CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 131 enrolled
Drug / intervention
Brentuximab Vedotin +2 moredrug
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/NCT01578499
NCT01578499Phase 3Completed
CompareCT.gov

A Randomized, Open-Label, Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

Millennium Pharmaceuticals, Inc.·interventional·Posted Apr 17, 2012·Updated Jan 5, 2021

In Brief

A Phase 3 clinical trial evaluating Brentuximab Vedotin, Methotrexate, and 1 other intervention for Primary Cutaneous Anaplastic Large Cell Lymphoma and 2 related conditions. Completed, enrolled 131 participants across 41 sites in 12 countries.

Detailed Summary

The purpose of this study is to determine objective response rate (ORR), lasting at least 4 months (ORR4), with brentuximab vedotin in participants with cluster of differentiation antigen 30 positive (CD30+) cutaneous T-cell lymphoma \[mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) \]compared to that achieved with therapy in the control arm.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Cutaneous Anaplastic Large Cell Lymphoma, Mycosis Fungoides, Cutaneous T-Cell Lymphoma
CountriesAustralia, Austria, Belgium, Brazil, France, Germany, Italy, Poland, Spain, Switzerland, United Kingdom, United States
CollaboratorsSeagen Inc.

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 17, 2012
Enrollment StartJun 11, 2012
Primary CompletionMay 31, 2016
Study CompletionJul 6, 2018
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 14.2 years ago

Interventions

Brentuximab Vedotindrug

Brentuximab vedotin intravenous injection.

Methotrexatedrug

Methotrexate tablets.

Bexarotenedrug

Bexarotene tablets.