CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Brentuximab vedotindrug
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/NCT01909934
NCT01909934Phase 4Completed
CompareCT.gov

A Phase 4, Open-label, Single-Arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma

Takeda·interventional·Posted Jul 29, 2013·Updated Sep 19, 2025

In Brief

A Phase 4 clinical trial evaluating Brentuximab vedotin for Lymphoma. Completed, enrolled 50 participants across 40 sites in 10 countries.

Detailed Summary

The purpose of this study is to assess the antitumor efficacy of single-agent brentuximab vedotin 1.8 mg/kg administered intravenously (IV) every 3 weeks, as measured by the overall objective response rate (ORR) in patients with r/r sALCL following at least 1 multiagent chemotherapy regimen (cyclophosphamide, doxorubicin hydrochloride \[hydroxydaunorubicin\], vincristine sulfate \[Oncovin\], and prednisone \[CHOP\] or equivalent multiagent chemotherapy regimens with curative intent).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesBelgium, Croatia, Czechia, Hungary, Poland, Portugal, Romania, Spain, Turkey (Türkiye), United Kingdom
CollaboratorsTakeda Development Center Americas, Inc.

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 29, 2013
Enrollment StartJan 23, 2014
Primary CompletionMay 4, 2021
Study CompletionAug 29, 2024
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 12.9 years ago

Interventions

Brentuximab vedotindrug

Brentuximab vedotin IV infusion