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 lymphomaAnaplastic large cell lymphomaCD30-positive cutaneous T-cell lymphoma
MedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864
MedDRA version: 20.0Level: LLTClassification code 10011677Term: Cutaneous T-cell lymphomaSystem Organ Class: 100000004864
MedDRA version: 20.1Level: LLTClassification code 10065864Term: Anaplastic large-cell lymphoma, primary systemic typeSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-020363-21-DE

Lead Sponsor: Seattle Genetics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 460

Inclusion Criteria

-Participated in the 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
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.;Main Objective: ? To provide the option of treatment with brentuximab vedotin for patients in study SGN35-005 who experience progression of HL, and for those patients in study C25001 on the experimental arm with an objective response at the time of discontinuation of brentuximab vedotin or the control arm who experience progression of CD30+CTCL per 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).

Secondary Outcome Measures