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AzTrials

Hodgkin LymphomaPhase 2NCT03646123

Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma

A Phase 2 study testing brentuximab vedotin, doxorubicin and vinblastine in people with Hodgkin Lymphoma, run by Seagen Inc. at 76 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This trial will study two treatment combinations for classical Hodgkin lymphoma (cHL). This trial will find out if these two treatment combinations work to treat cHL. It will also find out what side effects occur. A side effect is anything the drug does besides treating cancer. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
brentuximab vedotin, doxorubicin and vinblastine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
255 participants
Where
76 sitesin 6 countries
Study dates
28 Jan 2019to 23 Aug 2024
Phase
Phase 2
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Treatment-naïve, classic Hodgkin lymphoma (cHL) participants
  • Participants enrolling in Part A of the study must have Ann Arbor Stage III or IV disease
  • Participants enrolling in Part B of the study must have Ann Arbor Stage I or II cH: with bulky mediastinal disease, or Stage III or IV
  • Participants enrolling in Part C of the study must have Ann Arbor Stage I or II cHL without bulky disease
  • Histologically confirmed cHL according to the current World Health Organization (WHO) Classification
  • Bidimensional measurable disease as documented by PET/CT or CT imaging
  • Age 12 years or older in the United States. For regions outside of the US, participants must 18 years or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Who cannot join

  • Nodular lymphocyte predominant HL
  • History of another malignancy within 3 years of the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk or metastasis or death. Participants with nonmelanoma skin cancer, localized prostate cancer, or carcinoma in situ of any type are not excluded if they have undergone complete resection
  • Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 4 weeks of the first study drug dose
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Active cerebral/meningeal disease related to the underlying malignancy
  • Any active Grade 3 or higher viral, bacterial, or fungal infection within two weeks of the first dose of study drug (Grade 3 defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events, NCI CTCAE Version 4.03)
Show all 18Show fewer
  • Current therapy with other systemic anti-neoplastic or investigational agents
  • Planned consolidative radiotherapy (Parts B and C only)
  • Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity (Parts B and C only)
  • Grade 3 or higher pulmonary disease unrelated to underlying malignancy
  • Documented history of idiopathic interstitial pneumonia or diffusing capacity of the lung for carbon monoxide <50% predicted
  • History of a cerebral vascular event within 6 months of first dose of study drug
  • Child-Pugh B or C hepatic impairment
  • Grade 2 or higher peripheral sensory or motor neuropathy
  • Participants with acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment or as prophylaxis against GvHD
  • Previous treatment with brentuximab vedotin
  • Participants who are pregnant or breastfeeding
  • Other serious condition that would impair the participant's ability to receive or tolerate the planned treatment and follow-up

Trial locations and contacts

76 sites in 6 countries.

76 sites in 6 countries

United States55 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12208

  • Rocky Mountain Cancer Centers - Aurora

    Aurora, Colorado, 80012

  • Texas Oncology - Austin Midtown

    Austin, Texas, 78705

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • New Jersey Hematology Oncology Associates, LLC

    Brick, New Jersey, 08724

  • Medical University of South Carolina/Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic, The

    Cleveland, Ohio, 44195

  • University of Colorado Health Memorial Hospital

    Colorado Springs, Colorado, 80909

  • Texas Oncology - Medical City Dallas

    Dallas, Texas, 75230

  • Cancer Centers of Colorado - Denver

    Denver, Colorado, 80218

  • Karmanos Cancer Institute / Wayne State University

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Minnesota Oncology Hematology P.A.

    Edina, Minnesota, 55435

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Texas Oncology - Flower Mound

    Flower Mound, Texas, 75028

  • Poudre Valley Health System (PVHS)

    Fort Collins, Colorado, 80528

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Texas Oncology - Fort Worth 12th Avenue

    Fort Worth, Texas, 76104

  • Los Angeles Cancer Network / Compassionate Care Research Group

    Fountain Valley, California, 92708

  • Regional Cancer Care Associates - Freehold

    Freehold, New Jersey, 07728

  • SCL Health - St. Mary's Hospital & Medical Center

    Grand Junction, Colorado, 81501

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center / University of Texas

    Houston, Texas, 77030-4095

  • Regional Cancer Care Associates - Howell

    Howell Township, New Jersey, 07731

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • University of Tennessee

    Knoxville, Tennessee, 37920

  • Cardinal Bernardin Cancer Center / Loyola University Medical Center

    Maywood, Illinois, 60153

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176

  • Morristown Medical Center/ Carol G. Simon Cancer Center

    Morristown, New Jersey, 07960

  • Regional Cancer Care Associates - Mount Holly

    Mount Holly, New Jersey, 08060

  • CareMount Medical Group

    Mount Kisco, New York, 10549-3412

  • Tennessee Oncology-Nashville/Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Vista Oncology Inc PS

    Olympia, Washington, 98506

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Clinical Research Alliance - Abraham Mittelman, MD, LLC

    Purchase, New York, 10577

  • Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care

    Salem, Virginia, 24153

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas, 78240

  • Seattle Cancer Care Alliance / University of Washington

    Seattle, Washington, 98109-1023

  • Regional Cancer Care Associates - Central Jersey

    Somerville, New Jersey, 08876

  • Regional Cancer Care Associates - Sparta

    Sparta, New Jersey, 07871

  • Washington University in St Louis

    St Louis, Missouri, 63110

  • Florida Cancer Specialists - North Region

    St. Petersburg, Florida, 33705

  • Toledo Clinic Cancer Center

    Toledo, Ohio, 43623

  • Texas Oncology - Northeast Texas

    Tyler, Texas, 75702

  • Clinical Research Alliance - Morton Coleman, MD

    Westbury, New York, 11590

  • Wake Forest Baptist Medical Center / Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

Spain10 sites

  • Hospital del Mar

    Barcelona, Other, 08003

  • Hospital Universitari Vall d'Hebron

    Barcelona, Other, 08035

  • Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

    Barcelona, Other, 08908

  • Hospital Universitario de Girona Doctor Josep Trueta

    Girona, Other, 17007

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Other, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, Other, 28041

  • Hospital Puerta de Hierro Majadahonda

    Majadahonda, Other, 28222

  • Hospital Universitario Central de Asturias

    Oviedo, Other, 33011

  • Hospital Clinico Universitario de Salamanca

    Salamanca, Other, 37007

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, Other, 46026

Other trials in Spain

Australia4 sites

  • Royal Adelaide Hospital

    Adelaide, Other, 5000

  • Ballarat Regional Integrated Cancer Care

    Ballarat, Other, 3350

  • Monash Medical Centre

    Clayton, Other, 3168

  • Epworth Healthcare

    Victoria, Other, 3002

Other trials in Australia

Italy4 sites

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, Other, 25123

  • IRCSS Policlinico San Matteo

    Pavia, Other, 27100

  • Azienda Ospedaliera Universitaria Senese

    Siena, Other, 53100

  • Azienda Ospedaliera Citta della Salute e della Scienza di Torino

    Torino, Other, 10126

Other trials in Italy

Czechia2 sites

  • Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

    Hradec Králové, Other, 500 05

  • Fakultni Nemocnice Kralovske Vinohrady

    Prague, Other, 100 34

Other trials in Czechia

Poland1 site

  • Pratia MCM Krakow

    Krakow, Other, 30-727

Other trials in Poland

About this study

Official title: Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects

This trial will study two treatment combinations for classical Hodgkin lymphoma (cHL). This trial will find out if these two treatment combinations work to treat cHL. It will also find out what side effects occur. A side effect is anything the drug does besides treating cancer. This study will have three parts (Parts A, B, and C).

The drugs used in Part A are a combination of targeted anticancer drug (brentuximab vedotin) and three chemotherapy drugs (doxorubicin, vinblastine, and dacarbazine). These four drugs are called "A+AVD." Participants will be treated with granulocyte colony stimulating factor (G-CSF) following every dose of A+AVD for 6 cycles of treatment (12 doses).

Read more

Part A will look at whether the A+AVD drug combination reduces the number of participants who experience the side effect of febrile neutropenia. Febrile neutropenia is a very low white blood cell count and a fever, which can be life threatening.

Parts B and C will use drug combination of brentuximab vedotin, plus nivolumab, doxorubicin, and dacarbazine. These four drugs are called "AN+AD." Parts B and C will study how well the drugs work to treat cHL and what side effects they cause.

Read the detailed description

This study will have three parts.

Part A of the study is designed to evaluate the incidence of febrile neutropenia, efficacy, and dose intensity in participants with advanced stage classical Hodgkin lymphoma (cHL) receiving granulocyte colony stimulating factor primary prophylaxis (G-PP) administration during treatment with frontline A+AVD. In Part A, participants will be treated with granulocyte colony stimulating factor (G-CSF) following every dose of A+AVD for 6 cycles of treatment. Participants will be treated using institutional standard of care practices for the majority of treatment decisions.

Part B is designed to evaluate the combination of brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine (AN+AD) as frontline treatment in participants with advanced cHL. In Part B, participants will be given AN+AD combination for 6 cycles of treatment. This part of the trial will look at whether this combination of drugs is effective and tolerable in participants with Stage II with bulky mediastinal disease and Stage III or IV cHL.

Part C is designed to evaluate AN+AD as frontline treatment in participants with early stage cHL. In Part C, participants will be given AN+AD combination for 4 cycles of treatment. This part of the trial will look at whether this combination of drugs is effective and tolerable in participants with Stage I or II cHL with non-bulky mediastinal disease.

Being tested
brentuximab vedotin, doxorubicin, vinblastine, dacarbazine, G-CSF
Keywords
Brentuximab vedotin, Doxorubicin, Vinblastine, Dacarbazine, Nivolumab, Seattle Genetics
Medical subject headings
Hodgkin Disease

What participants receive

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

  • brentuximab vedotinDrug

    Also called Adcetris, SGN-35

    1.2 mg/kg by IV infusion

  • doxorubicinDrug

    25 mg/m^2 by IV infusion

  • vinblastineDrug

    6 mg/m^2 by IV infusion

  • dacarbazineDrug

    375 mg/m^2 by IV infusion

  • G-CSFDrug

    Also called filgrastim, pegfilgrastim

    Granulocyte colony stimulating factor (G-CSF) primary prophylaxis administered 24-36 hours after each dose of A+AVD

  • nivolumabDrug

    Also called Opdivo

    240 mg by IV infusion

Study groups in NCT03646123
Study groupRoleWhat they receive
Part A: A+AVDExperimentalBrentuximab vedotin (A) plus doxorubicin (+A), vinblastine (V), and dacarbazine (D) administered by intravenous (IV) infusion in participants with advanced stage classical Hodgkin lymphoma (cHL) during each treatment cycle.
Receives: Drug: brentuximab vedotin; Drug: doxorubicin; Drug: vinblastine; Drug: dacarbazine; Drug: G-CSF
Part B: AN+ADExperimentalBrentuximab vedotin (A) plus nivolumab (N), doxorubicin (+A), and dacarbazine (D) administered separately by IV infusion in participants with Stage II bulky mediastinal disease and Stage III or IV cHL during each treatment cycle.
Receives: Drug: brentuximab vedotin; Drug: doxorubicin; Drug: dacarbazine; Drug: nivolumab
Part C: AN+ADExperimentalBrentuximab vedotin (A) plus nivolumab (N), doxorubicin (+A), and dacarbazine (D) administered separately by IV infusion in participants with Stage I or II cHL with non-bulky mediastinal disease during each treatment cycle.
Receives: Drug: brentuximab vedotin; Drug: doxorubicin; Drug: dacarbazine; Drug: nivolumab

What is being measured

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

  1. Febrile Neutropenia (FN) Rate (Part A)

    The FN rate is defined as the number of participants who experience treatment-emergent FN.

    Measured: 7.5 months

  2. Complete Response (CR) Rate at EOT (Parts B and C)

    CR rate at EOT is defined as the percentage of participants with CR at EOT, according to the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Cheson 2016), in participants with previously untreated cHL.

    Measured: 7.8 months

Secondary outcomes (20)

  1. Number of Participants With Adverse Events of Clinical Interest (AECI) (Part A)

    An adverse event (AE) was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with the treatment. Participants with peripheral neuropathy (PN) adverse events were summarized under AECI.

    Measured: Approximately up to 7.5 months

  2. Primary Refractory Disease Rate (Part A)

    The primary refractory disease rate is defined as the percentage of participants with less than complete response or relapse within 3 months of EOT, according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas

    Measured: 10.2 months

  3. Complete Response Rate (Part A)

    The complete response rate is defined as the percentage of participants with CR at EOT according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Cheson 2014).

    Measured: 7.2 months

  4. Physician-reported Progression Free Survival (PFS) (Part A)

    The physician-reported PFS rate at 2 years is estimated based on Kaplan-Meier methodology. The determination of antitumor activity will be based on response assessments made according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Cheson 2014).

    Measured: 24 months

  5. Number of Participants With Subsequent Anticancer Therapy Utilization (Part A)

    Number of participants with subsequent anticancer therapy have been reported in this outcome measure.

    Measured: 33.8 months

  6. Actual Dose Intensity: Brentuximab Vedotin (Part A)

    Measured: 6.5 months

  7. Actual Dose Intensity: Doxorubicin, Vinblastine, Dacarbazine (Part A)

    Measured: 6.5 months

  8. Relative Dose Intensity (Part A)

    Measured: 6.5 months

  9. Rate of Dose Reduction and Delays: Brentuximab Vedotin (Part A)

    Measured: 6.5 months

  10. Rate of Dose Reduction and Delays: Doxorubicin (Part A)

    Measured: 6.5 months

  11. Rate of Dose Reduction and Delays: Vinblastine (Part A)

    Measured: 6.5 months

  12. Rate of Dose Reduction and Delays: Dacarbazine (Part A)

    Measured: 6.5 months

  13. Incidence of Adverse Events (Parts B and C)

    Measured: 8.9 months

  14. Incidence of Laboratory Abnormalities (Parts B and C)

    Laboratory values were graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). As per NCI CTCAE version 4.03 grading, Grade 1 indicated mild or asymptomatic laboratory abnormalities, Grade 2 indicated moderate laboratory abnormalities, and Grade 3 indicated severe and 4 indicated life-threatening laboratory abnormalities.

    Measured: 8.9 months

  15. Overall Response Rate (ORR) at EOT (Parts B and C)

    ORR is defined as the percentage of participants with CR or partial response (PR) at EOT according to the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016) in participants with previously untreated cHL.

    Measured: Up to 7.8 months

  16. Duration of Response (DOR) at End of Study (Parts B and C)

    DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016) or death, whichever came first. Duration of response was only calculated for the subgroup of participants achieving a CR or PR. Participants without progression or death were censored on the date of the last radiological assessment of measured lesions. Kaplan-Meier method was used.

    Measured: Up to 51.1 months

  17. Duration of Complete Response (DOCR) (Parts B and C)

    DOCR was defined as the time from start of the first documentation of CR to the first documentation of tumor progression (per the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016) or death, whichever came first. DOCR was calculated for the subgroup of participants achieving CR. Participants without progression or death were censored on the date of the last radiological assessment of measured lesions. Kaplan-Meier method was used.

