NCT02495415

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

Phase II Trial of Intravenous Fenretinide (N-(4-hydroxyphenyl) Retinamide, 4-HPR) Emulsion for Patients With Relapsed/Refractory Peripheral T-cell Lymphomas (PTCL)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: CerRx, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Fenretinide	Fenretinide intravenous emulsion administered as a continuous intravenous infusion for 5 days, once every 3 weeks in relapsed/refractory PTCL patients.

Timeline

• Start date: 2016-12-01
• Primary completion: 2021-07-01
• Completion: 2021-12-01
• First posted: 2015-07-13
• Last updated: 2019-07-23

Locations

11 sites across 1 country: United States