A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
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 Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Stanford Cancer Center | Stanford | California | United States | 94305 |
2 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
3 | MD Anderson Cancer Center / University of Texas | Houston | Texas | United States | 77030-4003 |
4 | Peter MacCallum Cancer Center | Melbourne | Australia | 3002 | |
5 | Leuven University Hospital | Leuven | Belgium | 3000 | |
6 | Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno | Sofia | Bulgaria | 1527 | |
7 | Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania | Sofia | Bulgaria | 1756 | |
8 | Hopital Saint-Louis/Service d'Hematologie | Paris | Cedex 10 | France | 75475 |
9 | South Lyon Hospital Center, Department of Dermatology | Lyon | France | 69495 | |
10 | Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer | Rouen | France | 76038 | |
11 | Johannes Wesling Hospital Minden, Department of Dermatology | Minden | Germany | 32429 | |
12 | Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly | Budapest | Hungary | 1097 | |
13 | Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika | Debrecen | Hungary | 4004 | |
14 | Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont | Szeged | Hungary | 6720 | |
15 | Polyclinic S. Orsola-Malpighi, Institute of Hematology and Medical Oncology "Lorenzo and Ariosto Seragnoli" | Bologna | Italy | 40138 | |
16 | IRCCS University Hospital San Martino | Genoa | Italy | 16132 | |
17 | Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi | Lodz | Poland | 93-510 | |
18 | Klinika Hematologii, Instytut Hematologii i Transfuzjologii | Warsaw | Poland | 02-766 | |
19 | Centrum Onkologii Institut im. Marii Sklodowskiej-Curie | Warsaw | Poland | 02-781 | |
20 | Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular | Targu Mures | Judetul Mures | Romania | 540136 |
21 | Fundeni Clinical Institute, Center for Hematology and Bone Marrow Transplantation | Bucharest | Romania | 022328 | |
22 | Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu | Bucharest | Romania | 022328 | |
23 | Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN | Moscow | Russian Federation | 115478 | |
24 | Gematologicheskj nauchnyj centr RAMN | Moscow | Russian Federation | 125167 | |
25 | Research Institute of Clinical Immunology | Novosibirsk | Russian Federation | 630099 | |
26 | Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova | St. Petersburg | Russian Federation | 197101 | |
27 | Clinical Center of Serbia, Clinic of Hematology | Belgrade | Serbia | 11000 | |
28 | University Hospital 12 de Octubre, Department of Dermatology | Madrid | Spain | 28033 | |
29 | University Hospital Zurich, Department of Dermatology | Zurich | Switzerland | 8091 | |
30 | Queen Elizabeth Hospital | Birmingham | United Kingdom | ||
31 | St John's Institute of Dermatology | London | United Kingdom |
Sponsors and Collaborators
- Seagen Inc.
- Millennium Pharmaceuticals, Inc.
Investigators
- Study Director: Liga Ulmane, MD, PSI Company Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SGN35-010
- 2010-020363-21