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Phase 3 hematology

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https://www.readbyqxmd.com/read/29772815/longitudinal-effects-of-iron-deficiency-anemia-and-subsequent-repletion-on-blood-parameters-and-the-rate-and-composition-of-growth-in-pigs
#1
Laura C Knight, Ryan N Dilger
Iron deficiency is reported as the most common nutrient deficiency worldwide. Due to rapid growth, infants are at particular risk for developing iron deficiency, which can easily progress to iron deficiency anemia (IDA), if not treated. The aim of this study was to determine the lasting effects of an early-life iron deficiency after a period of dietary iron repletion. Forty-two intact male pigs were fed, ad libitum , either control (CONT, 21.3 mg Fe/L) or iron-deficient (ID 2.72 mg Fe/L) milk replacer from postnatal day (PND) 2 to 32 (phase 1)...
May 17, 2018: Nutrients
https://www.readbyqxmd.com/read/29770997/gemcitabine-nab-paclitaxel-for-pediatric-relapsed-refractory-sarcomas
#2
Jonathan L Metts, Adina L Alazraki, Dana Clark, Ernest K Amankwah, Karen J Wasilewski-Masker, Bradley A George, Thomas A Olson, Thomas Cash
BACKGROUND: Pediatric patients with relapsed/refractory sarcomas have poor outcomes and need novel therapies that provide disease control while maintaining an acceptable quality of life. The activity and toxicity of gemcitabine and nab-paclitaxel in combination has not been reported in pediatrics. PROCEDURE: We reviewed the records of fifteen relapsed/refractory patients and one treatment-naïve patient who received gemcitabine/nab-paclitaxel at our institution...
May 17, 2018: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/29769385/phase-ii-study-of-irinotecan-plus-panitumumab-as-second-line-therapy-for-patients-with-advanced-esophageal-adenocarcinoma
#3
Harry Yoon, Anita Choudhary, Ramla Kosozi, Gurvinder Singh Bali, Ali Zaidi, Ajlan Atasoy, Arlene A Forastiere, Michael K Gibson
LESSON LEARNED: Panitumumab plus irinotecan is not active for the treatment of esophageal adenocarcinoma. BACKGROUND: Esophageal adenocarcinoma (EAC) is a lethal cancer with increasing incidence. Panitumumab (Pa) is a fully humanized IgG2 monoclonal antibody against human EGFR. Cetuximab (Cx) combined with irinotecan (Ir) is active for second-line treatment of colorectal cancer. This phase II study was designed to evaluate Pa plus Ir as second-line therapy for advanced EAC...
May 16, 2018: Oncologist
https://www.readbyqxmd.com/read/29765547/signature-program-a-platform-of-basket-trials
#4
Eric D Slosberg, Barinder P Kang, Julio Peguero, Matthew Taylor, Todd M Bauer, Donald A Berry, Fadi Braiteh, Alexander Spira, Funda Meric-Bernstam, Steven Stein, Sarina A Piha-Paul, August Salvado
Investigating targeted therapies can be challenging due to diverse tumor mutations and slow patient accrual for clinical studies. The Signature Program is a series of 8 phase 2, agent-specific basket protocols using a rapid study start-up approach involving no predetermined study sites. Each protocol evaluated 1 agent (buparlisib, dovitinib, binimetinib, encorafenib, sonidegib, BGJ398, ceritinib, or ribociclib) in patients with solid or hematologic malignancies and an actionable mutation. The primary endpoint of each study was the clinical benefit rate (ie, complete or partial response, or stable disease) at 16 weeks...
April 20, 2018: Oncotarget
https://www.readbyqxmd.com/read/29753611/neo-adjuvant-platinum-based-chemotherapy-followed-by-chemoradiation-and-radical-surgery-in-locally-advanced-cervical-cancer-lacc-patients-a-phase-ii-study
#5
Gabriella Ferrandina, Eleonora Palluzzi, Valerio Gallotta, Maria Antonietta Gambacorta, Rosa Autorino, Luigi Carlo Turco, Gabriella Macchia, Francesco Cosentino, Benedetta Gui, Maria Vittoria Mattoli, Graziana Ronzino, Vincenzo Valentini, Giovanni Scambia
PURPOSE: The aim of this Phase II, non-randomized study was to assess activity and safety of neoadjuvant chemotherapy (NACT) before chemoradiation (CT/RT) followed by radical surgery (RS) in locally advanced cervical cancer (LACC) patients. METHODS AND MATERIALS: The primary end point was rate of pathologic complete response (pCR). FIGO Stage IB2-IVA patients were administered NACT chemotherapy (paclitaxel 80 mg/m2 , carboplatin AUC 2), for 6 weeks, followed by Intensity Modulated Radiotherapy plus simultaneous boost (total dose of 50...
