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

NCT ID: NCT01196208

Last Updated: 2020-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

brentuximab vedotin

Every 21 days by intravenous infusion (1.8 mg/kg)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SGN-35

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

Seagen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Liga Ulmane, MD

Role: STUDY_DIRECTOR

PSI Company Ltd.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford Cancer Center

Stanford, California, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

MD Anderson Cancer Center / University of Texas

Houston, Texas, United States

Site Status

Peter MacCallum Cancer Center

Melbourne, , Australia

Site Status

Leuven University Hospital

Leuven, , Belgium

Site Status

Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno

Sofia, , Bulgaria

Site Status

Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania

Sofia, , Bulgaria

Site Status

Hopital Saint-Louis/Service d'Hematologie

Paris, Cedex 10, France

Site Status

South Lyon Hospital Center, Department of Dermatology

Lyon, , France

Site Status

Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

Rouen, , France

Site Status

Johannes Wesling Hospital Minden, Department of Dermatology

Minden, , Germany

Site Status

Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly

Budapest, , Hungary

Site Status

Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika

Debrecen, , Hungary

Site Status

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

Szeged, , Hungary

Site Status

Polyclinic S. Orsola-Malpighi, Institute of Hematology and Medical Oncology "Lorenzo and Ariosto Seragnoli"

Bologna, , Italy

Site Status

IRCCS University Hospital San Martino

Genoa, , Italy

Site Status

Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

Lodz, , Poland

Site Status

Klinika Hematologii, Instytut Hematologii i Transfuzjologii

Warsaw, , Poland

Site Status

Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

Warsaw, , Poland

Site Status

Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular

Târgu Mureş, Mureș County, Romania

Site Status

Fundeni Clinical Institute, Center for Hematology and Bone Marrow Transplantation

Bucharest, , Romania

Site Status

Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu

Bucharest, , Romania

Site Status

Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN

Moscow, , Russia

Site Status

Gematologicheskj nauchnyj centr RAMN

Moscow, , Russia

Site Status

Research Institute of Clinical Immunology

Novosibirsk, , Russia

Site Status

Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova

Saint Petersburg, , Russia

Site Status

Clinical Center of Serbia, Clinic of Hematology

Belgrade, , Serbia

Site Status

University Hospital 12 de Octubre, Department of Dermatology

Madrid, , Spain

Site Status

University Hospital Zurich, Department of Dermatology

Zurich, , Switzerland

Site Status

Queen Elizabeth Hospital

Birmingham, , United Kingdom

Site Status

St John's Institute of Dermatology

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Belgium Bulgaria France Germany Hungary Italy Poland Romania Russia Serbia Spain Switzerland United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010-020363-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SGN35-010

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.