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Hodgkin DiseasePhase 2NCT01716806

A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

A Phase 2 study testing brentuximab vedotin, bendamustine and dacarbazine in people with Hodgkin Disease and Peripheral T Cell Lymphoma, run by Seagen Inc. at 54 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin Disease, Peripheral T Cell Lymphoma
What is being tested?
brentuximab vedotin, bendamustine and dacarbazine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
54 sitesin 2 countries
Study dates
31 Oct 2012to 12 Sep 2023
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

  • Parts A, B, C, and D: 60 years of age or older
  • Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
  • Treatment-naive patients with CD30-expressing PTCL (Part F)
  • Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
  • Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:
  • A CIRS score of 10 or greater
Show all 9Show fewer
  • Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs)
  • Measurable disease of at least 1.5 cm as documented by radiographic technique
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)

Who cannot join

  • Symptomatic neurologic disease compromising IADLs or requiring medication
  • History of progressive multifocal leukoencephalopathy
  • Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin
  • Concurrent use of other investigational agents
  • Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
  • History of another malignancy within 1 year before first dose of study drug (Parts E and F only)
Show all 16Show fewer
  • Part D only:
  • Received any prior immune-oncology therapy
  • History of known or suspected autoimmune disease
  • Prior allogeneic stem cell transplant
  • History of cerebral vascular event within 6 months of first dose of study drug
  • Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology
  • Known history of pancreatitis
  • Parts D, E, and F only:
  • Known cerebral/meningeal disease related to the underlying malignancy
  • Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment

Trial locations and contacts

54 sites in 2 countries.

54 sites in 2 countries

United States49 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12208

  • Alaska Urological Institute

    Anchorage, Alaska, 99503

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • Rocky Mountain Cancer Centers - Aurora

    Aurora, Colorado, 80012

  • Texas Oncology - Bedford

    Bedford, Texas, 76022

  • American Oncology Networks LLC

    Bethesda, Maryland, 20817

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Providence St Joseph Medical Center

    Burbank, California, 91505

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • IACT Health

    Columbus, Georgia, 31904

  • James Cancer Hospital / Ohio State University

    Columbus, Ohio, 43210

  • Texas Oncology - Presbyterian Cancer Center Dallas

    Dallas, Texas, 75231

  • Texas Oncology - Denton South

    Denton, Texas, Kurkul

  • Karmanos Cancer Institute / Wayne State University

    Detroit, Michigan, 48201

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Texas Oncology - Fort Worth 12th Avenue

    Fort Worth, Texas, 76104

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Prisma Health

    Greenville, South Carolina, 29615

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

  • MD Anderson Cancer Center / University of Texas

    Houston, Texas, 77030

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Texas Oncology - Longview

    Longview, Texas, 75601

  • Carbone Cancer Center / University of Wisconsin

    Madison, Wisconsin, 53792

  • Texas Oncology - McAllen

    McAllen, Texas, 78503

  • Minnesota Oncology Hematology P.A.

    Minneapolis, Minnesota, 55404

  • University of South Alabama - Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • Morristown Medical Center/ Carol G. Simon Cancer Center

    Morristown, New Jersey, 07960

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Columbia University Medical Center

    New York, New York, 10032

  • Illinois Cancer Specialists / Advocate Lutheran General Hospital

    Niles, Illinois, 60714

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Wilshire Oncology Medical Group Inc.

    Pomona, California, 91767

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298

  • James P. Wilmot Cancer Center / University of Rochester Medical Center

    Rochester, New York, 14642

  • Texas Oncology - Seton Williamson

    Round Rock, Texas, 78665

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

    Salem, Virginia, 24153

  • Georgia Cancer Specialists / Northside Hospital Cancer Institute

    Sandy Springs, Georgia, 30341

  • Benaroya Research Institute/Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Highlands Oncology Group

    Springdale, Arkansas, J. Thaddeus Beck

  • Northwest Cancer Specialists, P.C.

