Clinical trial NCT01196208: A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001
Official title: 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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous
Keywords: Disease, Hodgkin
Lymphoma
Monomethylauristatin E
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Cutaneous
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Hematologic Diseases
Immunotherapy
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2010-09-08
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Houston
country: United States
facility: MD Anderson Cancer Center / University of Texas
state: Texas
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Center
city: Leuven
country: Belgium
facility: Leuven University Hospital
city: Sofia
country: Bulgaria
facility: Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno
city: Sofia
country: Bulgaria
facility: Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania
city: Paris
country: France
facility: Hopital Saint-Louis/Service d'Hematologie
state: Cedex 10
city: Lyon
country: France
facility: South Lyon Hospital Center, Department of Dermatology
city: Rouen
country: France
facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
city: Minden
country: Germany
facility: Johannes Wesling Hospital Minden, Department of Dermatology
city: Budapest
country: Hungary
facility: Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
city: Bologna
country: Italy
facility: Polyclinic S. Orsola-Malpighi, Institute of Hematology and Medical Oncology "Lorenzo and Ariosto Seragnoli"
city: Genoa
country: Italy
facility: IRCCS University Hospital San Martino
city: Lodz
country: Poland
facility: Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
city: Warsaw
country: Poland
facility: Klinika Hematologii, Instytut Hematologii i Transfuzjologii
city: Warsaw
country: Poland
facility: Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
state: Judetul Mures
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute, Center for Hematology and Bone Marrow Transplantation
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
city: Moscow
country: Russian Federation
facility: Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN
city: Moscow
country: Russian Federation
facility: Gematologicheskj nauchnyj centr RAMN
city: Novosibirsk
country: Russian Federation
facility: Research Institute of Clinical Immunology
city: St. Petersburg
country: Russian Federation
facility: Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia, Clinic of Hematology
city: Madrid
country: Spain
facility: University Hospital 12 de Octubre, Department of Dermatology
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Dermatology
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: London
country: United Kingdom
facility: St John's Institute of Dermatology
Study officials:
affiliation: PSI Company Ltd.
name: Liga Ulmane, MD
role: STUDY_DIRECTOR
References: