CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1 enrolled
Drug / intervention
KW-0761biological
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.

Search/NCT01226472
NCT01226472Phase 2Completed
CompareCT.gov

Open-Label Extension Study of Anti-CCR4 Monoclonal Antibody KW-0761 as Monotherapy in Subjects Who Relapsed After Complete Response on Study KW-0761-001

Kyowa Kirin Co., Ltd.·interventional·Posted Oct 22, 2010·Updated Apr 25, 2024

In Brief

A Phase 2 clinical trial evaluating KW-0761 for Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma. Completed, enrolled 1 participant across 1 site.

Detailed Summary

This study will enroll subjects with either Peripheral T-Cell Lymphoma (PTCL) or Cutaneous T-Cell Lymphoma(CTCL),including mycosis fungoides (MF) and Sezary Syndrome (SS), who have relapsed after achieving a complete response in study, KW-0761-001.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma
CountriesUnited States
CollaboratorsKyowa Hakko Kirin Pharma, Inc.

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 22, 2010
Enrollment StartAug 1, 2010
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.7 years ago

Interventions

KW-0761biological

In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.