May 3, 2018: European Journal of Surgical Oncology
https://www.readbyqxmd.com/read/29750040/a-phase-ib-study-of-ruxolitinib-gemcitabine-%C3%A2-nab-paclitaxel-in-patients-with-advanced-solid-tumors
#6
Todd M Bauer, Manish R Patel, Andres Forero-Torres, Thomas J George, Albert Assad, Yining Du, Herbert Hurwitz
Purpose: Aberrant activation of the Janus-associated kinase (JAK)/signal transducer and activator of transcription (STAT) pathway is associated with increased malignant cell proliferation and survival. This Phase Ib study evaluated ruxolitinib, a potent JAK1/2 inhibitor, in combination with gemcitabine with or without nab-paclitaxel in patients with advanced solid tumors. Patients and methods: Patients received ruxolitinib + gemcitabine (regimen A) or ruxolitinib + gemcitabine + nab-paclitaxel (regimen B)...
2018: OncoTargets and Therapy
https://www.readbyqxmd.com/read/29750016/spotlight-on-isavuconazole-in-the-treatment-of-invasive-aspergillosis-and-mucormycosis-design-development-and-place-in-therapy
#7
REVIEW
Jeffrey D Jenks, Helmut Jf Salzer, Juergen Prattes, Robert Krause, Dieter Buchheidt, Martin Hoenigl
In recent decades, important advances have been made in the diagnosis and treatment of invasive aspergillosis (IA) and mucormycosis. One of these advances has been the introduction of isavuconazole, a second-generation broad spectrum triazole with a favorable pharmacokinetic and safety profile and few drug-drug interactions. Phase III trials in patients with IA and mucormycosis demonstrated that isavuconazole has similar efficacy to voriconazole for the treatment of IA (SECURE trial) and liposomal amphotericin B for the treatment of mucormycosis (VITAL trial with subsequent case-control analysis) and a favorable safety profile with significantly fewer ocular, hepatobiliary, and skin and soft tissue adverse events compared to voriconazole...
2018: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29748444/rituximab-plus-bendamustine-as-front-line-treatment-in-frail-elderly-70-years-patients-with-diffuse-large-b-cell-non-hodgkin-s-lymphoma-a-phase-ii-multicenter-study-of-the-fondazione-italiana-linfomi
#8
Sergio Storti, Michele Spina, Emanuela Anna Pesce, Flavia Salvi, Michele Merli, Alessia Ruffini, Giuseppina Cabras, Annalisa Chiappella, Emanuele Angelucci, Alberto Fabbri, Anna Marina Liberati, Monica Tani, Gerardo Musuraca, Annalia Molinari, Maria Pia Petrilli, Carmela Palladino, Rosanna Ciancia, Andrea Ferrario, Cristiana Gasbarrino, Federico Monaco, Vincenzo Fraticelli, Annalisa De Vellis, Francesco Merli, Stefano Luminari
We conducted a phase II study to assess activity and safety profile of bendamustine and rituximab in elderly patients with untreated Diffuse Large B Cell Lymphoma who were prospectively defined as frail using a simplified version of a Comprehensive Geriatric Assessment. Patients had to be > 70 years of age, with histologically confirmed Diffuse Large B Cell Lymphoma. Frail patients were those younger than 80 years with a frail profile at Comprehensive Geriatric Assessment or older than 80 years with an unfit profile...
May 10, 2018: Haematologica
https://www.readbyqxmd.com/read/29748443/a-phase-2-multicenter-study-of-the-anti-cd19-antibody-drug-conjugate-coltuximab-ravtansine-sar3419-in-patients-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-previously-treated-with-rituximab-based-immunotherapy
#9
Marek Trněný, Gregor Verhoef, Martin Js Dyer, Dina Ben Yehuda, Caterina Patti, Miguel Canales, Andrés Lopez, Farrukh T Awan, Paul G Montgomery, Andrea Janikova, Anna M Barbui, Kazimierz Sulek, Maria J Terol, John Radford, Anna Guidetti, Massimo Di Nicola, Laure Siraudin, Laurence Hatteville, Sandrine Schwab, Corina Oprea, Alessandro M Gianni
This phase 2, single-arm, multicenter study examined the efficacy and safety of coltuximab ravtansine (an anti-CD19 antibody drug conjugate) in 61 patients with histologically documented (de novo or transformed) relapsed or refractory diffuse large B-cell lymphoma who had previously received rituximab containing immuno-chemotherapy. Patients had received a median of 2.0 (range 0-9) prior treatment regimens for diffuse large B-cell lymphoma and almost half (45.9%) had bulky disease (≥ lesion >5 cm) at trial entry...
