Abstract

This is a multicenter phase III blinded, randomized study, to evaluate the efficacy and safety of two dose levels of DAB389IL-2 in CTCL patients. The objectives of the study are: 1) To demonstrate efficacy of two dose levels of DAB389IL-2 in CTCL patients assessed by the frequency and duration of complete, clinical complete and partial responses, 2) To assess changes in CTCL symptoms and functional status in association with DAB389IL-2 administration, 3) To further evaluate the safety and tolerability of DAB389IL-2 for these doses and schedule, 4) to further characterize the pharmacokinetics of this agent in CTCL patients. An intent-to-treat analysis will be performed, therefore, any patient receiving one dose will be considered evaluable. To date 2 subjects have been enrolled at this site.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000080-34
Application #
5219152
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
34
Fiscal Year
1996
Total Cost
Indirect Cost

  Publications

Randis, Tara M; Rice, Madeline Murguia; Myatt, Leslie et al. (2018) Incidence of early-onset sepsis in infants born to women with clinical chorioamnionitis. J Perinat Med 46:926-933
Clark, Erin A S; Weiner, Steven J; Rouse, Dwight J et al. (2018) Genetic Variation, Magnesium Sulfate Exposure, and Adverse Neurodevelopmental Outcomes Following Preterm Birth. Am J Perinatol 35:1012-1022
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Saade, G R; Thom, E A; Grobman, W A et al. (2018) Cervical funneling or intra-amniotic debris and preterm birth in nulliparous women with midtrimester cervical length less than 30 mm. Ultrasound Obstet Gynecol 52:757-762
Inker, Lesley A; Grams, Morgan E; Levey, Andrew S et al. (2018) Relationship of Estimated GFR and Albuminuria to Concurrent Laboratory Abnormalities: An Individual Participant Data Meta-analysis in a Global Consortium. Am J Kidney Dis :
Juraschek, Stephen P; Miller 3rd, Edgar R; Appel, Lawrence J (2018) Orthostatic Hypotension and Symptoms in the AASK Trial. Am J Hypertens 31:665-671
Di Fiore, Juliann M; Martin, Richard J; Li, Hong et al. (2017) Patterns of Oxygenation, Mortality, and Growth Status in the Surfactant Positive Pressure and Oxygen Trial Cohort. J Pediatr 186:49-56.e1
Osman, Ahmed Fageer; Thomas, Biju; Singh, Nakul et al. (2017) Impact of Infant-Polysomnography Studies on Discharge Management and Outcomes: A 5 Year Experience from a Tertiary Care Unit. J Neonatal Biol 6:
Tita, Alan T N; Lai, Yinglei; Landon, Mark B et al. (2017) Predictive Characteristics of Elevated 1-Hour Glucose Challenge Test Results for Gestational Diabetes. Am J Perinatol 34:1464-1469
Grams, Morgan E; Yang, Wei; Rebholz, Casey M et al. (2017) Risks of Adverse Events in Advanced CKD: The Chronic Renal Insufficiency Cohort (CRIC) Study. Am J Kidney Dis 70:337-346

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