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https://www.readbyqxmd.com/read/29223388/transplantation-in-the-treatment-of-primary-cutaneous-aggressive-epidermotropic-cytotoxic-cd8-positive-t-cell-lymphoma
#1
Benoit M Cyrenne, Juliet Fraser Gibson, Antonio Subtil, Michael Girardi, Iris Isufi, Stuart Seropian, Francine Foss
BACKGROUND: Primary cutaneous aggressive epidermotropic cytotoxic CD8 positive T-cell lymphoma (CD8+ PCAETL) is a rare subtype of peripheral T-cell lymphoma with poor outcomes and without a standardized treatment strategy. Allogeneic hematopoietic stem cell transplantation (HSCT) has been suggested as a potential curative therapy. PATIENTS AND METHODS: We conducted a retrospective case series. We identified 8 patients with the diagnosis of CD8+ PCAETL, 4 of whom also underwent allogeneic HSCT...
December 6, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/29191068/an-exploratory-cost-effectiveness-analysis-of-systemic-treatments-for-cutaneous-t-cell-lymphoma
#2
Larisa Geskin, Daniel C Malone
PURPOSE: To conduct an exploratory cost-effectiveness analysis of systemic treatment options for more advanced cutaneous T-cell lymphoma (CTCL). METHODS: A cost-effectiveness model compared systemic bexarotene, denileukin diftitox, interferon alpha, methotrexate, pralatrexate, romidepsin, vorinostat, and extracorporeal photopheresis (ECP) treatment of CTCL. Treatment effectiveness data were extracted from published studies and/or US product labeling. Overall response, the primary effectiveness measure, was defined as the proportion of patients achieving complete or partial response...
December 1, 2017: Journal of Dermatological Treatment
https://www.readbyqxmd.com/read/29141948/a-phase-i-study-of-romidepsin-and-pralatrexate-reveals-marked-activity-in-relapsed-and-refractory-t-cell-lymphoma
#3
Jennifer E Amengual, Renee Lichtenstein, Jennifer Lue, Ahmed Sawas, Changchun Deng, Emily Lichtenstein, Karen Khan, Laine Atkins, Aishling Rada, Hye A Kim, Codruta Chiuzan, Matko Kalac, Enrica Marchi, Lorenzo Falchi, Mark A Francescone, Lawrence Schwartz, Serge Cremers, Owen A O'Connor
The peripheral T-cell lymphomas (PTCL) are a group of rare malignancies characterized by chemotherapy insensitivity and poor prognosis. Romidepsin and pralatrexate were approved by the U.S. FDA for patients with relapsed/refractory PTCL, exhibiting response rates of 25% and 29% respectively. Based on synergy of the combination in preclinical models of PTCL, we initiated a phase I study of pralatrexate plus romidepsin in patients with relapsed/refractory lymphoma (ClinicalTrials.gov (NCT01947140)). This was a single institution dose-escalation phase I study of pralatrexate plus romidepsin designed to determine the dose limiting toxicities (DLT), maximum tolerated dose (MTD), pharmacokinetic profile and response rates...
November 15, 2017: Blood
https://www.readbyqxmd.com/read/28946015/peripheral-t-cell-lymphomas-focusing-on-novel-agents-in-relapsed-and-refractory-disease
#4
REVIEW
Alessandro Broccoli, Lisa Argnani, Pier Luigi Zinzani
Patients with relapsed or refractory peripheral T-cell lymphoma display a dismal prognosis and their therapy represents an unmet medical need, as the best treatment strategy is yet to be determined. Exciting data on novel targeted agents are now emerging from recently concluded and ongoing clinical trials in patients with relapsed and refractory PTCL. Four recently approved compounds are used as single agents: pralatrexate, a novel antifolate agent; romidepsin and belinostat, both histone deacetylase (HDAC) inhibitors; brentuximab vedotin, an anti-CD30 drug-conjugated monoclonal antibody...
November 2017: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/28771889/phase-i-ii-study-of-pralatrexate-in-japanese-patients-with-relapsed-or-refractory-peripheral-t-cell-lymphoma
#5
MULTICENTER STUDY
Dai Maruyama, Hirokazu Nagai, Yoshinobu Maeda, Takahiko Nakane, Tatsu Shimoyama, Tomonori Nakazato, Rika Sakai, Takayuki Ishikawa, Koji Izutsu, Ryuzo Ueda, Kensei Tobinai
Pralatrexate is a novel antifolate approved in the USA for the treatment of relapsed or refractory peripheral T-cell lymphoma. To assess its safety, efficacy, and pharmacokinetics in Japanese patients with this disease, we undertook a phase I/II study. Pralatrexate was given i.v. weekly for 6 weeks of a 7-week cycle. All patients received concurrent vitamin B12 and folic acid. In phase I, three patients received pralatrexate 30 mg/m(2) and none experienced a dose-limiting toxicity. In phase II, we treated 22 additional patients with that dose...