May 10, 2018: Haematologica
https://www.readbyqxmd.com/read/29748012/a-phase-i-study-of-nintedanib-combined-with-cisplatin-gemcitabine-as-first-line-therapy-for-advanced-squamous-non-small-cell-lung-cancer-lume-lung-3
#10
Martin Forster, Allan Hackshaw, Tommaso De Pas, Manuel Cobo, Pilar Garrido, Yvonne Summers, Anne-Marie C Dingemans, Michael Flynn, David Schnell, Ute von Wangenheim, Arsene-Bienvenu Loembé, Rolf Kaiser, Siow Ming Lee
BACKGROUND: There are limited treatment options for squamous non-small cell lung cancer (sqNSCLC) and prognosis remains poor. The safety and pharmacokinetics (PK) of nintedanib, a triple angiokinase inhibitor, plus cisplatin/gemcitabine as first-line treatment for advanced sqNSCLC patients, were evaluated. MATERIALS AND METHODS: A phase I, dose-escalation study administering drugs in a 21-day cycle: cisplatin (75 mg/m2 , Day 1), gemcitabine (1250 mg/m2 , Days 1 and 8) and nintedanib (Days 2-7, 9-21) were given for 4-6 cycles, followed by monotherapy until disease progression or adverse events (AEs)...
June 2018: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/29744672/efficacy-and-safety-of-neoadjuvant-treatment-with-bevacizumab-liposomal-doxorubicin-cyclophosphamide-and-paclitaxel-combination-in-locally-regionally-advanced-her2-negative-grade-iii-at-premenopausal-status-breast-cancer-a-phase-ii-study
#11
Ekaterini C Tampaki, Athanasios Tampakis, Constantinos E Alifieris, Dimitrios Krikelis, Anastasia Pazaiti, Michalis Kontos, Dimitrios T Trafalis
BACKGROUND: In the era of personalized therapy, targeted treatment in specific patient populations is mandated. OBJECTIVE: We evaluated the efficacy and safety of neoadjuvant treatment on locally advanced breast cancer (LABC) with a monoclonal agent against vascular endothelial growth factor (VEGF), bevacizumab plus chemotherapy combination of liposomal doxorubicin, cyclophosphamide and paclitaxel (PLAC-B). METHODS: Patients enrolled were at premenopausal status and characterized by human epidermal growth factor receptor 2 (HER2)-negative, hormone-receptor positive (estrogen receptor/progesterone receptor-positive [ER/PR+]) or triple-negative (TNBC), LABC (T > 3 cm), with high-grade ductal carcinoma...
May 9, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29743140/a-phase-i-single-arm-open-label-dose-escalation-study-of-intraperitoneal-cisplatin-and-doxorubicin-in-patients-with-recurrent-ovarian-cancer-and-peritoneal-carcinomatosis
#12
Clemens B Tempfer, Urs Giger-Pabst, Veronika Seebacher, Miriam Petersen, Askin Dogan, Günther A Rezniczek
OBJECTIVE: We performed a phase I, single-arm, non-randomized, open-label, dose-escalation trial to determine the dose-limiting toxicity of intraperitoneal cisplatin and doxorubicin applied as pressurized intraperitoneal aerosol chemotherapy (PIPAC) in women with recurrent ovarian cancer. METHODS: We used a standard 3 + 3 dose-escalation design with doxorubicin 1.5 mg/m2 , cisplatin 7.5 mg/m2 q 4 to 6 weeks for 3 cycles and subsequent dose escalation steps (20% increment per step) in patients with recurrent ovarian cancer and peritoneal carcinomatosis...
