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New combo shows promise against Tough-to-Treat lymphoma

NCT ID NCT04569032

Disease control Sponsor: Seagen, a wholly owned subsidiary of Pfizer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study tested a combination of the targeted drug brentuximab vedotin (ADCETRIS) plus standard CHP chemotherapy in 82 people with newly diagnosed peripheral T-cell lymphoma (PTCL) that has low CD30 levels. The goal was to see how many patients' tumors shrank or disappeared. Results showed that many patients responded to the treatment, but side effects were common. This early-phase trial suggests the combo may be an option for this hard-to-treat cancer, but more research is needed.

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 (ADCETRIS) plus CHP chemotherapy (cyclophosphamide, doxorubicin, prednisone)
What this could lead to
If successful, this combination could become a new frontline treatment option for certain types of PTCL that have low CD30 expression, potentially improving response rates.
What could go wrong
This is a small, early-phase (Phase 2) study with no control group, so results are preliminary. Side effects from chemotherapy and brentuximab vedotin can be serious, and long-term benefits are not yet proven.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

82 people

The number who actually took part.

Started

Nov 2020

Finished

Jan 2026

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 * Newly diagnosed PTCL, excluding systemic anaplastic large cell lymphoma (sALCL), per the Revised European-American Lymphoma World Health Organization (WHO) 2016 classification * The following non-sALCL PTCL subtypes are eligible: * PTCL - not otherwise specified (PTCL-NOS) * Angioimmunoblastic T-cell lymphoma (AITL) * Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukemia virus 1) * Enteropathy-associated T-cell lymphoma (EATL) * Hepatosplenic T-cell lymphoma * Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL) * Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract * Follicular T-cell lymphoma * Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype * CD30 expression \<10% by local assessment in tumor containing lymph node or other extranodal soft tissue biopsy * Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT, as assessed by the site radiologist * An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Exclusion Criteria * Current diagnosis of any of the following: * sALCL * Primary cutaneous T-cell lymphoproliferative disorders and lymphomas * Mycosis fungoides (MF), including transformed MF * History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), such as carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer. * History of progressive multifocal leukoencephalopathy (PML). * Cerebral/meningeal disease related to the underlying malignancy. * Prior treatment with brentuximab vedotin or doxorubicin. * Baseline peripheral neuropathy Grade 2 or higher (per the NCI CTCAE, Version 4.03) or subjects with the demyelinating form of Charcot-Marie-Tooth syndrome. * Left ventricular ejection fraction less than 45% or symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), or myocardial infarction within the past 6 months, or previous treatment with complete cumulative dose of \>300 mg/m2 of doxorubicin. * Any uncontrolled Grade 3 or higher (per the National Cancer Institute's Common Terminology Criteria for Adverse Events, NCI CTCAE Version 4.03) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug. Routine antimicrobial prophylaxis is permitted.

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Conditions

The condition(s) this trial relates to.

adult T-cell leukemia/lymphoma angioimmunoblastic T-cell lymphoma enteropathy-associated T-cell lymphoma hepatosplenic T-cell lymphoma mature T-cell and NK-cell non-Hodgkin lymphoma monomorphic epitheliotropic intestinal T-cell lymphoma Nodal T-follicular helper cell lymphoma, follicular type peripheral T-cell lymphoma, not otherwise specified

As listed by the trial registrant

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

Peripheral T-cell lymphoma

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Integrata Verona Policlinico G.B. Rossi

    Verona, 37134, Italy

  • Azienda Ospedaliero Universitaria di Bologna - IRCCS

    Bologna, Emilia-Romagna, 40138, Italy

  • CHU Grenoble Alpes

    Tronche, Auvergne-Rhône-Alpes, 38700, France

  • Cetir Centre Medic

    Barcelona, 08029, Spain

  • Cleveland Clinic taussig Cancer Center Investigational Pharmacy

    Cleveland, Ohio, 44106, United States

  • Cleveland Clinic, The

    Cleveland, Ohio, 44195, United States

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122, Italy

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Lombardy, 27100, Italy

  • Fondazione del Piemonte per l'Oncologia (FPO) - IRCCS Candiolo - Oncologia Medica

    Candiolo, Turin, 10060, Italy

  • Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Hopital Emile Muller

    Mulhouse, 68070, France

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Duran I Reynals - Institut Catala d'Oncologia

    Barcelona, 08908, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario De La Paz

    Madrid, Other, 28046, Spain

  • Höpital Haut Levéque - CHU Bordeaux Service d'hématologie clinique et thérapie cellulaire

    Pessac, 33604, France

  • IEC Trials, Hospital La Milagrosa.