October 2017: Cancer Science
https://www.readbyqxmd.com/read/28738754/pralatrexate-a-comprehensive-update-on-pharmacology-clinical-activity-and-strategies-to-optimize-use
#6
Owen A O'Connor, Jennifer Amengual, Donald Colbourn, Changchun Deng, Ahmed Sawas
It has been nearly 8 years since pralatrexate became the first drug approved by the U.S. Food and Drug Administration for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL). Like most drugs approved for a particular clinical indication, as much or more is learned once it enters mainstream use as in the years leading up to regulatory approval. Over the past several years, many diverse lines of research have shed new insight into both the agent, and the diseases it treats. In this review, we will bring the reader up to date on the many new aspects related to pralatrexate's pharmacology, activity across the panoply of T-cell lymphoproliferative malignancies, as well as some new and emerging guidelines that are likely to improve its safety profile...
November 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28649848/mogamulizumab-for-the-treatment-of-t-cell-lymphoma
#7
Shinichi Makita, Kensei Tobinai
T-cell lymphoma is a relatively rare hematologic malignancy that accounts for 10-20% of non-Hodgkin lymphomas. Treatment strategies for T-cell lymphomas are different from that for B-cell lymphomas and have poor prognoses. Among various subtypes of T-cell lymphomas, adult T-cell leukemia-lymphoma (ATL) has the worst prognosis. To achieve further improvement in the treatment outcome of T-cell lymphomas, several novel agents such as brentuximab vedotin, lenalidomide, romidepsin, and pralatrexate are actively being studied...
September 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28340883/novel-agents-in-the-treatment-of-relapsed-or-refractory-peripheral-t-cell-lymphoma
#8
REVIEW
Enrica Marchi, Alexander G Raufi, Owen A O'Connor
Peripheral T-cell lymphomas (PTCL) are a heterogeneous group of mature T-cell malignancies associated with exceptionally poor prognoses. Currently, chemotherapy remains the standard of care, but outcomes are suboptimal, with 5-year survival rates ranging from 15% to 25%. In recent years, several novel agents, including pralatrexate, romidepsin, belinostat, and brentuximab vedotin, have been approved for the treatment of relapsed/refractory PTCL. In addition, numerous other therapies with different mechanisms of action and targets are currently under investigation...
April 2017: Hematology/oncology Clinics of North America
https://www.readbyqxmd.com/read/28167509/results-from-a-phase-i-ii-open-label-dose-finding-study-of-pralatrexate-and-oral-bexarotene-in-patients-with-relapsed-refractory-cutaneous-t-cell-lymphoma
#9
Madeleine Duvic, Youn H Kim, Pier Luigi Zinzani, Steven M Horwitz
Purpose: Pralatrexate is a folic acid analogue metabolic inhibitor similar to methotrexate, which has shown tolerability and efficacy with an overall response rate of 45% in a phase I dose deescalation study of patients with relapsed/refractory cutaneous T-cell lymphoma (CTCL).Experimental Design: The object of this phase I/II open-label, multicenter clinical trial was to determine the MTD and recommended dose of pralatrexate plus oral bexarotene in 34 patients with relapsed/refractory CTCL who had failed prior systemic therapies...
July 15, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28115372/peripheral-t-cell-lymphoma-not-otherwise-specified
#10
REVIEW
Alessandro Broccoli, Pier Luigi Zinzani
Peripheral T-cell lymphoma, not otherwise specified, is a broad category of biologically and clinically heterogeneous diseases that cannot be further classified into any other of the existing entities defined by the World Health Organization classification. Anthracycline-containing regimens, namely cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), nowadays represent the standard first-line treatment; for patients who achieve a satisfactory response, a consolidation by means of autologous stem cell transplantation may offer a greater chance of long-term survival...
March 2, 2017: Blood
https://www.readbyqxmd.com/read/27983760/the-survival-outcome-of-patients-with-relapsed-refractory-peripheral-t-cell-lymphoma-not-otherwise-specified-and-angioimmunoblastic-t-cell-lymphoma
#11
Dai Chihara, Michelle A Fanale, Roberto N Miranda, Mansoor Noorani, Jason R Westin, Loretta J Nastoupil, Fredrick B Hagemeister, Luis E Fayad, Jorge E Romaguera, Felipe Samaniego, Francesco Turturro, Hun J Lee, Sattva S Neelapu, M Alma Rodriguez, Michael Wang, Nathan H Fowler, Richard E Davis, L Jeffrey Medeiros, Chitra Hosing, Yago L Nieto, Yasuhiro Oki
Survival outcome of patients with peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) and angioimmunoblastic T-cell lymphoma (AITL) who experience disease progression/relapse remains very poor. A total of 321 patients, newly diagnosed with PTCL-NOS (n = 180) or AITL (n = 141) between 1999 and 2015, were analysed. Failure-free survival (FFS) and overall survival (OS) were calculated from the time of first disease progression (FFS1, OS1), from second disease progression (FFS2, OS2) and from third progression (FFS3, OS3)...
