Trial of Intravenous Fenretinide Emulsion for Patients With Relapsed/Refractory Peripheral T-cell Lymphomas

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Unknown Primary	NCT ID:	NCT02495415
Trial Phases:	Phase II	Protocol IDs:	FEN T-14 (primary) NCI-2015-01195
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	CerRx, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT02495415

Summary

This study addresses the hypothesis that intermittent treatment with fenretinide
intravenous emulsion will induce objective responses in patients with relapsed or
refractory Peripheral T-cell Lymphoma (PTCL) who have failed at least one prior systemic
therapy and will result in acceptable toxicities.

Objectives

This is an open-label, multicenter, single arm efficacy and safety study in patients with
relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior
system therapy.

Approximately 140 patients will be enrolled. Patients will be treated with fenretinide
(4-HPR) intravenous emulsion administered as a continuous intravenous infusion for 5
days, once every 3 weeks until there is disease progression or unmanageable
treatment-related toxicities.

The primary study endpoint is objective response rate (ORR). Responses will be
categorized using criteria established by the International Harmonization Project on
Lymphoma. Safety will be evaluated during the study and for 30 days after the last
administration of study drug. Adverse events and laboratory studies will be graded
according to NCI-CTCAE v. 4.03.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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