CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Brentuximab vedotindrug
Likely dose
Brentuximab vedotin 1.8 mg/kgfrom 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/NCT01396070
NCT01396070Phase 2Completed
CompareCT.gov

Exploratory Pilot Study of Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level

Youn Kim·interventional·Posted Jul 18, 2011·Updated Apr 5, 2017

In Brief

A Phase 2 clinical trial evaluating Brentuximab vedotin for Non-Hodgkin Lymphoma (NHL) and 4 related conditions. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The purpose of this study is to learn the effects of brentuximab vedotin (SGN-35), an investigational medication, on patients with cutaneous T cell lymphoma (CTCL), specifically mycosis fungoides (MF) and Sezary syndrome (SS). Despite a wide range of therapeutic options, the treatments are associated with short response duration, thus this condition is largely incurable. This investigational drug may offer less toxicity than standard treatments and have better tumor specific targeting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin Lymphoma (NHL), Cutaneous Lymphoma, Cutaneous T-cell Lymphoma (CTCL), Mycosis Fungoides, Sezary Syndrome
CountriesUnited States
CollaboratorsSeagen Inc.

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 18, 2011
Enrollment StartMay 1, 2011
Primary CompletionApr 1, 2015
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 15.0 years ago

Interventions

Brentuximab vedotindrug

1.8 mg/kg by IV every 3 weeks for a maximum of 16 doses (8 cycles). Brentuximab vedotin is an antibody conjugate, consisting of the chimeric IgG1 anti-CD30 antibody cAC10; the microtubule disrupting agent monomethyl auristatin E (MMAE); a protease-cleavable linker that covalently attaches MMAE to cAC10.