Trial of Intravenous Fenretinide Emulsion for Patients With Relapsed/Refractory Peripheral T-cell Lymphomas
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Peripheral T Cell Lymphoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 e...
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.
Tracking Information
- NCT #
- NCT02495415
- Collaborators
- Not Provided
- Investigators
- Study Director: Kerry M. Barnhart, Ph.D. CerRx, Inc.