Full Text Journal Articles by
Author Albert Deisseroth

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Second cancers in adults with acute promyelocytic leukemia treated with or without arsenic trioxide: a SEER-medicare analysis.

Kelly J Norsworthy, Armen Avagyan, Steven T Bird, Yuchen Li, Sandia Akhtar, Jiemin Liao, Michael Wernecke, Albert B Deisseroth, Meredith Chuk, Thomas E MaCurdy, Richard Swain, Jeffrey A Kelman, Ann T Farrell, R Angelo de Claro, Richard Pazdur, Gideon Blumenthal, David J Graham,

Leukemia (Leukemia)
[2020, :]

Cited: 0 times

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Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis.

Kelly J Norsworthy, Flora Mulkey, Emma C Scott, Ashley F Ward, Donna Przepiorka, Rosane Charlab, Sarah E Dorff, Albert Deisseroth, Dickran Kazandjian, Rajeshwari Sridhara, Julia A Beaver, Ann T Farrell, R Angelo de Claro, Richard Pazdur,

PURPOSE:Differentiation syndrome (DS) is a serious adverse reaction of isocitrate dehydrogenase (IDH) inhibitors ivosidenib and enasidenib in patients with (IDH)1- and IDH2-mutated acute myeloid leukemia (AML), respectively. EXPERIMENTAL DESIGN:During FDA review of marketing applications for ivosidenib and enasidenib, data from pivotal trials were queried to identify cases of DS in ... Read more >>

Clin. Cancer Res. (Clinical cancer research : an official journal of the American Association for Cancer Research)
[2020, 26(16):4280-4288]

Cited: 0 times

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FDA Approval Summary: Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.

Donna Przepiorka, Lola Luo, Sriram Subramaniam, Junshan Qiu, Ramadevi Gudi, Lea C Cunningham, Lei Nie, Ruby Leong, Lian Ma, Christopher Sheth, Albert Deisseroth, Kirsten B Goldberg, Gideon M Blumenthal, Richard Pazdur,

On May 24, 2019, the Food and Drug Administration approved ruxolitinib for steroid-refractory acute graft-versus-host disease (SR-aGVHD) in adult and pediatric patients 12 years and older. Approval was based on Study INCB 18424-271 (REACH-1; NCT02953678), an open-label, single-arm, multicenter trial that included 49 patients with grades 2-4 SR-aGVHD occurring after allogeneic ... Read more >>

Oncologist (The oncologist)
[2020, 25(2):e328-e334]

Cited: 1 time

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FDA Approval Summary: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults.

Ruo-Jing Li, Runyan Jin, Chao Liu, Xianhua Cao, Michael L Manning, Xu Michael Di, Donna Przepiorka, Frances Namuswe, Albert Deisseroth, Kirsten B Goldberg, Gideon M Blumenthal, Richard Pazdur,

On December 20, 2018, the Food and Drug Administration approved calaspargase pegol-mknl (CALASP), an asparagine-specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years. Efficacy was determined on the basis of achievement and ... Read more >>

Clin. Cancer Res. (Clinical cancer research : an official journal of the American Association for Cancer Research)
[2020, 26(2):328-331]

Cited: 1 time

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U.S. Food and Drug Administration Benefit-Risk Assessment of Nilotinib Treatment Discontinuation in Patients with Chronic Phase Chronic Myeloid Leukemia in a Sustained Molecular Remission.

E Dianne Pulte, Tanya Wroblewski, Erik Bloomquist, Shenghui Tang, Ann Farrell, Albert Deisseroth, Amy E McKee, Richard Pazdur,

On December 22, 2017, the U.S. Food and Drug Administration (FDA) updated the product label for nilotinib to include information for providers on how to discontinue this drug in certain patients. With the updated dosing recommendations, select patients with chronic phase myeloid leukemia (CML) taking nilotinib for 3 years or ... Read more >>

Oncologist (The oncologist)
[2019, 24(5):e188-e195]

Cited: 1 time

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FDA Approval Summary: Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase-1 Mutation.

Kelly J Norsworthy, Lola Luo, Vicky Hsu, Ramadevi Gudi, Sarah E Dorff, Donna Przepiorka, Albert Deisseroth, Yuan-Li Shen, Christopher M Sheth, Rosane Charlab, Gene M Williams, Kirsten B Goldberg, Ann T Farrell, Richard Pazdur,

The FDA approved ivosidenib (Tibsovo; Agios), a small-molecule inhibitor of isocitrate dehydrogenase (IDH)1 on July 20, 2018, for treatment of adults with relapsed or refractory acute myeloid leukemia (R/R AML) with susceptible IDH1 mutation as detected by an FDA-approved test. The efficacy of ivosidenib was established on the basis of ... Read more >>

Clin. Cancer Res. (Clinical cancer research : an official journal of the American Association for Cancer Research)
[2019, 25(11):3205-3209]

Cited: 3 times

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FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease.

