A Phase 3 Trial of E7777 in Combination With CHOP Compared With CHOP Alone for the First-Line Treatment of Peripheral T-cell Lymphoma

Phase 3

Withdrawn

• Conditions: Peripheral T-Cell Lymphoma
• Interventions: Drug: E7777

• Registration Number: NCT01355783
• Lead Sponsor: Eisai Inc.

Brief Summary

The purpose of this study is to evaluate whether treatment of E7777 in combination with CHOP has superior efficacy compared with CHOP alone in improving complete response rate (CRR) in first line treatment of subjects with Peripheral T-cell Lymphoma (PTCL).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-17
• Study First Posted: 2011-05-18
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-18
• Primary Completion: 2014-10
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHOP alone	E7777	-
E7777 + CHOP Chemotherapy	E7777	-

Primary Outcome Measures

Name	Time	Method
To evaluate whether treatment of E7777 in combination with CHOP chemotherapy has superior efficacy compared with CHOP alone in improving progression-free survival (PFS) in first line treatment of subjects with peripheral T-cell lymphoma	pre-randomization 4 weeks until disease progression	* Pretreatment or pre-randomization (screening and baseline): 4 weeks.; * Treatment: 18 weeks.; * Follow up: 2 to 3 years after the end of study treatment. Treatment will stop upon disease progression, unacceptable toxicity, or death, whichever occurs first. The Investigator or subject may also stop study treatment at any time for safety or personal reasons; however subject should remain on study, if possible, for follow-up.

Secondary Outcome Measures

Name	Time	Method
To evaluate whether E7777 in combination with CHOP treatment has superior efficacy compared with CHOP treatment alone as assessed by overall survival (OS) and by transplant rate.· To compare safety of E7777 in combination with CHOP	pre-randomization 4 weeks until disease progression	* Pretreatment or pre-randomization (screening and baseline): 4 weeks.; * Treatment: 18 weeks.; * Follow up: 2 to 3 years after the end of study treatment. Treatment will stop upon disease progression, unacceptable toxicity, or death, whichever occurs first. The Investigator or subject may also stop study treatment at any time for safety or personal reasons; however subject should remain on study, if possible, for follow-up.