CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
KW-0761drug
Likely dose
KW-0761 at 4 escalating dose levels via IV administrationAI-extracted
Key inclusion· 8
  • ✓Histologically confirmed CCR4-positive ATL (seropositive for HTLV-I, acute/lymphoma/chronic phase with high-risk factors) or PTCL (including mycosis fungoides and Sézary syndrome)
  • ✓Relapsed to latest standard chemotherapy
  • ✓Received at least one prior chemotherapy
  • ✓Measurable disease present
Key exclusion· 12
  • ✕Active infection or co-existing medical condition compromising safety
  • ✕Active tuberculosis
  • ✕Prior stem cell transplantation
  • ✕Myocardial infarction within 12 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00355472
NCT00355472Phase 1Completed
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Phase I Dose Escalation Study of KW-0761 in Patients With Relapsed Adult T-Cell Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL)

Kyowa Kirin Co., Ltd.·interventional·Posted Jul 24, 2006·Updated Oct 18, 2012

In Brief

A Phase 1 clinical trial evaluating KW-0761 for Adult T-Cell Leukemia and Lymphoma (ATL) and Adult Peripheral T-Cell Lymphoma (PTCL). Completed, enrolled 16 participants across 1 site.

Detailed Summary

This is a Phase I label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult T-Cell Leukemia and Lymphoma (ATL), Adult Peripheral T-Cell Lymphoma (PTCL)
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 24, 2006
Enrollment StartFeb 1, 2007
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.9 years ago

Interventions

KW-0761drug

IV administration at 4 escalating dose levels.