drugset / Trial / NCT01871727
A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma
Phase 3
Completed
112 enrolled
Eisai Inc.
Citius Pharmaceuticals, Inc. · collabDr. Reddy's Laboratories Limited · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this trial is to assess the efficacy of E7777 in participants with recurrent or persistent Cutaneous T-Cell Lymphoma (CTCL) in Stage I - III participants as assessed by objective response rate (ORR). A lead-in dose-finding part was used to determine dose level 9 microgram per kilogram (mcg/kg) E7777 that is being used to test efficacy and safety.
Timeline
- Start
- 2013-05-30
- Primary completion
- 2021-12-06
- Completion
- 2021-12-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | denileukin diftitox | Protein / enzyme biologic | 9 ug/kg | Intravenous |