A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001

September 17, 2020 updated by: Seagen Inc.

An Open-label, Treatment-option Protocol of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma, Systemic Anaplastic Large Cell Lymphoma, or CD30-positive Cutaneous T-cell Lymphoma

The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The protocol was amended to reflect the change from a phase 2/3 to a study with an expanded access program (EAP) in the US that would include patients with ALCL and HL. A later amendment allowed patients with CD30-positive cutaneous T-cell lymphoma to enroll. Enrollment may continue and patients may receive brentuximab vedotin treatment on study until the drug is commercially approved and available to patients in a geographic region.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia, 3002
        • Peter MacCallum Cancer Center
  • Belgium
      • Leuven, Belgium, 3000
        • Leuven University Hospital
  • Bulgaria
      • Sofia, Bulgaria, 1527
        • Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno
      • Sofia, Bulgaria, 1756
        • Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania
  • France
      • Lyon, France, 69495
        • South Lyon Hospital Center, Department of Dermatology
      • Rouen, France, 76038
        • Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
    • Cedex 10
      • Paris, Cedex 10, France, 75475
        • Hopital Saint-Louis/Service d'Hematologie
  • Germany
      • Minden, Germany, 32429
        • Johannes Wesling Hospital Minden, Department of Dermatology
  • Hungary
      • Budapest, Hungary, 1097
        • Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly
      • Debrecen, Hungary, 4004
        • Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
  • Italy
      • Bologna, Italy, 40138
        • Polyclinic S. Orsola-Malpighi, Institute of Hematology and Medical Oncology "Lorenzo and Ariosto Seragnoli"
      • Genoa, Italy, 16132
        • IRCCS University Hospital San Martino
  • Poland
      • Lodz, Poland, 93-510
        • Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
      • Warsaw, Poland, 02-766
        • Klinika Hematologii, Instytut Hematologii i Transfuzjologii
      • Warsaw, Poland, 02-781
        • Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
  • Romania
      • Bucharest, Romania, 022328
        • Fundeni Clinical Institute, Center for Hematology and Bone Marrow Transplantation
      • Bucharest, Romania, 022328
        • Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
    • Judetul Mures
      • Targu Mures, Judetul Mures, Romania, 540136
        • Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN
      • Moscow, Russian Federation, 125167
        • Gematologicheskj nauchnyj centr RAMN
      • Novosibirsk, Russian Federation, 630099
        • Research Institute of Clinical Immunology
      • St. Petersburg, Russian Federation, 197101
        • Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia, Clinic of Hematology
  • Spain
      • Madrid, Spain, 28033
        • University Hospital 12 de Octubre, Department of Dermatology
  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich, Department of Dermatology
  • United Kingdom
      • Birmingham, United Kingdom
        • Queen Elizabeth Hospital
      • London, United Kingdom
        • St John'S Institute of Dermatology
  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
    • Texas
      • Houston, Texas, United States, 77030-4003
        • MD Anderson Cancer Center / University of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participated in either the SGN35-005 or C25001 clinical study and experienced progression. Patients who received brentuximab vedotin in C25001 must have had an objective response at the time of discontinuation.
  • Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin

Exclusion Criteria:

  • History of another primary malignancy that has not been in remission for at least 3 years
  • Known cerebral/meningeal disease
  • Peripheral neuropathy of grade 2 or greater
  • Females who are pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seagen Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Millennium Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SGN35-010
  • 2010-020363-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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