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Phase 3 hematology

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https://www.readbyqxmd.com/read/28444644/ponatinib-in-japanese-patients-with-philadelphia-chromosome-positive-leukemia-a-phase-1-2-study
#1
Arinobu Tojo, Taiichi Kyo, Kazuhito Yamamoto, Hirohisa Nakamae, Naoto Takahashi, Yukio Kobayashi, Tetsuzo Tauchi, Shinichiro Okamoto, Koichi Miyamura, Kiyohiko Hatake, Hiromi Iwasaki, Itaru Matsumura, Noriko Usui, Tomoki Naoe, Meera Tugnait, Narayana I Narasimhan, Stephanie Lustgarten, Heinrich Farin, Frank Haluska, Kazuma Ohyashiki
In this ongoing Phase 1/2 study (NCT01667133), we evaluated ponatinib and assessed its recommended dose in Japanese patients with chronic myeloid leukemia (CML) resistant/intolerant to dasatinib or nilotinib, or with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph(+)ALL) resistant/intolerant to ≥1 tyrosine kinase inhibitor (TKI). The primary endpoints were safety of the recommended dose (Phase 1) and major cytogenetic response (MCyR) by 12 months in chronic-phase CML (CP-CML) patients or major hematologic response (MaHR) by 6 months in patients with advanced phase disease (Phase 2)...
April 25, 2017: International Journal of Hematology
https://www.readbyqxmd.com/read/28436593/results-for-patients-with-sarcoma-not-otherwise-specified-and-other-diagnoses-than-ewing-sarcoma-treated-according-to-the-euro-ewing-99-trial
#2
Judith Amalie Frank, Andreas Ranft, Michael Paulussen, Heribert Juergens, Jarmila Kruseova, Sebastian Bauer, Felix Niggli, Peter Reichardt, Uta Dirksen
BACKGROUND: Euro-EWING 99 trial of the European Ewing tumor Working Initiative of National Groups (EE99) was an international phase III study in patients with Ewing sarcoma. The German Society of Pediatric Oncology and Hematology (GPOH) data center registered and followed patients with other diagnoses than Ewing sarcoma who were treated according to the EE99 protocol in an additional non-Ewing database. PROCEDURE: Data of 27 patients with other diagnoses than Ewing sarcoma treated according to the EE99 protocol were analyzed...
April 24, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28432176/a-phase-i-study-of-the-cdk4-6-inhibitor-ribociclib-lee011-in-pediatric-patients-with-malignant-rhabdoid-tumors-neuroblastoma-and-other-solid-tumors
#3
Birgit Geoerger, Franck Bourdeaut, Steven G DuBois, Matthias Fischer, James I Geller, Nicholas G Gottardo, Aurélien Marabelle, Andrew D J Pearson, Shakeel Modak, Thomas Cash, Giles W Robinson, Marlyane Motta, Alessandro Matano, Suraj G Bhansali, Jason R Dobson, Sudha Parasuraman, Susan N Chi
Purpose: The cyclin-dependent kinase (CDK) 4/6 inhibitor, ribociclib (LEE011), displayed preclinical activity in neuroblastoma and malignant rhabdoid tumor (MRT) models. In this phase I study, the maximum tolerated dose (MTD) and recommended phase II dose (RP2D), safety, pharmacokinetics (PK), and preliminary activity of single-agent ribociclib were investigated in pediatric patients with neuroblastoma, MRT, or other cyclin D-CDK4/6-INK4-retinoblastoma pathway-altered tumors.Experimental Design: Patients (aged 1-21 years) received escalating once-daily oral doses of ribociclib (3-weeks-on/1-week-off)...
April 21, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28426538/five-phases-of-recovery-and-rehabilitation-after-allogeneic-stem-cell-transplantation-a-qualitative-study
#4
Mariska C M van der Lans, Frederika E Witkamp, Wendy H Oldenmenger, Annoek E C Broers
BACKGROUND: For patients with a hematological malignancy, allogeneic stem cell transplantation (alloSCT) is a treatment modality that may cause a wide range of problems. Little is known about the process of recovery and rehabilitation and the problems that alloSCT patients are confronted with during the first-year posttransplant. OBJECTIVE: This study explored the problems of patients during the first year after alloSCT, to better understand the process of recovery and rehabilitation...