    Madrid, Other, 28010, Spain

  • IRCCS Ospedale Policlinico San Martino

    Genova, Other, 16132, Italy

  • MACMILLIAN Cancer Centre

    London, WC1E 6AG, United Kingdom

  • Massey Cancer Center Clinical & Translational Research Lab

    Richmond, Virginia, 23298, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center David H. Koch Center for Cancer Care

    New York, New York, 10021, United States

  • Oxford University Hospitals

    Headington, Oxford, OX3 7LE, United Kingdom

  • Rocky Mountain Cancer centers, LLP

    Aurora, Colorado, 80012, United States

  • Rocky Mountain Cancer centers, LLP

    Boulder, Colorado, 80303, United States

  • Rocky Mountain Cancer centers, LLP

    Colorado Springs, Colorado, 80907, United States

  • Rocky Mountain Cancer centers, LLP

    Denver, Colorado, 80218, United States

  • Rocky Mountain Cancer centers, LLP

    Denver, Colorado, 80220, United States

  • Rocky Mountain Cancer centers, LLP

    Lakewood, Colorado, 80228, United States

  • Rocky Mountain Cancer centers, LLP

    Littleton, Colorado, 80120, United States

  • Rocky Mountain Cancer centers, LLP

    Lone Tree, Colorado, 80124, United States

  • Rocky Mountain Cancer centers, LLP

    Longmont, Colorado, 80504, United States

  • Rocky Mountain Cancer centers, LLP

    Pueblo, Colorado, 81003, United States

  • Rocky Mountain Cancer centers, LLP

    Thornton, Colorado, 80260, United States

  • Stanford Cancer Center

    Stanford, California, 94305, United States

  • Stanford Hospital and Clinics, Investigational Drug Services

    Stanford, California, 94305, United States

  • Texas Oncology - Central South (Balcones Dr)

    Austin, Texas, 78731, United States

  • Texas Oncology - Central South (James Casey)

    Austin, Texas, 78745, United States

  • Texas Oncology - Central/South Texas

    Austin, Texas, 78705, United States

  • Texas Oncology-Northeast Texas

    Longview, Texas, 75601, United States

  • Texas Oncology-Northeast Texas

    Palestine, Texas, 75801, United States

  • Texas Oncology-Northeast Texas

    Paris, Texas, 75460, United States

  • Texas Oncology-Northeast Texas

    Tyler, Texas, 75702, United States

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Tulane Cancer Center

    New Orleans, Louisiana, 70112, United States

  • Tulane Medical Center

    New Orleans, Louisiana, 70112, United States

  • UCLH Hospitals

    London, NWI 2BG, United Kingdom

  • US Oncology Investigational Products Center (IPC)

    Irving, Texas, 75063, United States

  • US Oncology Investigational Products Center(IPC)

    Irving, Texas, 75063, United States

  • US Oncology lnvestigational Products Center (IPC)

    Irving, Texas, 75063, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • VCU Massey Cancer Center-Radiation Oncology

    Richmond, Virginia, 23219, United States

  • VCU Medical Center -InPatient

    Richmond, Virginia, 23219, United States

  • VCU Medical Center Critical Care Hospital

    Richmond, Virginia, 23219, United States

  • VCU at Stony Point

    Richmond, Virginia, 23235, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23219, United States

  • Virginia Oncology Associates

    Chesapeake, Virginia, 23320, United States

  • Virginia Oncology Associates

    Hampton, Virginia, 23666, United States

  • Virginia Oncology Associates

    Newport News, Virginia, 23606, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

  • Virginia Oncology Associates

    Virginia Beach, Virginia, 23456, United States

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