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LymphomaPhase 4NCT01909934

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

A Phase 4 study testing Brentuximab vedotin in people with Lymphoma, run by Takeda at 40 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Brentuximab vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
40 sitesin 10 countries
Study dates
23 Jan 2014to 29 Aug 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

40 sites in 10 countries.

40 sites in 10 countries

Turkey (Türkiye)6 sites

  • Ankara University Medical Faculty

    Ankara, 06340

  • Pamukkale Uni. Med. Fac.

    Denizli, 20070

  • Istanbul Bilim University Medical Fac.

    Istanbul, 34200

  • Ege University Medical Faculty

    Izmir, 35040

  • Dokuz Eylul University Faculty of Medicine

    Izmir, 35340

  • Erciyes University Medical Faculty

    Kayseri, 38039

Other trials in Turkey (Türkiye)

Spain5 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • ICO lHospitalet Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

Other trials in Spain

Belgium4 sites

  • ZNA Stuivenberg

    Antwerp, 2060

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Czechia4 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Malopolskie Centrum Medyczne s.c.

    Krakow, 30-510

  • SPZOZ MSW zWarminsko-MazurskimCen.Onko.wOlsztynie

    Olsztyn, 10-228

  • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

    Warsaw, 02-781

Other trials in Poland

Portugal4 sites

  • Hospital de Braga

    Braga, 4710-243

  • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

    Lisbon, 1649-035

  • Centro Hospitalar do Porto, E.P.E. - Hospital de Santo Antonio

    Porto, 4099-001

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

Other trials in Portugal

Romania4 sites

  • Policlinica de Diagnostic Rapid SA

    Brasov, 500152

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • Spitalul Clinic Coltea

    Bucharest, 030171

  • Spitalul Clinic Judetean de Urgenta Targu Mures

    Târgu Mureş, 540042

Other trials in Romania

Croatia3 sites

  • Clinical Hospital Centre Rijeka

    Rijeka, 51000

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000

  • Clinical Hospital Dubrava

    Zagreb, 10000

Other trials in Croatia

Hungary3 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Pecsi Tudomanyegyetem

    Pécs, 7624

Other trials in Hungary

United Kingdom3 sites

  • Birmingham Heartlands Hospital

    Birmingham, West Midlands, B9 5SS

  • The Christie

    Manchester, Greater Manchester, M20 4BX

  • Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

About this study

Official title: 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).

Conditions
Lymphoma
Being tested
Brentuximab vedotin
Keywords
Lymphoma, Anaplastic Large-cell, Relapsed, Refractory, Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Anaplastic, monomethyl auristatin E, Drug Therapy, Immunotherapy, Hematologic Diseases
Medical subject headings
Lymphoma, Recurrence, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Anaplastic, Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brentuximab vedotinDrug

    Also called SGN-35, ADCETRIS

    Brentuximab vedotin IV infusion

Study groups in NCT01909934
Study groupRoleWhat they receive
Brentuximab Vedotin 1.8 mg/kgExperimentalParticipants 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.
Receives: Drug: Brentuximab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to data cut-off date: 04 May 2021 (Up to approximately 7 years)

Secondary outcomes (10)

  1. Duration of Response (DOR) Per IRF

    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.

    Measured: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)

  2. Progression-free Survival (PFS) Per IRF

    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.

    Measured: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)

  3. Complete Remission Rate (CRR) Per IRF

    CRR is defined as percentage of participants with CR. CR is defined as the disappearance of all evidence of disease.

    Measured: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)

  4. Overall Survival (OS)

    OS is defined as the time from start of study treatment to date of death due to any cause.

    Measured: Until disease progression, death, or end of study (Up to approximately 10.7 years)

  5. Percentage of Participants Receiving Hematopoietic Stem Cell Transplant (SCT) Following Treatment With Brentuximab Vedotin

    Measured: Until disease progression, death, or end of study (Up to approximately 10.7 years)

  6. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs by Severity (Grade 3 or Higher)

    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.

    Measured: From first dose up to 30 days post last dose of study drug (Up to approximately 1 year)

  7. Concentration of Serum Antibody-drug Conjugate (ADC) at the End of Infusion

    Measured: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion

  8. Concentration of Serum Total Antibody (TAb) Conjugate Plus Free Total Antibody

    Measured: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion

  9. Maximum Concentration for Unconjugated Drug- Monomethyl Auristatin E (MMAE)

    Measured: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion

  10. Percentage of Participants With Presence of Anti-Therapeutic Antibodies (ATA) and Neutralizing Antibodies (NAb) to Brentuximab Vedotin

    Measured: Up to 16 cycles (each cycle = 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2013 (estimated)
  2. Study start23 Jan 2014
  3. Primary completion4 May 2021
  4. Study completion29 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01909934
Sponsor's protocol ID
C25006
Other IDs
2012-004128-39, U1111-1154-9784, REec-2014-0649, 13/NI/0072
Status last verified
Aug 2025
First submitted
1 Jul 2013
Last updated
19 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Brentuximab vedotin in people with Lymphoma, run by Takeda at 40 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Turkey (Türkiye), Spain, Belgium, Czechia, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to data cut-off date: 04 May 2021 (Up to approximately 7 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01909934.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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