May 6, 2018: Gynecologic Oncology
https://www.readbyqxmd.com/read/29733771/phase-ib-trial-with-birabresib-a-small-molecule-inhibitor-of-bromodomain-and-extraterminal-proteins-in-patients-with-selected-advanced-solid-tumors
#13
Jeremy Lewin, Jean-Charles Soria, Anastasios Stathis, Jean-Pierre Delord, Solange Peters, Ahmad Awada, Philippe G Aftimos, Mohamed Bekradda, Keyvan Rezai, Zhen Zeng, Azher Hussain, Susan Perez, Lillian L Siu, Christophe Massard
Purpose Birabresib (MK-8628/OTX015) is a first-in-class bromodomain inhibitor with activity in select hematologic tumors. Safety, efficacy, and pharmacokinetics of birabresib were evaluated in patients with castrate-resistant prostate cancer, nuclear protein in testis midline carcinoma (NMC), and non-small-cell lung cancer in this phase Ib study. Patients and Methods Forty-seven patients were enrolled to receive birabresib once daily at starting doses of 80 mg continuously (cohort A) or 100 mg for 7 consecutive days (cohort B) in 21-day cycles using a parallel dose escalation 3 + 3 design...
May 7, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29728800/phase-ii-trial-of-induction-chemotherapy-of-pemetrexed-plus-split-dose-cisplatin-followed-by-pemetrexed-maintenance-for-untreated-non-squamous-non-small-cell-lung-cancer
#14
Taro Koba, Seigo Minami, Yu Nishijima-Futami, Kentaro Masuhiro, Hiromi Kimura, Shinji Futami, Moto Yaga, Masahide Mori, Hiroyuki Kagawa, Takeshi Uenami, Satoshi Kohmo, Tomoyuki Otsuka, Suguru Yamamoto, Kiyoshi Komuta, Takashi Kijima
PURPOSE: We conducted a phase II trial to evaluate the efficacy and safety of induction chemotherapy of pemetrexed plus split-dose cisplatin followed by pemetrexed maintenance for advanced non-squamous non-small-cell lung cancer (NSCLC). METHODS: Patients with advanced or recurrent untreated non-squamous NSCLC received split-dose cisplatin (40 mg/m2 , days 1 and 8) plus pemetrexed (500 mg/m2 , day 1) tri-weekly. After four cycles of induction, patients without disease progression received pemetrexed maintenance until disease progression or unacceptable toxicity...
May 4, 2018: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29715056/venetoclax-for-patients-with-chronic-lymphocytic-leukemia-with-17p-deletion-results-from-the-full-population-of-a-phase-ii-pivotal-trial
#15
Stephan Stilgenbauer, Barbara Eichhorst, Johannes Schetelig, Peter Hillmen, John F Seymour, Steven Coutre, Wojciech Jurczak, Stephen P Mulligan, Anna Schuh, Sarit Assouline, Clemens-Martin Wendtner, Andrew W Roberts, Matthew S Davids, Johannes Bloehdorn, Talha Munir, Sebastian Böttcher, Lang Zhou, Ahmed Hamed Salem, Monali Desai, Brenda Chyla, Jennifer Arzt, Su Young Kim, Maria Verdugo, Gary Gordon, Michael Hallek, William G Wierda
Purpose Venetoclax is an orally bioavailable B-cell lymphoma 2 inhibitor. US Food and Drug Administration and European Medicines Agency approval for patients with 17p deleted relapsed/refractory chronic lymphocytic leukemia [del(17p) CLL] was based on results from 107 patients. An additional 51 patients were enrolled in a safety expansion cohort. Extended analysis of all enrolled patients, including the effect of minimal residual disease (MRD) negativity on outcome, is now reported. Patients and Methods Overall, 158 patients with relapsed/refractory or previously untreated (n = 5) del(17p) CLL received venetoclax 400 mg per day after an initial dose ramp up...
May 1, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29709062/management-of-newly-diagnosed-high-risk-and-intermediate-risk-follicular-lymphoma-with-90-y-ibritumomab-tiuxetan-in-a-phase-ii-study
#16
Neil L Berinstein, Nancy M Pennell, Rashmi Weerasinghe, Rena Buckstein, Eugenia Piliotis, Kevin R Imrie, Lisa Chodirker, Mary-Anne Cussen, Ellen Miles, Marciano D Reis, Zeina Ghorab, Matthew C Cheung
Five-year overall survival for high-risk Follicular Lymphoma International Prognostic Index follicular lymphoma is only approximately 50% compared with 90% for low risk. To evaluate an approach to improve upon this poor outcome, we completed an exploratory phase II trial of intensified treatment for patients with intermediate and high-risk follicular lymphoma. Front-line treatment with chemo-immunotherapy consisting of rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone was followed by radio- immunotherapy with 90-Yttrium ibritumomab tiuxetan consolidation, and 2 years of rituximab maintenance...