April 20, 2017: Cancer Nursing
https://www.readbyqxmd.com/read/28423296/eltrombopag-added-to-standard-immunosuppression-for-aplastic-anemia
#5
Danielle M Townsley, Phillip Scheinberg, Thomas Winkler, Ronan Desmond, Bogdan Dumitriu, Olga Rios, Barbara Weinstein, Janet Valdez, Jennifer Lotter, Xingmin Feng, Marie Desierto, Harshraj Leuva, Margaret Bevans, Colin Wu, Andre Larochelle, Katherine R Calvo, Cynthia E Dunbar, Neal S Young
Background Acquired aplastic anemia results from immune-mediated destruction of bone marrow. Immunosuppressive therapies are effective, but reduced numbers of residual stem cells may limit their efficacy. In patients with aplastic anemia that was refractory to immunosuppression, eltrombopag, a synthetic thrombopoietin-receptor agonist, led to clinically significant increases in blood counts in almost half the patients. We combined standard immunosuppressive therapy with eltrombopag in previously untreated patients with severe aplastic anemia...
April 20, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28413662/phase-i-study-of-nanoparticle-albumin-bound-paclitaxel-carboplatin-and-trastuzumab-in-women-with-human-epidermal-growth-factor-receptor-2-overexpressing-breast-cancer
#6
Kenji Tezuka, Tsutomu Takashima, Shinichiro Kashiwagi, Hidemi Kawajiri, Shinya Tokunaga, Seika Tei, Shigehiko Nishimura, Shigehito Yamagata, Satoru Noda, Takeo Nishimori, Yoko Mizuyama, Takeshi Sunami, Katsumi Ikeda, Yoshinari Ogawa, Naoyoshi Onoda, Tetsuro Ishikawa, Shinzoh Kudoh, Minoru Takada, Kosei Hirakawa
Although the concurrent use of anthracycline-containing chemotherapy and taxane with trastuzumab are considered the treatment of choice for the primary systemic therapy of human epidermal growth factor receptor 2 (HER2)-overexpressing early breast cancer, non-anthracycline regimens, such as concurrent administration of docetaxel and carboplatin with trastuzumab, exhibited similar efficacies in a previous study. In addition, tri-weekly treatment with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) resulted in significantly higher response rates and a favorable safety profile compared with standard paclitaxel for metastatic breast cancer patients in another phase III study...
April 2017: Molecular and Clinical Oncology
https://www.readbyqxmd.com/read/28409853/a-phase-1-study-of-the-cxcr4-antagonist-plerixafor-in-combination-with-high-dose-cytarabine-and-etoposide-in-children-with-relapsed-or-refractory-acute-leukemias-or-myelodysplastic-syndrome-a-pediatric-oncology-experimental-therapeutics-investigators-consortium
#7
Todd M Cooper, Edward Allan Racela Sison, Sharyn D Baker, Lie Li, Amina Ahmed, Tanya Trippett, Lia Gore, Margaret E Macy, Aru Narendran, Keith August, Michael J Absalon, Jessica Boklan, Jessica Pollard, Daniel Magoon, Patrick A Brown
BACKGROUND: Plerixafor, a reversible CXCR4 antagonist, inhibits interactions between leukemic blasts and the bone marrow stromal microenvironment and may enhance chemosensitivity. A phase 1 trial of plerixafor in combination with intensive chemotherapy in children and young adults with relapsed or refractory acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), and myelodysplastic syndrome (MDS) was performed to determine a tolerable and biologically active dose. PROCEDURE: Plerixafor was administered daily for 5 days at four dose levels (6, 9, 12, and 15 mg/m(2) /dose) followed 4 hr later by high-dose cytarabine (every 12 hr) and etoposide (daily)...
April 14, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28409328/long-term-treatment-with-bosutinib-in-a-phase-1-2-study-in-japanese-chronic-myeloid-leukemia-patients-resistant-intolerant-to-prior-tyrosine-kinase-inhibitor-treatment
#8
Naoto Takahashi, Chiaki Nakaseko, Yukio Kobayashi, Koichi Miyamura, Chiho Ono, Yuichiro Koide, Yosuke Fujii, Kazunori Ohnishi
This long-term follow-up of a completed phase 1/2 study assessed the safety and efficacy of bosutinib in Japanese Philadelphia chromosome-positive, chronic phase (CP) or advanced phase (ADV) chronic myeloid leukemia patients who were resistant/refractory or intolerant to prior tyrosine kinase inhibitor treatment. This analysis included 63 patients with a median bosutinib follow-up of 132 weeks (range 3‒372). In the CP second-line (2L) cohort, the cumulative major cytogenetic response (MCyR) and major molecular response (MMR) rates throughout the study were 73 and 53%, respectively...
