a-phase-ii-study-by-the-groupe-francophone-des-myelodysplasies
#8
Lionel Ades, Thomas Prebet, Aspasia Stamatoullas, Christian Recher, Romain Guieze, Emmanuel Raffoux, Krimo Bouabdallah, Mathilde Hunault, Eric Wattel, Laure Stalnikiewicz, Andrea Toma, Herve' Dombret, Nobert Vey, Marie Sebert, Claude Gardin, Cendrine Chaffaut, Sylvie Chevret, Pierre Fenaux
Patients with acute myeloblastic leukemia or higher risk myelodysplastic syndromes with 5q deletion (generally within complex karyotype) respond poorly to intensive chemotherapy and have very poor survival. In this population, we evaluated escalating doses of lenalidomide combined with IC in a phase II study (NCT00885508) Treatment consisted of daunorubicin (45 mg/m2/d1-3 in cohort 1, escalated to 60mg/m2/1-3 in cohorts2 and 3) combined with AraC (200mg/m2/ d1-7) and lenalidomide (10mg/d1-21 in cohorts1 and 2, escalated to 25mg/d1-21 in cohort 3)...
December 29, 2016: Haematologica
https://www.readbyqxmd.com/read/28028026/diagnosis-risk-stratification-and-response-evaluation-in-classical-myeloproliferative-neoplasms
#9
Elisa Rumi, Mario Cazzola
Philadelphia-negative classical myeloproliferative neoplasms include polycythemia vera, essential thrombocythemia, and primary myelofibrosis. The 2016 revision of the World Health Organization (WHO) classification of tumors of hematopoietic and lymphoid tissues includes new criteria for the diagnosis of these disorders. Somatic mutations in the 3 driver genes, that is, JAK2, CALR, and MPL, represent major diagnostic criteria in combination with hematologic and morphological abnormalities. Polycythemia vera is characterized by erythrocytosis with suppressed endogenous erythropoietin production, bone marrow panmyelosis, and JAK2 mutation...
December 27, 2016: Blood
https://www.readbyqxmd.com/read/28025945/double-blind-placebo-controlled-randomized-phase-i-iia-study-safety-and-efficacy-with-buspirone-levodopa-carbidopa-spinalontm-in-subjects-with-complete-ais-a-or-motor-complete-ais-b-spinal-cord-injury
#10
Mohan Radhakrishna, Inge Steuer, François Prince, Mary Roberts, David Mongeon, Maryam Kia, Sasha Dyck R N, Gilbert Matte, Mario Vaillancourt, Pierre A Guertin
BACKGROUND: No drug treatment capable of restoring locomotor capabilities in patients suffering a motor-complete spinal cord injury (SCI) has ever been developed. We assessed the safety and efficacy of an activator of spinal locomotor neurons in humans, which were shown in paraplegic animals to elicit temporary episodes of involuntary walking. METHODS: Single administration of buspirone/levodopa/carbidopa (Spinalon TM), levodopa/carbidopa (ratio 4: 1), and buspirone or placebo was performed using a dose-escalation design in 45 subjects placed in supine position who had had an SCI classified as complete (AIS A) or motor-complete/sensory incomplete (AIS B) for at least 3 months...
December 27, 2016: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28024491/-children-s-nk-t-cell-lymphoma-associated-hemophagocytic-syndrome-clinical-analysis-of-6-cases
#11
Yong-Zhi Zheng, Hao Zheng, Jian Li, Shao-Hua LE, Xue-Ling Hua, Zai-Sheng Chen, Ling Zheng, Mei Li, Yi-Qiao Chen, Qin-Li Gao, Jing-Hui Yang, Jian-Da Hu
OBJECTIVE: To study the clinical features, treatment and prognosis of patients with NK/T cell lymphoma-associated hemophagocytic syndrome(NK/T-LAHPS). METHODS: Retrospective analysis was used to explore the clinical data of 6 children with NK/T-LAHPS who were admitted in Department of Pediatric Hematology of Fujian Medical University Union Hospital from July 2012 to June 2016. The 6 patients included 4 boys and 2 girls, with a median age of 4 years(range 1.75 to 11)...
