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Targeted drug shows promise for rare blood cancer in completed trial

NCT ID NCT01909934

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed Phase 4 trial tested the drug brentuximab vedotin in 50 adults with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL), a rare blood cancer. Participants had already received at least one round of chemotherapy. The study measured how many patients had their tumors shrink or disappear. Results help understand the drug's effectiveness in this difficult-to-treat group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brentuximab vedotin (a targeted antibody-drug conjugate)
What this could lead to
If successful, this could provide a treatment option for patients with relapsed or refractory systemic anaplastic large cell lymphoma who have limited alternatives.
What could go wrong
This is a single-arm, open-label study with only 50 participants, so results may not be generalizable. The drug may cause side effects, and not all patients may respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

50 people

The number who actually took part.

Started

Jan 2014

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

anaplastic large cell lymphoma hematologic disorder lymphoma non-Hodgkin lymphoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoma

Contacts and locations

Locations

  • Ankara University Medical Faculty

    Ankara, 06340, Turkey (Türkiye)

  • Birmingham Heartlands Hospital

    Birmingham, West Midlands, B9 5SS, United Kingdom

  • 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

  • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

    Warsaw, 02-781, Poland

  • Clinical Hospital Centre Rijeka

    Rijeka, 51000, Croatia

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000, Croatia

  • Clinical Hospital Dubrava

    Zagreb, 10000, Croatia

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Dokuz Eylul University Faculty of Medicine

    Izmir, 35340, Turkey (Türkiye)

  • Ege University Medical Faculty

    Izmir, 35040, Turkey (Türkiye)

  • Erciyes University Medical Faculty

    Kayseri, 38039, Turkey (Türkiye)

  • Fakultni nemocnice Brno

    Brno, 625 00, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34, Czechia

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • ICO lHospitalet Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072, Portugal

  • Istanbul Bilim University Medical Fac.

    Istanbul, 34200, Turkey (Türkiye)

  • Malopolskie Centrum Medyczne s.c.

    Krakow, 30-510, Poland

  • Pamukkale Uni. Med. Fac.

    Denizli, 20070, Turkey (Türkiye)

  • Pecsi Tudomanyegyetem

    Pécs, 7624, Hungary

  • Policlinica de Diagnostic Rapid SA

    Brasov, 500152, Romania

  • Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ, United Kingdom

  • SPZOZ MSW zWarminsko-MazurskimCen.Onko.wOlsztynie

    Olsztyn, 10-228, Poland

  • Semmelweis Egyetem

    Budapest, 1083, Hungary

  • Spitalul Clinic Colentina

    Bucharest, 020125, Romania

  • Spitalul Clinic Coltea

    Bucharest, 030171, Romania

  • Spitalul Clinic Judetean de Urgenta Targu Mures

    Târgu Mureş, 540042, Romania

  • The Christie

    Manchester, Greater Manchester, M20 4BX, United Kingdom

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952, Poland

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08, Czechia

  • ZNA Stuivenberg

    Antwerp, 2060, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.