April 13, 2017: International Journal of Hematology
https://www.readbyqxmd.com/read/28403082/metronomic-oral-cyclosphosphamide-as-third-line-systemic-treatment-or-beyond-in-patients-with-inoperable-locoregionally-advanced-recurrent-or-metastatic-nasopharyngeal-carcinoma
#9
Victor H F Lee, Dora L W Kwong, Ka-On Lam, Yu-Ching Lai, Yun Li, Chi-Chung Tong, Patty P Y Ho, Wing-Lok Chan, Lai-San Wong, Dennis K C Leung, Sum-Yin Chan, Fong-Ting Chan, To-Wai Leung, Anne W M Lee
There is no standard third-line or further systemic treatment for patients with inoperable locoregionally advanced recurrent or metastatic nasopharyngeal carcinoma (NPC). Metronomic oral cyclophosphamide provides an acceptable and cheap option for these heavily pretreated patients who had limited choices. We conducted a prospective phase II single-arm open-label study of metronomic oral cyclophosphamide. Patients with locoregionally advanced recurrent inoperable (rT3/T4, rN2-N3b) or metastatic (rM1) NPC who had Eastern Cooperative Oncology Group (ECOG) performance status (PS) (0-2) and had progressed after at least 2 lines of palliative systemic chemotherapy were eligible...
April 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28396162/phase-i-study-of-clofarabine-and-2-gy-total-body-irradiation-as-a-non-myeloablative-preparative-regimen-for-hematopoietic-stem-cell-transplantation-hsct-in-pediatric-patients-with-hematologic-malignancies-a-therapeutic-advances-in-childhood-leukemia-tacl-consortium
#10
Sandeep Soni, Hisham Abdel-Azim, Meghann McManus, Eneida Nemecek, Richard Sposto, Ann Woolfrey, Haydar Frangoul
Clofarabine is a purine nucleoside analog with immunosuppressive and anti-leukemic activity and its inclusion in reduced intensity regimens could potentially improve outcomes. We performed a prospective Phase I study of clofarabine combined with 2 Gy total body irradiation (TBI) as a non-myeloablative (NMA) preparative regimen for allogeneic stem cell transplantation in pediatric patients, who were considered at high risk of mortality from standard myeloablative regimens. The main goal of the study was to delineate the maximum feasible dose (MFD) of clofarabine in combination with 2 Gy TBI...
April 7, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28385537/phase-i-trial-of-everolimus-and-capecitabine-in-metastatic-her2-breast-cancer
#11
Gregory A Vidal, Mary Chen, Shruti Sheth, Tiffany Svahn, Ellie Guardino
BACKGROUND: The mammalian target of rapamycin (mTOR) pathway is a driver of breast tumorigenesis. The mTOR inhibitor everolimus reverses antihormonal therapy resistance and is an approved therapy for metastatic breast cancer. A synergistic effect with fluoropyrimidine has been suggested. The present study evaluated the safety and tolerability of an all-oral combination of everolimus and capecitabine for metastatic breast cancer (MBC). PATIENTS AND METHODS: MBC patients naive to capecitabine and mTOR inhibitors who had received ≤ 3 previous chemotherapy regimens in the metastatic setting were eligible for the present study...
March 16, 2017: Clinical Breast Cancer
https://www.readbyqxmd.com/read/28384214/care-of-cancer-patients-at-the-end-of-life-in-a-german-university-hospital-a-retrospective-observational-study-from-2014
#12
Burkhard Dasch, Helen Kalies, Berend Feddersen, Caecilie Ruderer, Wolfgang Hiddemann, Claudia Bausewein
BACKGROUND: Cancer care including aggressive treatment procedures during the last phase of life in patients with incurable cancer has increasingly come under scrutiny, while integrating specialist palliative care at an early stage is regarded as indication for high quality end-of-life patient care. AIM: To describe the demographic and clinical characteristics and the medical care provided at the end of life of cancer patients who died in a German university hospital...