December 2016: Zhongguo Shi Yan Xue Ye Xue za Zhi
https://www.readbyqxmd.com/read/28011903/safety-and-efficacy-of-obinutuzumab-with-chop-or-bendamustine-in-previously-untreated-follicular-lymphoma
#12
Andrew Grigg, Martin J S Dyer, Marcos González Díaz, Martin Dreyling, Simon Rule, Guiyuan Lei, Andrea Knapp, Elisabeth Wassner-Fritsch, Paula Marlton
The GAUDI study assessed safety and preliminary efficacy of induction therapy with obinutuzumab plus chemotherapy, followed by maintenance with obinutuzumab alone, in previously untreated patients with follicular lymphoma. Assignment to chemotherapy was decided on a per center basis before patient enrollment. Patients (n=81) received 4-6 cycles of obinutuzumab plus bendamustine every 4 weeks or 6-8 cycles of obinutuzumab plus CHOP every 3 weeks. Patients with an end-of-treatment response were eligible for obinutuzumab maintenance therapy every 3 months for 2 years or until disease progression...
December 23, 2016: Haematologica
https://www.readbyqxmd.com/read/27978552/comparison-of-concurrent-use-of-thoracic-radiation-with-either-carboplatin-paclitaxel-or-cisplatin-etoposide-for-patients-with-stage-iii-non-small-cell-lung-cancer-a-systematic-review
#13
Conor E Steuer, Madhusmita Behera, Vinicius Ernani, Kristin A Higgins, Nabil F Saba, Dong M Shin, Suchita Pakkala, Rathi N Pillai, Taofeek K Owonikoko, Walter J Curran, Chandra P Belani, Fadlo R Khuri, Suresh S Ramalingam
Importance: The 2 most common chemotherapy regimens used concurrently with thoracic radiation for patients with unresectable IIIA and IIIB non-small-cell lung cancer (NSCLC) are carboplatin-paclitaxel and cisplatin-etoposide. There are no prospective comparisons of these 2 regimens in this setting. Objective: To conduct a systematic review of published trials to compare outcomes and toxic effects between cisplatin-etoposide and carboplatin-paclitaxel in patients with non-small-cell lung cancer receiving thoracic radiation...
December 15, 2016: JAMA Oncology
https://www.readbyqxmd.com/read/27967301/analysis-of-hematologic-alterations-immune-responses-and-metallothionein-gene-expression-in-nile-tilapia-oreochromis-niloticus-exposed-to-silver-nanoparticles
#14
Kubpaphas Thummabancha, Nuttaphon Onparn, Prapansak Srisapoome
In this study, Nile tilapia (Oreochromis niloticus) fingerlings were used as a model to examine acute and chronic toxicity of silver nanoparticles (AgNP). Expression levels of metallothionein (MT) transcripts in fish exposed to 0, 1 or 100 mg AgNP/kg fish were investigated by quantitative real-time RT-PCR. The results showed MT expression levels were significantly decreased 0.3-0.7-fold in the liver and spleen of fish exposed to 1 or 100 mg AgNP/kg after 6-48 h. In contrast, during this period, MT mRNA expression levels were increased 2-3-fold in the head kidney of the fish exposed to either level of AgNP...
November 2016: Journal of Immunotoxicology
https://www.readbyqxmd.com/read/27938485/neuroprotection-of-granulocyte-colony-stimulating-factor-for-early-stage-parkinson%C3%A2-s-disease
#15
Sheng-Tzung Tsai, Sung-Chao Chu, Shu-Hsin Liu, Cheng-Yoong Pang, TingWen Hou, Shinn-Zong Lin, Shin-Yuan Chen
Parkinson’s disease (PD) is a slowly progressive neurodegenerative disease. Both medical and surgical choicesprovide symptomatic treatment. Granulocyte colonystimulating factor (G-CSF), a conventional treatment for hematological diseases, has demonstrated its effectiveness in acute and chronic neurological diseases through its anti-inflammatory and anti-apoptosis mechanisms. Based on previous <em>in vitro</em> and <em>in vivo</em> studies, we administered a lower-dose (3.3 µg/kg) G-CSF injection for five days and six courses during one year in early stage PD patients as a phase I trial...
7, 2016: Cell Transplantation
https://www.readbyqxmd.com/read/27931828/targeting-mtor-pathway-in-gynecological-malignancies-biological-rationale-and-systematic-review-of-published-data
#16
REVIEW
Loay Kassem, Omar Abdel-Rahman
BACKGROUND: mTOR inhibitors are widely used in different malignancies with several trials testing their efficacy and safety in gynecological malignancies. We aimed to review the current evidence that support the expansion of using such drugs in the treatment of advanced gynecological cancers. METHODS: A comprehensive systematic review of literature has been conducted to include prospective trials that used everolimus, temsirolimus or ridaforolimus in the management of gynecological cancers and have available efficacy and toxicity results...
