Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma

August 29, 2025 updated by: Takeda

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2060
        • ZNA Stuivenberg
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-luc
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Croatia
      • Rijeka, Croatia, 51000
        • Clinical Hospital Centre Rijeka
      • Zagreb, Croatia, 10000
        • Clinical Hospital Centre Zagreb
      • Zagreb, Croatia, 10000
        • Clinical Hospital Dubrava
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultni nemocnice Brno
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc
      • Prague, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze
      • Prague, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Pécs, Hungary, 7624
        • Pecsi Tudomanyegyetem
  • Poland
      • Gdansk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, Poland, 30-510
        • Malopolskie Centrum Medyczne s.c.
      • Olsztyn, Poland, 10-228
        • SPZOZ MSW zWarminsko-MazurskimCen.Onko.wOlsztynie
      • Warsaw, Poland, 02-781
        • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Lisbon, Portugal, 1649-035
        • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
      • Porto, Portugal, 4200-072
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
      • Porto, Portugal, 4099-001
        • Centro Hospitalar Do Porto, E.P.E. - Hospital de Santo António
  • Romania
      • Brasov, Romania, 500152
        • Policlinica de Diagnostic Rapid SA
      • Bucharest, Romania, 030171
        • Spitalul Clinic Coltea
      • Bucharest, Romania, 020125
        • Spitalul Clinic Colentina
      • Târgu Mureş, Romania, 540042
        • Spitalul Clinic Judetean de Urgenta Targu Mures
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Ico Lhospitalet Hospital Duran I Reynals
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06340
        • Ankara University Medical Faculty
      • Denizli, Turkey (Türkiye), 20070
        • Pamukkale Uni. Med. Fac.
      • Istanbul, Turkey (Türkiye), 34200
        • Istanbul Bilim University Medical Fac.
      • Izmir, Turkey (Türkiye), 35040
        • Ege University Medical Faculty
      • Izmir, Turkey (Türkiye), 35340
        • Dokuz Eylul University Faculty of Medicine
      • Kayseri, Turkey (Türkiye), 38039
        • Erciyes University Medical Faculty
  • United Kingdom
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • The Christie
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Brentuximab Vedotin 1.8 mg/kg
Participants 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.
Drug: Brentuximab vedotin
Brentuximab vedotin IV infusion
Other Names:
  • SGN-35
  • ADCETRIS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to data cut-off date: 04 May 2021 (Up to approximately 7 years)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concentration of Serum Antibody-drug Conjugate (ADC) at the End of Infusion
Time Frame: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion
Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion
Concentration of Serum Total Antibody (TAb) Conjugate Plus Free Total Antibody
Time Frame: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion
Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion
Maximum Concentration for Unconjugated Drug- Monomethyl Auristatin E (MMAE)
Time Frame: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion
Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion
Duration of Response (DOR) Per IRF
Time Frame: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
DOR was defined as the time between initial response and documented tumor progression in the subset of participants who achieved an objective response, either CR or PR. DOR per IRF was based upon the radiological assessment of measured lesions from an independent review facility. DOR was censored on the date of the last disease assessment documenting absence of progressive disease (PD) for participants who were lost to follow-up, withdrew consent, started a new anticancer therapy other than stem cell transplant (SCT), or discontinued treatment due to undocumented PD after the last adequate disease assessment.
Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
Progression-free Survival (PFS) Per IRF
Time Frame: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
PFS is defined as the time from start of study treatment to first documentation of objective tumor progression or to death due to any cause, whichever comes first. PFS per IRF is based upon the radiological assessment from an independent review facility.
Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
Complete Remission Rate (CRR) Per IRF
Time Frame: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
CRR is defined as percentage of participants with CR. CR is defined as the disappearance of all evidence of disease.
Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
Overall Survival (OS)
Time Frame: Until disease progression, death, or end of study (Up to approximately 10.7 years)
OS is defined as the time from start of study treatment to date of death due to any cause.
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
Time Frame: Until disease progression, death, or end of study (Up to approximately 10.7 years)
Until disease progression, death, or end of study (Up to approximately 10.7 years)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs by Severity (Grade 3 or Higher)
Time Frame: From first dose up to 30 days post last dose of study drug (Up to approximately 1 year)
An adverse event (AE): any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to medicinal product. TEAE was defined as any AE that started after the first administration of study drug in this continuation study. Serious TEAEs: defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is a medically important event.
From first dose up to 30 days post last dose of study drug (Up to approximately 1 year)
Percentage of Participants With Presence of Anti-Therapeutic Antibodies (ATA) and Neutralizing Antibodies (NAb) to Brentuximab Vedotin
Time Frame: Up to 16 cycles (each cycle = 21 days)
Up to 16 cycles (each cycle = 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Takeda Development Center Americas, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2013

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C25006
  • 2012-004128-39 (EudraCT Number)
  • U1111-1154-9784 (Registry Identifier: WHO)
  • REec-2014-0649 (Registry Identifier: REec)
  • 13/NI/0072 (Registry Identifier: NRES)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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