Phase 1
Completed N=12
A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients
Source: ClinicalTrials.gov NCT01561833 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Overall Response Rate — 5 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
5 | — |
Eligibility Criteria
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 class II NYHA.
Data sourced from ClinicalTrials.gov (NCT01561833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.