Emily Y Jen, Qing Xu, Aaron Schetter, Donna Przepiorka, Yuan Li Shen, Donna Roscoe, Rajeshwari Sridhara, Albert Deisseroth, Reena Philip, Ann T Farrell, Richard Pazdur,

On March 29, 2018, the FDA granted accelerated approval for blinatumomab (Blincyto; Amgen, Inc.) for the treatment of adults and children with B-cell precursor acute lymphoblastic leukemia (BCP ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Blinatumomab is a CD3xCD19 ... Read more >>

Clin. Cancer Res. (Clinical cancer research : an official journal of the American Association for Cancer Research)
[2019, 25(2):473-477]

Cited: 8 times

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Determination of Similarity Margin in Comparative Clinical Studies to Support the Development of Biosimilar Products of Neupogen® (Filgrastim, Granulocyte Colony-Stimulating Factor [G-CSF]).

Lei Nie, Donna Przepiorka, Albert Deisseroth, Rajeshwari Sridhara, Thomas E Gwise,

To demonstrate a biological product is biosimilar to a reference product, the applicant needs to show that the product is highly similar and has no clinically meaningful differences. Comparative clinical studies are often conducted to support the conclusion of no clinically meaningful differences, as a part of totality of evidence. ... Read more >>

BioDrugs (BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy)
[2018, 32(4):325-330]

Cited: 0 times

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Quantitative Relationship Between AUEC of Absolute Neutrophil Count and Duration of Severe Neutropenia for G-CSF in Breast Cancer Patients.

Liang Li, Lian Ma, Sarah J Schrieber, Nam Atiqur Rahman, Albert Deisseroth, Ann T Farrell, Yaning Wang, Vikram Sinha, Anshu Marathe,

The aim of the study was to evaluate the quantitative relationship between duration of severe neutropenia (DSN, the efficacy endpoint) and area under effect curve of absolute neutrophil counts (ANC-AUEC, the pharmacodynamic endpoint), based on data from filgrastim products, a human granulocyte colony-stimulating factor (G-CSF). Clinical data from filgrastim product ... Read more >>

Clin. Pharmacol. Ther. (Clinical pharmacology and therapeutics)
[2018, 104(4):742-748]

Cited: 1 time

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FDA Drug Approval: Elotuzumab in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma.

Nicole J Gormley, Chia-Wen Ko, Albert Deisseroth, Lei Nie, Edvardas Kaminskas, Natasha Kormanik, Kirsten B Goldberg, Ann T Farrell, Richard Pazdur,

On November 30, 2015, the FDA approved elotuzumab (Empliciti; Bristol-Myers Squibb) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who received one to three prior therapies. FDA approval was based primarily on the results of a phase III, randomized, open-label, multicenter trial, CA204004, which ... Read more >>

Clin. Cancer Res. (Clinical cancer research : an official journal of the American Association for Cancer Research)
[2017, 23(22):6759-6763]

Cited: 3 times

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Acute Myeloid Leukemia Response Measures Other Than Complete Remission.

Donna Przepiorka, Albert Deisseroth, Ann T Farrell,

J. Clin. Oncol. (Journal of clinical oncology : official journal of the American Society of Clinical Oncology)
[2015, 33(31):3675-3676]

Cited: 5 times

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FDA Approval: Blinatumomab.

Donna Przepiorka, Chia-Wen Ko, Albert Deisseroth, Carolyn L Yancey, Reyes Candau-Chacon, Haw-Jyh Chiu, Brenda J Gehrke, Candace Gomez-Broughton, Robert C Kane, Susan Kirshner, Nitin Mehrotra, Tiffany K Ricks, Deborah Schmiel, Pengfei Song, Ping Zhao, Qing Zhou, Ann T Farrell, Richard Pazdur,

On December 3, 2014, the FDA granted accelerated approval of blinatumomab (Blincyto; Amgen, Inc.) for treatment of Philadelphia chromosome-negative relapsed or refractory precursor B-cell acute lymphoblastic leukemia (R/R ALL). Blinatumomab is a recombinant murine protein that acts as a bispecific CD19-directed CD3 T-cell engager. The basis for the approval was ... Read more >>

Clin. Cancer Res. (Clinical cancer research : an official journal of the American Association for Cancer Research)
[2015, 21(18):4035-4039]

Cited: 66 times

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FDA approval: siltuximab for the treatment of patients with multicentric Castleman disease.

