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E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma

NCT01401530 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2018-11-23

Study results available
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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.

Conditions

  • Peripheral T-Cell Lymphoma

Interventions

BIOLOGICAL

denileukin diftitox (E7777)

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.

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Tadashi Nakanishi · Eisai Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-08-31
Completion
2016-01-31

Countries

  • Japan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01401530 on ClinicalTrials.gov