    Tigard, Oregon, 97223

  • Florida Cancer Affiliates

    Trinity, Florida, 34655

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85710

  • Arizona Cancer Center / University of Arizona

    Tucson, Arizona, 85724-5024

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98821

  • Shenandoah Oncology P.C.

    Winchester, Virginia, 22601

Other trials in United States

Canada5 sites

  • University of Alberta / Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • London Health Sciences Centre - Victoria Hospital

    London, Ontario, N6A 5W9

  • CIUSSS de L'Est de l'lle de Montreal / installation Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Royal Victoria Hospital, McGill University Health Centre

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

Official title: A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) an dCD30-expressing Peripheral T-cell Lymphoma (PTCL) in Older Patients or Patients With Significant Comorbidities Ineligible for Standard Chemotherapy

This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.

Read the detailed description

This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as monotherapy and in combination with other agents as frontline therapy. There are 6 parts of the study. The population to be studied includes treatment-naïve patients with classical Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell lymphoma (PTCL).

Being tested
brentuximab vedotin, bendamustine, dacarbazine, nivolumab
Keywords
Antibody-Drug Conjugate, Antibodies, Monoclonal, Hematologic Diseases, Hodgkin Disease, Antigens, CD30, Lymphoma, monomethylauristatin E, Drug Therapy, CD30-expression, PTCL, Seattle Genetics
Medical subject headings
Hodgkin Disease, Lymphoma, T-Cell, Peripheral, Hematologic Diseases, Lymphoma

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 every 3 weeks by IV infusion

  • bendamustineDrug

    70 mg/m^2 by IV infusion on Days 1 and 2 of 3-week cycle

  • dacarbazineDrug

    375 mg/m^2 every 3 weeks by IV infusion

  • nivolumabDrug

    3 mg/kg every 3 weeks by IV infusion

Study groups in NCT01716806
Study groupRoleWhat they receive
Part A: Brentuximab Vedotin in HL PatientsExperimentalNot described
Receives: Drug: brentuximab vedotin
Part B: Brentuximab Vedotin + Dacarbazine in HL PatientsExperimentalNot described
Receives: Drug: brentuximab vedotin; Drug: dacarbazine
Part C: Brentuximab Vedotin + Bendamustine in HL PatientsExperimentalNot described
Receives: Drug: brentuximab vedotin; Drug: bendamustine
Part D: Brentuximab Vedotin + Nivolumab in HL PatientsExperimentalNot described
Receives: Drug: brentuximab vedotin; Drug: nivolumab
Part E: Brentuximab Vedotin in HL PatientsExperimentalNot described
Receives: Drug: brentuximab vedotin
Part F: Brentuximab Vedotin in PTCL PatientsExperimentalNot 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) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)

    Objective response rate (ORR) per investigator was defined as the percentage of subjects with complete response (CR) or partial response (PR) through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts A, B, and C the response was assessed using the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).

    Measured: Up to 81 months

  2. ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D)

    Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Part D, the response was assessed using the Lugano Classification Revised Staging System for nodal non-Hodgkin and cHL (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC).

    Measured: Up to 60 months

  3. ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F)

    Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts E and F, the response was assessed per blinded independent central review (BICR) using the modified Lugano criteria.

    Measured: Up to 31 months

Secondary outcomes (12)

  1. Number of Participants With Adverse Events

    A treatment-emergent AE (TEAE) is defined as a newly occurring or worsening AE after the first dose of any study drug component. Treatment-related AEs are defined as treatment-emergent AEs that are determined by the investigator to be related to the treatment on study. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.

    Measured: Up to 122 months

  2. Number of Participants With Laboratory Abnormalities

    Laboratory values were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.

    Measured: Up to 30 months

  3. Complete Response Rate

    Complete response rate is defined as the percentage of patients with CR

    Measured: Up to 81 months

  4. Duration of Complete Response

    Duration of CR per investigator was defined as the time from start of the first documentation of CR to the first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.

    Measured: Up to 81 months

  5. Duration of Objective Response

    Duration of response per investigator was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (PD) based on radiographic evidence of progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.