Albert Deisseroth, Chia-Wen Ko, Lei Nie, Jeanne F Zirkelbach, Liang Zhao, Julie Bullock, Nitin Mehrotra, Pedro Del Valle, Haleh Saber, Christopher Sheth, Brenda Gehrke, Robert Justice, Ann Farrell, Richard Pazdur,

On April 22, 2014, the FDA granted full approval to siltuximab (SYLVANT for injection; Janssen Biotech, Inc.), a chimeric human-mouse monoclonal antibody to IL6, for the treatment of patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. The approval was primarily ... Read more >>

Clin. Cancer Res. (Clinical cancer research : an official journal of the American Association for Cancer Research)
[2015, 21(5):950-954]

Cited: 28 times

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U.s. Food and Drug Administration approval: carfilzomib for the treatment of multiple myeloma.

Thomas M Herndon, Albert Deisseroth, Edvardas Kaminskas, Robert C Kane, Kallappa M Koti, Mark D Rothmann, Bahru Habtemariam, Julie Bullock, Jeffrey D Bray, Jessica Hawes, Todd R Palmby, Josephine Jee, William Adams, Houda Mahayni, Janice Brown, Angelica Dorantes, Rajeshwari Sridhara, Ann T Farrell, Richard Pazdur,

The U.S. Food and Drug Administration (FDA) review leading to accelerated approval of carfilzomib is described. A single-arm trial enrolled 266 patients with multiple myeloma refractory to the most recent therapy who had received prior treatment with bortezomib and an immunomodulatory agent (IMID). Patients received carfilzomib by intravenous infusion over ... Read more >>

Clin. Cancer Res. (Clinical cancer research : an official journal of the American Association for Cancer Research)
[2013, 19(17):4559-4563]

Cited: 91 times

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Gemtuzumab ozogamicin.

Donna Przepiorka, Albert Deisseroth, Robert Kane, Edvardas Kaminskas, Ann T Farrell, Richard Pazdur,

J. Clin. Oncol. (Journal of clinical oncology : official journal of the American Society of Clinical Oncology)
[2013, 31(13):1699-1700]

Cited: 11 times

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U.S. Food and Drug Administration approval: ruxolitinib for the treatment of patients with intermediate and high-risk myelofibrosis.

Albert Deisseroth, Edvardas Kaminskas, Joseph Grillo, Wei Chen, Haleh Saber, Hong L Lu, Mark D Rothmann, Satjit Brar, Jian Wang, Christine Garnett, Julie Bullock, Laurie B Burke, Atiqur Rahman, Rajeshwari Sridhara, Ann Farrell, Richard Pazdur,

On November 16, 2011, the U.S. Food and Drug Administration (FDA) granted full approval to ruxolitinib, (Jakafi; Incyte Corp.), an inhibitor of the Janus kinases 1 and 2, for the treatment of patients with intermediate- or high-risk myelofibrosis, including primary myelofibrosis, postpolycythemia vera myelofibrosis, and postessential thrombocythemia myelofibrosis. This approval ... Read more >>

Clin. Cancer Res. (Clinical cancer research : an official journal of the American Association for Cancer Research)
[2012, 18(12):3212-3217]

Cited: 52 times

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Toxicity of laromustine plus high-dose cytarabine in patients with relapsed acute myeloid leukemia.

Albert Deisseroth, Ann Farrell, Robert Justice, Robert Kane, Rajeshwari Sridhara, Huanyu Chen, Kun He, Richard Pazdur,

Blood (Blood)
[2010, 115(2):430]

Cited: 2 times

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Chemotherapy targeted to cancer tissue potentiates antigen-specific immune response induced by vaccine for in vivo antigen loading and activation of dendritic cells.

Hakan Akbulut, Yucheng Tang, K Gonca Akbulut, Jonathan Maynard, Albert Deisseroth,

Our laboratory has created an Ad-sig-TAA/ecdCD40L vaccine platform designed to activate dendritic cells (DCs). Two subcutaneous (s.c.) injections of the TAA/ecdCD40L protein following the s.c. injection of the Ad-sig-TAA/ecdCD40L vector (TAA/ecdCD40L VPP vaccine) further increases the levels of the tumor-associated antigen (TAA)-specific CD8 effector T cells induced by the vector. ... Read more >>

Mol. Ther. (Molecular therapy : the journal of the American Society of Gene Therapy)
[2008, 16(10):1753-1760]

Cited: 4 times

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Damage associated molecular pattern molecules.

