A treatment-option study of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma, systemic anaplastic large cell lymphoma, or CD30-positive cutaneous T-cell lymphoma

Phase 1

• Conditions: Hodgkin lymphoma Anaplastic large cell lymphoma CD30-positive cutaneous T-cell lymphoma; MedDRA version: 20.0 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma System Organ Class: 100000004864; MedDRA version: 20.0 Level: LLT Classification code 10011677 Term: Cutaneous T-cell lymphoma System Organ Class: 100000004864; MedDRA version: 20.1 Level: LLT Classification code 10065864 Term: Anaplastic large-cell lymphoma, primary systemic type System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-020363-21-GB
• Lead Sponsor: Seattle Genetics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-23
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 460

Inclusion Criteria

Participated in SGN35-005 clinical study and experienced disease progression of HL as defined by the SGN35-005 study protocol. Or,
patients in the C25001 clinical study on the control arm or patients on the experimental arm with an objective response at the time of
discontinuation of brentuximab vedotin who experienced disease progression. Or in the US only; Patients with relapsed or refractory HL
who have previously received an autologous SCT or patients with relapsed or refractory systemic ALCL who have previously failed frontline chemotherapy (Amendment 5 and later, not applicable).
Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first
dose of brentuximab vedotin, unless underlying disease is progressing on therapy.

Are the trial subjects under 18? yes
Number of subjects for this age range: 6
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 421
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

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 lactating and breastfeeding
-Patients who are eligible to participate in other brentuximab vedotin clinical studies (Amendment 5 and later, not applicable)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: •To provide the option of treatment with brentuximab vedotin for those patients on the placebo arm in study SGN35-005 who experience progression of Hodgkin lymphoma (HL), and for those patients in the control arm of study C25001 who experience progression of CD30- positive (CD30+) cutaneous T-cell lymphoma (CTCL) per independent review facility (IRF).<br> •To assess the safety and tolerability of brentuximab vedotin<br> •In the US only, to provide access to brentuximab vedotin for patients with relapsed or refractory HL and patients with relapsed or refractory anaplastic large cell lymphoma (ALCL).<br> ;Secondary Objective: Not applicable.;Primary end point(s): The safety endpoints are the type, incidence, severity, seriousness, and study drug relatedness of adverse events (AEs).;Timepoint(s) of evaluation of this end point: From study enrolment through 1 month after each patient's last dose.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.