2017: PloS One
https://www.readbyqxmd.com/read/28381416/a-phase-2-3-multicenter-randomized-open-label-study-of-lenalidomide-vs-investigator-s-choice-in-patients-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma
#13
Myron S Czuczman, Marek Trněný, Andrew Davies, Simon Aj Rule, Kim Linton, Nina Wagner-Johnston, Randy D Gascoyne, Graham Slack, Pierre Brousset, David A Eberhard, Francisco J Hernandez-Ilizaliturri, Gilles Salles, Thomas E Witzig, Pier Luigi Zinzani, George W Wright, Louis M Staudt, Yandan Yang, P Michael Williams, Chih-Jian Lih, Jacqueline Russo, Anjan Thakurta, Patrick Hagner, Pierre Fustier, Dale Song, Ian D Lewis
PURPOSE: Randomized, multicenter, open-label, phase 2/3 trial investigating lenalidomide versus investigator's choice (IC) in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). EXPERIMENTAL DESIGN: Patients with DLBCL who received ≥2 prior therapies were stratified by DLBCL subtype (germinal center B-cell [GCB] vs non-GCB; determined by immunohistochemistry [IHC]), then randomized 1:1 to lenalidomide (25 mg/day, 21 days of 28-day cycle) or IC (gemcitabine, rituximab, etoposide, or oxaliplatin)...
April 5, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28367640/toxicokinetics-and-toxicity-of-potassium-2-1-hydroxypentyl-benzoate-in-beagle-dogs
#14
Jiang Li, Xiao-Liang Wang, Ai-Ping Wang, Shao-Feng Xu, Hong-Tao Jin
Potassium 2-(1-hydroxypentyl)-benzoate (dl-PHPB) is a prodrug of 3-n-butylphthalide (dl-NBP) for treatment of cerebral ischemic stroke in China, which undergoes lactonization to form dl-NBP in plasma. And, the phase II-III clinical trial of dl-PHPB has been approved by China Food and Drug Administration (CFDA) in 2013. In this study, a toxicity and toxicokinetics evaluation of dl-PHPB was performed using beagle dogs at specially high-dose 108 mg/kg/day (65-fold higher than humans at MHRD) for 4 weeks by intravenous administration, with a 3-week recovery period...
April 2017: Journal of Asian Natural Products Research
https://www.readbyqxmd.com/read/28364597/a-new-acridine-derivative-induces-cell-cycle-arrest-and-antiangiogenic-effect-on-ehrlich-ascites-carcinoma-model
#15
Vivianne Mendes Mangueira, Tatianne Mota Batista, Monalisa Taveira Brito, Tatyanna Kelvia Gomes de Sousa, Ryldene Marques Duarte da Cruz, Renata Albuquerque de Abrantes, Robson Cavalcanti Veras, Isac Almeida de Medeiros, Karina Karla de Paula Medeiros, Ana Ligia da Costa Pereira, Vanessa de Lima Serafim, Ricardo Olímpio de Moura, Marianna Vieira Sobral
BACKGROUND: Acridine derivatives, including amsacrine, have antitumor activity. However, side effects, development of resistance and their low bioavailability, have limited their use. Herein, we described the synthesis, and evaluated the toxicity and antitumor activity of a new amsacrine analogous, the N'-(2-chloro-6-methoxy-acridin-9-yl)-2-cyano-3-(4-dimethylaminophenyl)-acrilohidrazida (ACS-AZ10). METHODS: The compound was obtained in a linear pathway where the ASC-Az intermediate was obtained by coupling of 6,9-dichloro-3-methoxy-acridine and 2-ciany-acethohidrazide followed by condensation with the corresponding aldehyde...
March 29, 2017: Biomedicine & Pharmacotherapy, Biomédecine & Pharmacothérapie
https://www.readbyqxmd.com/read/28355115/complete-hematologic-and-molecular-response-in-adult-patients-with-relapsed-refractory-philadelphia-chromosome-positive-b-precursor-acute-lymphoblastic-leukemia-following-treatment-with-blinatumomab-results-from-a-phase-ii-single-arm-multicenter-study
#16
Giovanni Martinelli, Nicolas Boissel, Patrice Chevallier, Oliver Ottmann, Nicola Gökbuget, Max S Topp, Adele K Fielding, Alessandro Rambaldi, Ellen K Ritchie, Cristina Papayannidis, Lulu Ren Sterling, Jonathan Benjamin, Anthony Stein
Purpose Few therapeutic options are available for patients with Philadelphia chromosome-positive (Ph(+)) B-precursor acute lymphoblastic leukemia (ALL) who progress after failure of tyrosine kinase inhibitor (TKI) -based therapy. Here, we evaluated the efficacy and tolerability of blinatumomab in patients with relapsed or refractory Ph(+) ALL. Patients and Methods This open-label phase II study enrolled adults with Ph(+) ALL who had relapsed after or were refractory to at least one second-generation or later TKI or were intolerant to second-generation or later TKIs and intolerant or refractory to imatinib...
