At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 13 enrolled
Drug / intervention
denileukin diftitox (E7777)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase1/1b Clinical Trial of E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
In Brief
A Phase 1 clinical trial evaluating denileukin diftitox (E7777) for Peripheral T-Cell Lymphoma. Completed, enrolled 13 participants across 4 sites.
Detailed Summary
The purpose of this Phase 1 study is to determine the maximum tolerated dose (MTD) through observation of dose limiting toxicity (DLT), which is in advance defined, in patients with peripheral or cutaneous T-cell lymphoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral T-Cell Lymphoma
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2011
First PostedJul 2011
Primary CompletionAug 2015
Study CompletionJan 2016
TodayJul 2026
First PostedJul 25, 2011
Enrollment StartJul 1, 2011
Primary CompletionAug 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 14.9 years ago
Interventions
denileukin diftitox (E7777)biological
E7777 will be administered by intravenous (IV) infusion for 5 days from Day 1 through 5 of each cycle (21 days/cycle) with 8 cycles in maximum for E7777 alone therapy. E7777 dose will be escalated from 6 micro-g/kg/day to 12, 15 and then to 18 in a stepwise fashion.