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Disease, HodgkinPhase 2NCT00848926

A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma

A Phase 2 study testing brentuximab vedotin in people with Disease, Hodgkin, run by Seagen Inc. at 27 sites in 5 countries.

Completed

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

Official record
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Trial summary

This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Disease, Hodgkin
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
102 participants
Where
27 sitesin 5 countries
Study dates
Feb 2009to May 2015
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

  • Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant.
  • Histologically confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.
  • Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm as documented by spiral computed tomography.
  • At US sites patients greater than or equal to 12 years of age may be enrolled. At non-US sites patients must be greater than or equal to 18 years of age.

Who cannot join

  • Previous treatment with brentuximab vedotin.
  • Previously received an allogeneic transplant.
  • Congestive heart failure, Class III or IV, by the New York Heart Association criteria.
  • History of another primary malignancy that has not been in remission for at least 3 years.
  • Known cerebral/meningeal disease.

Trial locations and contacts

27 sites in 5 countries.

27 sites in 5 countries

United States19 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3300

  • Ohio State University

    Columbus, Ohio, 43210

  • Baylor Sammons Cancer Center

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope National Medical Center

    Duarte, California, 91010-3000

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • University of California at Los Angeles

    Los Angeles, California, 90095

  • Loyola University Medical Center Cardinal Bernardin Cancer Center

    Maywood, Illinois, 60153

  • University of Miami

    Miami, Florida, 33136

  • Weill Cornell Medical College

    New York, New York, 10021

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Stanford University Medical Center

    Palo Alto, California, 94305

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of Washington

    Seattle, Washington, 98109

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

France3 sites

  • Institut Paoli Calmettes

    Marseille, 13273

  • Hospital Saint Louis

    Paris, 75475

  • Centre Henri Becquerel

    Rouen, 76038

Other trials in France

Belgium2 sites

  • UZ Gasthuisberg

    Leuven, 3000

  • Cliniques Universitaires UCL de Mont-Goddine

    Yvoir, 5530

Other trials in Belgium

Canada2 sites

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • B.C Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Italy1 site

  • Instituto di Ematologia ed Oncologia Medica

    Bologna, 40138

Other trials in Italy

About this study

Official title: A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.

Being tested
brentuximab vedotin
Keywords
Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Disease, Hodgkin, Hematologic Diseases, Lymphoma, monomethylauristatin E, Drug Therapy, Immunotherapy
Medical subject headings
Hodgkin Disease, 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 SGN-35, ADCETRIS

    1.8 mg/kg every 3 weeks by intravenous infusion

Study groups in NCT00848926
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 by Independent Review Group

    Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

    Measured: up to 12 months

Secondary outcomes (11)

  1. Complete Remission Rate by Independent Review Group

    Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

    Measured: up to 12 months

  2. Duration of Objective Response by Kaplan-Meier Analysis

    Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.

    Measured: up to approximately 4 years

  3. Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis

    Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.

    Measured: up to approximately 4 years

  4. Progression-free Survival by Kaplan-Meier Analysis

    Time from start of study treatment to disease progression per independent review group or death due to any cause.

    Measured: up to approximately 4 years

  5. Overall Survival

    Time from start of study treatment to date of death due to any cause.

    Measured: up to approximately 6 years

  6. Adverse Events by Severity, Seriousness, and Relationship to Treatment

    Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.

    Measured: up to 12 months

  7. Hematology Laboratory Abnormalities >/= Grade 3

    Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.

    Measured: up to 12 months

  8. Chemistry Laboratory Abnormalities >/= Grade 3

    Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.

    Measured: up to 12 months

  9. Area Under the Curve

    Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin

    Measured: 3 weeks

  10. Maximum Serum Concentration

    Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin

    Measured: 3 weeks

  11. Time of Maximum Serum Concentration

    Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin

    Measured: 3 weeks

Timeline

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

  1. First posted20 Feb 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionAug 2010
  4. Study completionMay 2015

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
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00848926
Sponsor's protocol ID
SG035-0003
Other IDs
2008-006034-10, 2008
Status last verified
Jun 2015
First submitted
18 Feb 2009
Last updated
13 Mar 2017
Data monitoring committee
Yes

Publications

  • Younes A, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Ramchandren R, Bartlett NL, Cheson BD, de Vos S, Forero-Torres A, Moskowitz CH, Connors JM, Engert A, Larsen EK, Kennedy DA, Sievers EL, Chen R. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. J Clin Oncol. 2012 Jun 20;30(18):2183-9. doi: 10.1200/JCO.2011.38.0410. Epub 2012 Mar 26.

    PubMed 22454421

  • Chen R, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Huebner D, Fong A, Younes A. Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2016 Sep 22;128(12):1562-6. doi: 10.1182/blood-2016-02-699850. Epub 2016 Jul 18.

    PubMed 27432875

  • Gopal AK, Chen R, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Chi X, Sievers EL, Younes A. Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma. Blood. 2015 Feb 19;125(8):1236-43. doi: 10.1182/blood-2014-08-595801. Epub 2014 Dec 22.

    PubMed 25533035

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing brentuximab vedotin in people with Disease, Hodgkin, run by Seagen Inc. at 27 sites in 5 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 4 inclusion and 5 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, France, Belgium, Canada, Italy. 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 26 Oct 2011). 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 by Independent Review Group (time frame: up to 12 months). 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 NCT00848926, 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 13 Mar 2017.

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