March 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/27643862/identification-and-characterization-of-forced-degradation-products-of-pralatrexate-injection-by-lc-pda-and-lc-ms
#12
R V R Prabhakara Sastry, C S Venkatesan, B S Sastry, K Mahesh
Pralatrexate (PTXT) is an antineoplastic folate analog and the chemical name is (2S)-2-[[4-[(1RS)-1-[(2,4-diaminopteridin-6-yl)methyl]but-3-ynyl] benzoyl] amino] pentanedioic acid. Degradation products of PTXT drug product (DP) under different forced degradation conditions have been studied using LC-PDA and LC-MS techniques. PTXT DP was subjected to forced degradation under the conditions of hydrolysis, photolysis, oxidation, and heat in accordance with ICH guidelines. The LC-MS compatible HPLC method was developed and stressed solutions were chromatographed on reversed phase HPLC...
November 30, 2016: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/27638045/phase-1-study-evaluating-the-safety-and-pharmacokinetics-of-pralatrexate-in-relapsed-refractory-advanced-solid-tumors-and-lymphoma-patients-with-mild-moderate-and-severe-renal-impairment
#13
Kevin R Kelly, Nashat Gabrail, Steven Weitman, John Sarantopoulos, Anthony J Olszanski, William Edenfield, Jurgen Venitz, Guru Reddy, Allen Yang, Steven J Hasal, A Craig Lockhart
PURPOSE: Pralatrexate is a folate analogue indicated for the treatment of relapsed or refractory peripheral T-cell lymphoma. It has not been formally tested in patients with renal impairment. This study evaluated the pharmacokinetic (PK) profile of pralatrexate in patients with renal impairment and with relapsed/refractory advanced solid tumors and lymphoma. METHODS: This was an open-label, nonrandomized, phase 1 study. Eligible patients received pralatrexate administered as an IV push over 3-5 min once weekly for 6 weeks in 7-week cycles until progressive disease or intolerable toxicity...
November 2016: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/27421044/phase-1-and-2-study-of-carboplatin-and-pralatrexate-in-patients-with-recurrent-platinum-sensitive-ovarian-fallopian-tube-or-primary-peritoneal-cancer
#14
Marcela G Del Carmen, Jeff G Supko, Nora K Horick, J Alejandro Rauh-Hain, Rachel M Clark, Susana M Campos, Carolyn N Krasner, Tina Atkinson, Michael J Birrer
BACKGROUND: The objective of this phase 1 and 2 trial was to identify the appropriate dose of combined carboplatin and pralatrexate for patients with recurrent, platinum-sensitive ovarian, fallopian tube, and primary peritoneal cancer. METHODS: In phase 1, patients received carboplatin (at an area under the curve of 5) and increasing doses of pralatrexate until the maximum-tolerated dose (MTD) of pralatrexate was achieved. The primary endpoint was the response rate...
November 15, 2016: Cancer
https://www.readbyqxmd.com/read/27366017/pralatrexate-in-combination-with-bortezomib-for-relapsed-or-refractory-peripheral-t-cell-lymphoma-in-5-elderly-patients
#15
Seung-Shin Lee, Sung-Hoon Jung, Jae-Sook Ahn, Yeo-Kyeoung Kim, Min-Seok Cho, Seung-Yeon Jung, Je-Jung Lee, Hyeoung-Joon Kim, Deok-Hwan Yang
Peripheral T cell lymphoma (PTCL) is a heterogeneous group of aggressive lymphomas with poor prognosis. Elderly (age ≥ 65years) patients generally have impaired bone marrow function, altered drug metabolism, comorbidities, and poor functional status. Thus, treatment of elderly patients with relapsed or refractory PTCL remains a challenge for clinicians. A recent study disclosed that pralatrexate has a synergistic effect in combination with bortezomib. Weekly pralatrexate and bortezomib were administered intravenously for 3 weeks in a 4-week cycle...
