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

Sponsor
Seagen Inc. (Industry)
Overall Status
No longer available
CT.gov ID
NCT01196208
Collaborator
Millennium Pharmaceuticals, Inc. (Industry)
31

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
  • Drug: brentuximab vedotin

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

Study Type:
Expanded Access
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    Seagen Inc.
    ClinicalTrials.gov Identifier:
    NCT01196208
    Other Study ID Numbers:
    • SGN35-010
    • 2010-020363-21
    First Posted:
    Sep 8, 2010
    Last Update Posted:
    Sep 21, 2020
    Last Verified:
    Sep 1, 2020

    Study Results

    No Results Posted as of Sep 21, 2020