April 30, 2018: Hematological Oncology
https://www.readbyqxmd.com/read/29708270/acute-acalculous-cholecystitis-in-hospitalized-patients-with-hematologic-malignancies-and-prognostic-importance-of-gallbladder-ultrasound-findings
#17
Rajesh Thampy, Ahmad Khan, Islam H Zaki, Wei Wei, Brinda Rao Korivi, Greg Staerkel, Tharakeswara K Bathala
OBJECTIVES: Patients with hematologic malignancies, especially those with acute disease or those receiving intense chemotherapy, are known to develop acute acalculous cholecystitis (AAC). The aim of this study was to evaluate the diagnostic and prognostic value of the established ultrasound (US) diagnostic criteria for AAC in patients with acute hematologic malignancies who were clinically suspected to have AAC. METHODS: We retrospectively studied the US findings of the gallbladder in patients with hematologic malignancies and correlated these findings with the duration of clinical symptoms, complications, and gallbladder-specific mortality...
April 30, 2018: Journal of Ultrasound in Medicine: Official Journal of the American Institute of Ultrasound in Medicine
https://www.readbyqxmd.com/read/29707140/a-phase-1-study-of-lirilumab-antibody-against-killer-immunoglobulin-like-receptor-antibody-kir2d-iph2102-in-patients-with-solid-tumors-and-hematologic-malignancies
#18
Norbert Vey, Lionel Karlin, Sophie Sadot-Lebouvier, Florence Broussais, Dominique Berton-Rigaud, Jérôme Rey, Aude Charbonnier, Delphine Marie, Pascale André, Carine Paturel, Robert Zerbib, Jaafar Bennouna, Gilles Salles, Anthony Gonçalves
Purpose: Anti-KIR monoclonal antibodies (mAbs) can enhance the antitumor responses of natural killer (NK) cells. We evaluated the safety of the anti-KIR2D mAb lirilumab in patients with various cancers. Experimental design: Thirty-seven patients with hematological malignancies ( n = 22) or solid tumors ( n = 15) were included in the study. Dose escalation (0.015 to 10 mg/kg) was conducted following a 3 + 3 design. Patients were scheduled to receive four cycles of treatment...
April 3, 2018: Oncotarget
https://www.readbyqxmd.com/read/29702996/phase-i-study-of-cord-blood-transplantation-with-intrabone-marrow-injection-of-mesenchymal-stem-cells-a-clinical-study-protocol
#19
Tatsunori Goto, Makoto Murata, Seitaro Terakura, Tetsuya Nishida, Yoshiya Adachi, Yoko Ushijima, Kazuyuki Shimada, Yuichi Ishikawa, Fumihiko Hayakawa, Nobuhiro Nishio, Satoshi Nishiwaki, Akihiro Hirakawa, Katsuyoshi Kato, Yoshiyuki Takahashi, Hitoshi Kiyoi
INTRODUCTION: Delayed hematological recovery, graft failure, and acute graft-versus-host disease (GVHD) still remain major problems in cord blood transplantation (CBT). Mesenchymal stem cells (MSCs) are known to support bone marrow stroma and promote hematopoiesis. Additionally, MSCs possess immunomodulatory properties and are used clinically for the treatment of acute GVHD. Therefore, the use of MSCs to enhance engraftment and prevent GVHD after allogeneic hematopoietic cell transplantation has been explored...
April 2018: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29697933/comparison-of-inflammatory-markers-between-brucella-and-non-brucella-epididymo-orchitis
#20
Ali Cift, Mehmet Ozgur Yucel
OBJECTIVES: Brucellosis is a multi-system infectious disease that is associated with inflammation, which causes an increase in acute phase reactants. Hematological inflammatory markers of brucellosis include mean platelet volume (MPV), red cell distribution width (RDW), neutrophil/lymphocyte ratio (NLR), and platelet/lymphocyte ratio (PLR). In this study, we aimed to evaluate the diagnostic value of hematological inflammatory markers in Brucella epididymo-orchitis (BEO), and to investigate the utility of these markers for differential diagnosis from non-Brucella epididymo-orchitis (non-BEO)...
April 15, 2018: International Braz J Urol: Official Journal of the Brazilian Society of Urology
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