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

Lymphoma, Non-Hodgkin Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01196208
• Other study ID #: SGN35-010
• Secondary ID: 2010-020363-21
• Status: No longer available

Study information

• Verified date: September 2020
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• brentuximab vedotin
Every 21 days by intravenous infusion (1.8 mg/kg)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.	Millennium Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  France,  Germany,  Hungary,  Italy,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  Switzerland,  United Kingdom,