A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01561833
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : February 19, 2015
Information provided by (Responsible Party):
Yale University

March 13, 2012
March 23, 2012
February 19, 2015
October 2009
May 2013   (Final data collection date for primary outcome measure)
Biological Effects of Sorafenib on ERK phosphorylation in patients with T-cell lymphoma [ Time Frame: 29 days to the baseline value ]
A paired t-test will be used to compare the actual values if these appear to be normally distributed. Otherwise a nonparametric sign test will be used, treating the difference of every patient's baseline to their day 29 value as a toss of a fair coin.
Same as current
Complete list of historical versions of study NCT01561833 on Archive Site
Objective response rate of patients following initial treatment with sorafenib and progression free survival [ Time Frame: 8 weeks following initial treatment ]
Patients with stable disease (SD), complete or partial response (CRIPR) lasting at least 8 weeks would be considered to have a meaningful clinical effect from sorafenib.
Same as current
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A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients
A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients
This study will be a pilot study of sorafenib 400mg PO twice daily in refractory T-cell lymphomas including peripheral T-cell lymphoma (PTCL), angioimmunoblastic lymphadenopathy (AILD), cutaneous T cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL) and other transformed T-cell lymphomas with the primary objective of studying the biological effects of the multikinase inhibitor, sorafenib.

Primary objectives:

• To study the biological effects of sorafenib 400mg BID on the mitogen-activated protein kinase (MAPK) pathway, specifically the inhibition of extracellular signal-regulated kinases (ERK) phosphorylation, and to correlate with clinical activity in patients with T-cell lymphoma.

Secondary objectives:

  • To observe the clinical activity of sorafenib 400mg BID by determining response rate, and progression free survival in patients with T-cell lymphoma. Duration of response and duration of stable disease will also be measured.
  • To determine the tolerability of sorafenib in patients with T-cell lymphoma.

Exploratory objectives:

  • To observe the effects of sorafenib on T-cell subsets (CD4/CD8 ratio, and Tregs), and the effects of sorafenib on the monocytoid population.
  • To observe the effects of sorafenib on the serum cytokine profile.
  • To observe the effects of sorafenib on the T-cell receptor pathway, i.e. Lck, ZAP-70, and Syk.
  • To observe changes in lymph node or skin morphology including tumor cell infiltrate, vasculature, and the tumor microenvironment in patients treated with sorafenib by performing serial biopsies of lymph nodes or skin.
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
T Cell Lymphoma
Drug: Sorafenib
Intrapatient dose reduction to 400 mg once daily and then 400 mg every other day will be allowed depending on the type and severity of toxicity encountered provided that criteria for patient withdrawal from study treatment have not been met.
Experimental: Sorafenib
Sorafenib, 400 mg PO twice daily
Intervention: Drug: Sorafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2013
May 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed T-cell lymphoma including PTCL, AITL, CTCL, ALCL (Alk+, and Alk-), and other transformed T-cell lymphomas
  • Age > 18 years old
  • Measureable disease, as defined by the Cheson criteria
  • ECOG Performance Status of 0 or 1
  • Life expectancy > 12 weeks
  • Adequate bone marrow, liver and renal function
  • Patients with hemoglobin < 8.5g/dL, or ANC 500-1000/mm3, or platelets 50,000-75,000/mm3 (Grade 3), whose cytopenias are due to bone marrow involvement by T-cell lymphoma will also be eligible

Exclusion Criteria:

  • Prior treatment with sorafenib, or other agents with similar activity, i.e. bevacizumab, imatinib, sunitinib.
  • Prior treatment with allogeneic stem cell transplant
  • Cardiac disease: Congestive heart failure > class II NYHA.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Yale University
Yale University
Not Provided
Principal Investigator: Francine Foss, MD Yale University
Yale University
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP