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Hodgkin LymphomaPhase 2NCT03947255

A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma

A Phase 2 study testing brentuximab vedotin in people with Hodgkin Lymphoma and Peripheral T Cell Lymphoma, run by Seagen Inc. at 19 sites in United States.

Terminated

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

Official record
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Trial summary

This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment. Read more about this study

Who is it for?
Ages 18 years and older
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
12 participants
Where
19 sitesUnited States
Study dates
28 Oct 2019to 6 Nov 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL
  • Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment
  • Documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin
  • Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
  • Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and for 6 months following last dose of study drug

Who cannot join

  • Previously discontinued brentuximab vedotin due to any Grade 3 or higher toxicity
  • Existing Grade 2 or higher peripheral neuropathy
  • Previously refractory to treatment with brentuximab vedotin
  • History of a cerebral vascular event, unstable angina, or myocardial infarction within 6 months prior to first dose
  • History of another malignancy within 3 years before first dose of study drug or any evidence of residual disease from previously diagnosed malignancy
  • Acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD
Show all 10Show fewer
  • Active cerebral/meningeal disease
  • History of progressive multifocal leukoencephalopathy (PML)
  • Active uncontrolled Grade 3 (per NCI CTCAE v5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose of study drug
  • Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Pacific Cancer Medical Center

    Anaheim, California, 92801

  • University of Maryland

    Baltimore, Maryland, 21201

  • Medical University of South Carolina/Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Texas Oncology - Fort Worth

    Dallas, Texas, 75246

  • Karmanos Cancer Institute / Wayne State University

    Detroit, Michigan, 48201

  • Northwest Oncology and Hematology/AMITA

    Elk Grove Village, Illinois, 60007

  • Summit Medical Group

    Florham Park, New Jersey, 07932

  • Texas Oncology - Fort Worth 12th Avenue

    Fort Worth, Texas, 76104

  • The Center for Cancer and Blood Disorders: Fortworth

    Fort Worth, Texas, 76104

  • MD Anderson Cancer Center / University of Texas

    Houston, Texas, 77030-4095

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

  • SCL Health Good Samaritan Medical Center Cancer Centers of Colorado

    Lafayette, Colorado, 80026

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Cardinal Bernardin Cancer Center / Loyola University Medical Center

    Maywood, Illinois, 60153

  • Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • Memorial Cancer Institute

    Pembroke Pines, Florida, 33028

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas, 78240

  • Saint Louis University

    St Louis, Missouri, 63103

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Single-arm Study of Retreatment With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classic Hodgkin Lymphoma (cHL) or CD30-expressing Peripheral T Cell Lymphoma (PTCL)

This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment.

Read the detailed description

This is a study to determine the safety and efficacy of brentuximab vedotin in subjects with classic Hodgkin lymphoma (cHL) and systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T cell lymphoma (PTCL) who experienced complete response (CR) or partial response (PR) with a brentuximab vedotin-containing regimen and subsequently experienced disease progression or relapse.

Being tested
brentuximab vedotin
Keywords
CD30-expression, sALCL, PTCL, cHL, Seattle Genetics
Medical subject headings
Hodgkin Disease, Lymphoma, T-Cell, Peripheral, Lymphoma, Large-Cell, Anaplastic

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

    1.8 mg/kg given intravenously (IV)

Study groups in NCT03947255
Study groupRoleWhat they receive
Brentuximab vedotinExperimentalNot described
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) Per BICR According to Modified Lugano Response Criteria

    Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on BICR

    Measured: Up to 18.3 months

  2. Number of Participants With Adverse Events

    An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment.

    Measured: Up to 36 months

  3. Number of Participants With Laboratory Abnormalities

    Laboratory data was summarized by the worst post-baseline grade, by NCI CTCAE v5.0 or higher for each parameter.

    Measured: Up to 36 months

Secondary outcomes (9)

  1. Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria

    Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first.

    Measured: Up to 17.1 months

  2. Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria

    PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first.

    Measured: up to 18.3 months

  3. Overall Survival (OS)

    OS is defined as the time from date of enrollment to date of death due to any cause.

    Measured: Up to 35.8 months

  4. Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria

    CR rate is defined as the percentage of participants with CR according to the modified Lugano Criteria for Response Assessment (Cheson 2014)

    Measured: Up to 18.3 months

  5. ORR Per Investigator Assessment According to Modified Lugano Response Criteria

    Objective Response Rate (ORR) is defined as the percentage of participants with CR or PR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on investigator assessment

    Measured: Up to 18.3 months

  6. DOR Per Investigator Assessment According to Modified Lugano Response Criteria

    Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first.

    Measured: Up to 17.1 months

  7. Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria

    PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first.

    Measured: Up to 18.3 months

  8. Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria

    CR rate is defined as the percentage of participants with CR according to the Modified Lugano Criteria for Response Assessment (Cheson 2014).

    Measured: Up to 18.3 months

  9. ORR Per BICR According to Lugano Response Criteria

    ORR is defined as the percentage of participants with CR or PR, assessed according to Lugano Criteria for Response Assessment (Cheson 2014)

    Measured: Up to 18.3 months

Timeline

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

  1. First posted13 May 2019
  2. Study start28 Oct 2019
  3. Primary completion6 Nov 2022
  4. Study completion6 Nov 2022

Why it stopped: Study stopped early due to low patient accrual.

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03947255
Sponsor's protocol ID
SGN35-028
Status last verified
Oct 2023
First submitted
9 May 2019
Last updated
13 Oct 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing brentuximab vedotin in people with Hodgkin Lymphoma and Peripheral T Cell Lymphoma, run by Seagen Inc. at 19 sites in United States.

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 10 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 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. 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 13 Oct 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?

Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria (time frame: Up to 18.3 months). The study lists 3 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 NCT03947255.

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 13 Oct 2023.

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