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

Completed · Phase 1

Conditions studied: T Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT01561833

Run by

Yale University

People needed

12

Starts

2009-10-01

Expected to finish

2013-06-01

Last updated by the study team

2020-08-13

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Yale Cancer Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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