Phase 1 N=12 Treatment

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

T Cell Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT01561833 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Overall Response Rate — 5 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Sorafenib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Response Rate	5	—

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.

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.

View full record on ClinicalTrials.gov →

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.