    Measured: Up to 51.1 months

  18. Event Free Survival (EFS) Rate (Parts B and C)

    EFS was defined as the time from the start of study treatment to the first documentation of objective tumor progression, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or progressive disease, whichever occurred first. The determination of antitumor activity will be based on objective response assessments made according to Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016). Participants without progression or death were censored on the date of the last radiological assessment of measured lesions. EFS rate was percentage of participants with EFS.

    Measured: Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42

  19. PFS Rate (Parts B and C)

    PFS was defined as the time from start of study treatment to first documentation of objective tumor progression or death. The determination of antitumor activity will be based on objective response assessments made according to Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016). Participants without progression or death were censored on the date of the last radiological assessment of measured lesions. Kaplan-Meier method was used.

    Measured: At months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 from the start of study treatment

  20. Overall Survival (OS) Rate (Parts B and C)

    OS was defined as the time from start of study treatment to date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Kaplan-Meier method was used.

    Measured: At months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 from the start of study treatment

Timeline

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

  1. First posted24 Aug 2018
  2. Study start28 Jan 2019
  3. Primary completion7 Nov 2022
  4. Study completion23 Aug 2024

Why it stopped: The study was prematurely discontinued as the sponsor believes the data collected is enough to show the safety and efficacy of the combinations studied in all cohorts. The decision was not based on any safety and/or efficacy concerns.

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03646123
Sponsor's protocol ID
SGN35-027
Status last verified
Aug 2025
First submitted
22 Aug 2018
Last updated
28 Aug 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Abramson JS, Straus DJ, Bartlett NL, Burke JM, Lynch RC, Domingo Domenech E, Hess B, Schuster SR, Linhares Y, Gandhi M, Shah HR, Jurczak W, Re A, Hahn U, Prince HM, Guo W, Davis G, Ho L, Fanale M, Yasenchak CA, Lee HJ. Study of brentuximab vedotin combination treatment in people with early-stage Hodgkin lymphoma: a plain language summary. Future Oncol. 2026 Jul;22(17):2027-2040. doi: 10.1080/14796694.2026.2693614. Epub 2026 Jul 6.

    PubMed 42405616

  • Abramson JS, Straus DJ, Bartlett NL, Burke JM, Lynch RC, Domingo Domenech E, Hess B, Schuster SR, Linhares Y, Gandhi M, Shah HR, Jurczak W, Re A, Hahn U, Prince HM, Guo W, Davis G, Ho L, Fanale M, Yasenchak CA, Lee HJ. Brentuximab vedotin and nivolumab in combination with chemotherapy for nonbulky, early-stage classical Hodgkin lymphoma. Blood. 2026 Apr 9;147(15):1713-1722. doi: 10.1182/blood.2025030190.

    PubMed 41460964

  • Lee HJ, Ramchandren R, Friedman J, Melear J, Flinn IW, Burke JM, Linhares Y, Gonzales P, Peterson M, Raval M, Chintapatla R, Feldman TA, Yimer H, Islas-Ohlmayer M, Patel A, Metheny L, Dean A, Rana V, Gandhi MD, Renshaw J, Ho L, Fanale MA, Guo W, Yasenchak CA. Brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine for advanced-stage classical Hodgkin lymphoma. Blood. 2025 Jan 16;145(3):290-299. doi: 10.1182/blood.2024024681.

    PubMed 39622165

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing brentuximab vedotin, doxorubicin and vinblastine in people with Hodgkin Lymphoma, run by Seagen Inc. at 76 sites in 6 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 8 inclusion and 18 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: stopped early, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Spain, Australia, Italy, Czechia and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 21 Dec 2023). 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?

Febrile Neutropenia (FN) Rate (Part A) (time frame: 7.5 months). The study lists 2 primary outcomes in all. 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 NCT03646123, which also lists 3 linked publications.

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 28 Aug 2025.

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