    Measured: Up to 81 months

  6. Progression-free Survival

    Progression-free survival (PFS) per investigator was defined as the time from start of study treatment to first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.

    Measured: Up to 83 months

  7. Disease Control Rate

    Disease control rate (DCR) per investigator was defined as the percentage of subjects with CR, PR, or SD, per investigator assessment of best clinical response per Cheson 2007. For Parts E and F, the assessment was per BICR.

    Measured: Up to 81 months

  8. ORR According to Lugano Criteria Per BICR (Parts E and F)

    Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment.

    Measured: Up to 31 months

  9. B Symptom Resolution Rate

    B symptom resolution rate per investigator was defined as the percentage of subjects with lymphoma-related B symptoms at baseline who achieved resolution of all B symptoms at any time during the treatment period.

    Measured: Up to 42 weeks

  10. Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA)

    Measured: Up to 30 months

  11. Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only)

    Measured: Up to 30 months

  12. Overall Survival (Parts E and F Only)

    Overall survival (OS) per investigator was defined as the time from date of enrollment to date of death due to any cause.

    Measured: Up to 44 months

Timeline

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

  1. First posted30 Oct 2012 (estimated)
  2. Study start31 Oct 2012
  3. Primary completion7 Apr 2023
  4. Study completion12 Sep 2023

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
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01716806
Sponsor's protocol ID
SGN35-015
Status last verified
May 2024
First submitted
16 Oct 2012
Last updated
11 Jun 2024
Data monitoring committee
No

Publications

  • Friedberg JW, Bordoni R, Patel-Donnelly D, Larson T, Goldschmidt J, Boccia R, Cline VJM, Mamidipalli A, Liu J, Akyol A, Yasenchak CA. Brentuximab vedotin with dacarbazine or nivolumab as frontline cHL therapy for older patients ineligible for chemotherapy. Blood. 2024 Feb 29;143(9):786-795. doi: 10.1182/blood.2022019536.

    PubMed 37946283

  • Friedberg JW, Forero-Torres A, Bordoni RE, Cline VJM, Patel Donnelly D, Flynn PJ, Olsen G, Chen R, Fong A, Wang Y, Yasenchak CA. Frontline brentuximab vedotin in combination with dacarbazine or bendamustine in patients aged >/=60 years with HL. Blood. 2017 Dec 28;130(26):2829-2837. doi: 10.1182/blood-2017-06-787200. Epub 2017 Oct 16.

    PubMed 29038340

  • Forero-Torres A, Holkova B, Goldschmidt J, Chen R, Olsen G, Boccia RV, Bordoni RE, Friedberg JW, Sharman JP, Palanca-Wessels MC, Wang Y, Yasenchak CA. Phase 2 study of frontline brentuximab vedotin monotherapy in Hodgkin lymphoma patients aged 60 years and older. Blood. 2015 Dec 24;126(26):2798-804. doi: 10.1182/blood-2015-06-644336. Epub 2015 Sep 16.

    PubMed 26377597

  • Gopal AK, Bartlett NL, Forero-Torres A, Younes A, Chen R, Friedberg JW, Matous JV, Shustov AR, Smith SE, Zain J, O'Meara MM, Fanale MA. Brentuximab vedotin in patients aged 60 years or older with relapsed or refractory CD30-positive lymphomas: a retrospective evaluation of safety and efficacy. Leuk Lymphoma. 2014 Oct;55(10):2328-34. doi: 10.3109/10428194.2013.876496. Epub 2014 Feb 24.

    PubMed 24359243

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing brentuximab vedotin, bendamustine and dacarbazine in people with Hodgkin Disease and Peripheral T Cell Lymphoma, run by Seagen Inc. at 54 sites in 2 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 9 inclusion and 16 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 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Canada. 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 11 Jun 2024). 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) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C) (time frame: Up to 81 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 NCT01716806, which also lists 4 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 11 Jun 2024.

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