Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
A Phase 4, Open-label, Single-Arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
5 other identifiers
interventional
50
10 countries
40
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 lymphoma
Started Jan 2014
Longer than P75 for phase_4 lymphoma
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 29, 2013
CompletedStudy Start
First participant enrolled
January 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2021
CompletedResults Posted
Study results publicly available
May 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2024
CompletedSeptember 19, 2025
August 1, 2025
7.3 years
July 1, 2013
May 4, 2022
August 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a complete remission (CR) or partial remission (PR) by Independent Review Facility (IRF) response assessment according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
Up to data cut-off date: 04 May 2021 (Up to approximately 7 years)
Secondary Outcomes (10)
Duration of Response (DOR) Per IRF
Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
Progression-free Survival (PFS) Per IRF
Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
Complete Remission Rate (CRR) Per IRF
Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
Overall Survival (OS)
Until disease progression, death, or end of study (Up to approximately 10.7 years)
Percentage of Participants Receiving Hematopoietic Stem Cell Transplant (SCT) Following Treatment With Brentuximab Vedotin
Until disease progression, death, or end of study (Up to approximately 10.7 years)
- +5 more secondary outcomes
Study Arms (1)
Brentuximab Vedotin 1.8 mg/kg
EXPERIMENTALParticipants received brentuximab vedotin 1.8 mg/kg as a 30 minute intravenous (IV) infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
Interventions
Brentuximab vedotin IV infusion
Eligibility Criteria
You may qualify if:
- Male or female participants age 18 years or older, with relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy
- Bidimensional measurable disease
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence
- Male participants who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence
- Clinical laboratory values as specified in the study protocol
You may not qualify if:
- Previous treatment with brentuximab vedotin.
- Previously received an allogeneic transplant.
- Participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma \[ALCL\] (participants whose ALCL has transformed to sALCL are eligible).
- Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
- Female participants who are lactating and breastfeeding or pregnant
- Known human immunodeficiency virus (HIV) positive
- Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
- Takeda Development Center Americas, Inc.collaborator
Study Sites (40)
ZNA Stuivenberg
Antwerp, 2060, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
Clinical Hospital Centre Rijeka
Rijeka, 51000, Croatia
Clinical Hospital Centre Zagreb
Zagreb, 10000, Croatia
Clinical Hospital Dubrava
Zagreb, 10000, Croatia
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Semmelweis Egyetem
Budapest, 1083, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Pecsi Tudomanyegyetem
Pécs, 7624, Hungary
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Malopolskie Centrum Medyczne s.c.
Krakow, 30-510, Poland
SPZOZ MSW zWarminsko-MazurskimCen.Onko.wOlsztynie
Olsztyn, 10-228, Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warsaw, 02-781, Poland
Hospital de Braga
Braga, 4710-243, Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Centro Hospitalar do Porto, E.P.E. - Hospital de Santo Antonio
Porto, 4099-001, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
Policlinica de Diagnostic Rapid SA
Brasov, 500152, Romania
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Spitalul Clinic Coltea
Bucharest, 030171, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureş, 540042, Romania
ICO lHospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Ankara University Medical Faculty
Ankara, 06340, Turkey (Türkiye)
Pamukkale Uni. Med. Fac.
Denizli, 20070, Turkey (Türkiye)
Istanbul Bilim University Medical Fac.
Istanbul, 34200, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, 35040, Turkey (Türkiye)
Dokuz Eylul University Faculty of Medicine
Izmir, 35340, Turkey (Türkiye)
Erciyes University Medical Faculty
Kayseri, 38039, Turkey (Türkiye)
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ, United Kingdom
The Christie
Manchester, Greater Manchester, M20 4BX, United Kingdom
Birmingham Heartlands Hospital
Birmingham, West Midlands, B9 5SS, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2013
First Posted
July 29, 2013
Study Start
January 23, 2014
Primary Completion
May 4, 2021
Study Completion
August 29, 2024
Last Updated
September 19, 2025
Results First Posted
May 26, 2022
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.