July 2016: Journal of Korean Medical Science
https://www.readbyqxmd.com/read/27040320/a-phase-1-open-label-dose-escalation-study-of-pralatrexate-in%C3%A2-combination-with-bortezomib-in-patients-with-relapsed-refractory-multiple-myeloma
#16
Tamara J Dunn, Shira Dinner, Elizabeth Price, Steven E Coutré, Jason Gotlib, Ying Hao, Caroline Berube, Bruno C Medeiros, Michaela Liedtke
Pralatrexate inhibits folic acid metabolism, and preclinical studies have shown that it is cytotoxic to multiple myeloma cells. This phase 1 study investigated the safety and efficacy of pralatrexate in combination with bortezomib in adults with relapsed or refractory multiple myeloma. A standard 3 + 3 design was used. Patients received intravenous pralatrexate at doses ranging from 10 to 30 mg/m(2) and intravenous bortezomib at a dose of 1·3 mg/m(2) on days 1, 8 and 15 of each 4-week cycle. Eleven patients were enrolled and completed a median of two cycles...
April 2016: British Journal of Haematology
https://www.readbyqxmd.com/read/26811013/panoptic-clinical-review-of-the-current-and-future-treatment-of-relapsed-refractory-t-cell-lymphomas-peripheral-t-cell-lymphomas
#17
REVIEW
Pier Luigi Zinzani, Vijayveer Bonthapally, Dirk Huebner, Richard Lutes, Andy Chi, Stefano Pileri
Peripheral T-cell lymphomas (PTCLs) tend to be aggressive and chemorefractory, with about 70% of patients developing relapsed/refractory disease. Prior to 2009, chemotherapies were the only options for relapsed/refractory PTCL, other than hematopoietic transplants. However, chemotherapy only improves survival by about 1 month compared with palliation. Four drugs are now approved in the US to treat relapsed/refractory PTCL: pralatrexate, romidepsin, belinostat, and brentuximab vedotin (for systemic anaplastic large cell lymphoma [sALCL])...
March 2016: Critical Reviews in Oncology/hematology
https://www.readbyqxmd.com/read/26809959/pralatrexate-monitoring-using-a-commercially-available-methotrexate-assay-to-avoid-potential-drug-interactions
#18
Jordan P McPherson, Alaina Vrontikis, Courtney Sedillo, Ahmad S Halwani, Jeffrey A Gilreath
Pralatrexate (PDX) is a folate antagonist structurally similar to methotrexate (MTX). Unlike MTX, it is currently not known whether PDX exhibits delayed clearance and heightened toxicity in the setting of fluid overload. A specific serum assay for PDX is not commercially available. To our knowledge, we report the first case using an MTX serum assay as a surrogate for PDX concentrations to avoid a potential drug-drug interaction with pralatrexate. We describe a 76-year-old man with refractory cutaneous T-cell lymphoma who began therapy with weekly PDX 15 mg/m(2) intravenous infusions on days 1, 8, and 15 of a 28-day cycle...
February 2016: Pharmacotherapy
https://www.readbyqxmd.com/read/26637771/peripheral-t-cell-lymphoma-nos-and-anaplastic-large-cell-lymphoma
#19
Anne W Beaven, Louis F Diehl
Peripheral T-cell lymphomas (PTCL), with the exception of anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL), have a very poor prognosis. Although current first line chemotherapy continues to be a CHOP-like (cyclophosphamide, doxorubicin, vincristine, prednisone) regimen there is now data suggesting that the addition of etoposide in younger patients improves outcomes. Even for those patients who do have a response to therapy, the risk of relapse remains quite high. Although autologous transplant in first remission is often used, its role as consolidation therapy in first remission remains unclear and may preferentially benefit low-risk patients...
2015: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/26627450/a-phase-ii-study-of-cyclophosphamide-etoposide-vincristine-and-prednisone-ceop-alternating-with-pralatrexate-p-as-front-line-therapy-for-patients-with-peripheral-t-cell-lymphoma-ptcl-final-results-from-the-t-cell-consortium-trial
#20
MULTICENTER STUDY
Ranjana H Advani, Stephen M Ansell, Mary J Lechowicz, Anne W Beaven, Fausto Loberiza, Kenneth R Carson, Andrew M Evens, Francine Foss, Steven Horwitz, Barbara Pro, Lauren C Pinter-Brown, Sonali M Smith, Andrei R Shustov, Kerry J Savage, Julie M Vose
Peripheral T-cell lymphomas (PTCL) have suboptimal outcomes using conventional CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy. The anti-folate pralatrexate, the first drug approved for patients with relapsed/refractory PTCL, provided a rationale to incorporate it into the front-line setting. This phase 2 study evaluated a novel front-line combination whereby cyclophosphamide, etoposide, vincristine and prednisone (CEOP) alternated with pralatrexate (CEOP-P) in PTCL. Patients achieving a complete or partial remission (CR/PR) were eligible for consolidative stem cell transplantation (SCT) after 4 cycles...
February 2016: British Journal of Haematology
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