December 2016: Critical Reviews in Oncology/hematology
https://www.readbyqxmd.com/read/27931230/feasibility-and-efficacy-of-gemcitabine-and-docetaxel-combination-chemotherapy-for-bone-and-soft-tissue-sarcomas-multi-institutional-retrospective-analysis-of-134-patients
#17
Kazuhiro Tanaka, Susumu Joyama, Hirokazu Chuman, Hiroaki Hiraga, Hideo Morioka, Hideki Yoshikawa, Masami Hosaka, Mitsuru Takahashi, Tadahiko Kubo, Hiroshi Hatano, Mitsunori Kaya, Junya Toguchida, Yoshihiro Nishida, Akihito Nagano, Hiroshi Tsumura, Yukihide Iwamoto
BACKGROUND: Bone and soft tissue sarcomas (BSTS) are rare malignant tumors. Recently, the combination of gemcitabine and docetaxel (GD) was shown to have activity as second-line setting in BSTS. However, the efficacy as first-line and adjuvant settings and precise profiles of adverse events in Japanese patients are not known yet. In the present study, the feasibility and efficacy of GD in patients with BSTS were investigated. METHODS: Patients with BSTS treated with GD in our institutions were retrospectively analyzed...
December 8, 2016: World Journal of Surgical Oncology
https://www.readbyqxmd.com/read/27927766/phase-1-dose-finding-study-of-rebastinib-dcc-2036-in-patients-with-relapsed-chronic-myeloid-leukemia-and-acute-myeloid-leukemia
#18
Jorge Cortes, Moshe Talpaz, Hedy P Smith, David S Snyder, Jean Khoury, Kapil N Bhalla, Javier Pinilla-Ibarz, Richard Larson, David Mitchell, Scott C Wise, Thomas J Rutkoski, Bryan D Smith, Daniel L Flynn, Hagop M Kantarjian, Oliver Rosen, Richard A Van Etten
Available tyrosine kinase inhibitors for chronic myeloid leukemia bind in an ATP-binding pocket and are affected by evolving mutations that confer resistance. Rebastinib was identified as a switch control inhibitor of BCR-ABL1 and FLT3 and may be active against resistant mutations. A Phase 1, first in human, single-agent study investigated rebastinib in relapsed or refractory chronic or acute myeloid leukemia. Primary objectives were to investigate the safety of rebastinib and establish the maximum tolerated dose (MTD) and recommended Phase 2 dose...
December 7, 2016: Haematologica
https://www.readbyqxmd.com/read/27916045/-a-comparison-of-efficacy-and-safety-between-chinese-generic-imatinib-versus-branded-imatinib-in-patients-with-newly-diagnosed-chronic-myeloid-leukemia-in-the-chronic-phase-a-single-center-prospective-cohort-study
#19
H X Shi, Y Z Qin, Y Y Lai, X J Huang, Q Jiang
Objective: To compare the efficacy and safety between Chinese generic imatinib (Xinwei(®), Jiansu Hansoh Pharmaceutical Group Co., Ltd.) versus branded imatinib (Glivec(®), Novartis) in patients with newly-diagnosed chronic myeloid leukemia in chronic phase (CML-CP). Methods: Patients with newly diagnosed CML-CP were enrolled and assigned to receive either Xinwei or Glivec at an initial dose of 400 mg/d according to patients' financial capability. The efficacy and adverse effects were evaluated. Results: From January 2014 to September 2015, 145 eligible patients were assigned to Xinwei (n=89) or Glivec (n=56) group...
December 1, 2016: Zhonghua Nei Ke za Zhi [Chinese Journal of Internal Medicine]
https://www.readbyqxmd.com/read/27911128/s-1-in-combination-with-docetaxel-and-oxaliplatin-in-patients-with-advanced-gastro-esophageal-adenocarcinoma-two-parallel-phase-1-2a-studies
#20
Per Pfeiffer, Camilla Qvortrup, Merete Krogh, Katrine Schoennemann, Lene W Vestermark, Helle A Jensen, Jon K Bjerregaard
BACKGROUND: Docetaxel in combination with cisplatin and 5-fluorouracil (5-FU) is one of several standard chemotherapy regimens for patients with advanced gastro-esophageal adenocarcinoma (aGEA) in Europe. To enable outpatient treatment, we evaluated the maximum tolerated dose (MTD), recommended dose (RD), dose limiting toxicity (DLT) and safety of docetaxel in combination with oxaliplatin (O) and S-1 (DOS) in Caucasian patients with aGEA. METHODS: We present final results of two parallel phase 1/2a studies (3 + 3 design)...
January 2017: Acta Oncologica
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