March 29, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28353488/management-of-central-venous-access-device-associated-skin-impairment-an-evidence-based-algorithm
#17
Daphne Broadhurst, Nancy Moureau, Amanda J Ullman
Patients relying on central venous access devices (CVADs) for treatment are frequently complex. Many have multiple comorbid conditions, including renal impairment, nutritional deficiencies, hematologic disorders, or cancer. These conditions can impair the skin surrounding the CVAD insertion site, resulting in an increased likelihood of skin damage when standard CVAD management practices are employed. Supported by the World Congress of Vascular Access (WoCoVA), developed an evidence- and consensus-based algorithm to improve CVAD-associated skin impairment (CASI) identification and diagnosis, guide clinical decision-making, and improve clinician confidence in managing CASI...
March 28, 2017: Journal of Wound, Ostomy, and Continence Nursing
https://www.readbyqxmd.com/read/28348152/pharmacokinetics-and-tolerance-of-the-phage-endolysin-based-candidate-drug-sal200-after-a-single-intravenous-administration-among-healthy-volunteers
#18
Soo Youn Jun, In Jin Jang, Seonghae Yoon, Kyungho Jang, Kyung-Sang Yu, Joo Youn Cho, Moon-Woo Seong, Gi Mo Jung, Seong Jun Yoon, Sang Hyeon Kang
This study is a phase 1, single-center, randomized, double-blind, placebo-controlled, single-dosing, and dose-escalating study of intravenous SAL200. It is a new candidate drug for antibiotic-resistant staphylococcal infections based on a recombinant form of the phage endolysin SAL-1. The study evaluated the pharmacokinetics, pharmacodynamics, and tolerance among healthy male volunteers after the intravenous infusion of single ascending doses of SAL200 (0.1, 0.3, 1, 3, and 10 mg/kg).SAL200 was well tolerated, and no serious adverse events (AEs) were observed in this clinical study...
March 27, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28344046/long-term-outcomes-of-induction-carboplatin-and-gemcitabine-followed-by-concurrent-radiotherapy-with-low-dose-paclitaxel-and-gemcitabine-for-stage-iii-non-small-cell-lung%C3%A2-cancer
#19
Catherine Guilbault, Aurelie Garant, Sergio Faria, Scott Owen, Linda Ofiara, Marie Duclos, Vera Hirsh, Neil Kopek
BACKGROUND: Standard treatment for unresectable stage III non-small-cell lung cancer (NSCLC) is concurrent chemo-radiation (CRT). A regimen of induction carboplatin and gemcitabine followed by CRT was developed at the McGill University Health Centre to prevent delays in treatment initiation. We report the long-term outcomes with this regimen based on a pooled analysis of both protocol patients from a phase II study and nonprotocol patients. METHODS AND MATERIALS: Outcomes and toxicity data were retrieved for 142 patients with stage III NSCLC: 43 patients treated on protocol between January 2003 and November 2004, and 101 patients treated off-protocol between December 2004 and August 2013...
March 1, 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/28338993/dihydrocelastrol-inhibits-multiple-myeloma-cell-proliferation-and-promotes-apoptosis-through-erk1-2-and-il-6-stat3-pathways-in-vitro-and-in-vivo
#20
Liangning Hu, Huiqun Wu, Bo Li, Dongliang Song, Guang Yang, Gege Chen, Bingqian Xie, Zhijian Xu, Yong Zhang, Dandan Yu, Jun Hou, Wenqin Xiao, Xi Sun, Gaomei Chang, Yiwen Zhang, Lu Gao, Bojie Dai, Yi Tao, Jumei Shi, Weiliang Zhu
Multiple myeloma (MM) is the second most frequent malignant hematological disease. Dihydrocelastrol (DHCE) is synthesized by hydrogenated celastrol, a treterpene isolated from Chinese medicinal plant Tripterygium regelii. In this study, we first reported the anti-tumor activity of DHCE on MM cells. We found that DHCE could inhibit cell proliferation and promote apoptosis through caspase-dependent way in vitro. In addition, DHCE could inactivate the expression of interleukin (IL)-6 and downregulate the phosphorylation of extracellular regulated protein kinases (ERK1/2) and the signal transducer and activator of transcription 3 (STAT3) in MM...
March 17, 2017: Acta Biochimica et Biophysica Sinica
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