Michael T Lotze, Albert Deisseroth, Anna Rubartelli,

Clin. Immunol. (Clinical Immunology (Orlando, Fla.))
[2007, 124(1):1-4]

Cited: 58 times

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Randomized trial of an allogeneic melanoma lysate vaccine with low-dose interferon Alfa-2b compared with high-dose interferon Alfa-2b for Resected stage III cutaneous melanoma.

Malcolm S Mitchell, Judith Abrams, John A Thompson, Mohammed Kashani-Sabet, Ronald C DeConti, Wen-Jen Hwu, Michael B Atkins, Eric Whitman, Marc S Ernstoff, Frank G Haluska, James G Jakowatz, Tapas K Das Gupta, Jon M Richards, Wolfram E Samlowski, John J Costanzi, Frederick R Aronson, Albert B Deisseroth, Arkadiusz Z Dudek, Vicky E Jones,

To compare the overall survival (OS) of patients with resected stage III melanoma administered active specific immunotherapy and low-dose interferon alfa-2b (IFN-alpha-2b) with the OS achieved using high-dose IFN-alpha-2b.An Ad Hoc Melanoma Working Group of 25 investigators treated 604 patients from April 1997 to January 2003. Patients were stratified by ... Read more >>

J. Clin. Oncol. (Journal of clinical oncology : official journal of the American Society of Clinical Oncology)
[2007, 25(15):2078-2085]

Cited: 41 times

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Endothelin-3 growth factor levels decreased in cervical cancer compared with normal cervical epithelial cells.

De Jun Sun, Ying Liu, Dong Cheng Lu, Woonbong Kim, Je Ho Lee, Jonathan Maynard, Albert Deisseroth,

We used cDNA microarray analysis of RNA extracted from normal, dysplastic, and cancerous cervical tissues to identify the changes in gene expression during the procession from normal to cancerous cervical epithelial cells. We found the expression of 5 genes in cancerous cervical epithelial cells that were not found in normal ... Read more >>

Hum. Pathol. (Human pathology)
[2007, 38(7):1047-1056]

Cited: 16 times

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Recent advances and current challenges in tumor immunology and immunotherapy.

Barbara-ann Guinn, Noriyuki Kasahara, Farzin Farzaneh, Nagy A Habib, James S Norris, Albert B Deisseroth,

Despite advances in animal studies, where the cure of the majority of mice with pre-established (albeit early-stage) tumors has become almost standard, human clinical trials have been much less successful. Here we describe some of the most recent advances in the specialist field of tumor immunology and immunotherapy, highlighting salient ... Read more >>

Mol. Ther. (Molecular therapy : the journal of the American Society of Gene Therapy)
[2007, 15(6):1065-1071]

Cited: 17 times

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Methods for delivery of adenoviral vectors to tumor vasculature.

Yanzheng Liu, James Koziol, Albert Deisseroth, Per Borgstrom,

The discovery that the luminal membrane of tumor vascular endothelial cells contains antigens different from those on the luminal membrane of endothelial cells in the vessels of normal tissues has opened the door to the use of adenoviral vectors for tumor vascular targeting as a form of cancer treatment. Other ... Read more >>

Hum. Gene Ther. (Human gene therapy)
[2007, 18(2):151-160]

Cited: 5 times

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Vector prime/protein boost vaccine that overcomes defects acquired during aging and cancer.

Yucheng Tang, Hakan Akbulut, Jonathan Maynard, Line Petersen, Xiangming Fang, Wei-Wei Zhang, Xiaoqin Xia, James Koziol, Phyllis-Jean Linton, Albert Deisseroth,

We showed that the Ad-sig-TAA/ecdCD40L vaccine induces a tumor suppressive immune response to the hMUC-1 and rH2N tumor-associated self Ags (TAA) and to the Annexin A1 tumor vascular Ag, even in mice in which anergy exists to these Ags. When the TAA/ecdCD40L protein is given s.c. as a boost following ... Read more >>

J. Immunol. (Journal of immunology (Baltimore, Md. : 1950))
[2006, 177(8):5697-5707]

Cited: 11 times

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Novel compounds with antiproliferative activity against imatinib-resistant cell lines.

Enrica I Lerma, Viet-Anh Nguyen, Tao Wang, Alex Tipping, Junia V Melo, Donald Kufe, David J Austin, Albert Deisseroth,

Chronic myelogenous leukemia is caused by the Bcr-Abl hybrid gene that encodes the p210Bcr-Abl chimeric oncoprotein. Although it reduces the total body burden of leukemia cells, the use of imatinib mesylate as a single agent may be accompanied by the evolution of resistance due mainly to the acquisition of point ... Read more >>

Mol. Cancer Ther. (Molecular cancer therapeutics)
[2007, 6(2):655-666]

Cited: 3 times

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