A treatment-option study of brentuximab vedotin in patients with progression of Hodgkin lymphoma or systemic anaplastic large cell lymphoma

Conditions: Hodgkin lymphomaAnaplastic large cell lymphoma
MedDRA version: 14.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.0Level: LLTClassification code 10065864Term: Anaplastic large-cell lymphoma, primary systemic typeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-020363-21-CZ

Lead Sponsor: Seattle Genetics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 380

Inclusion Criteria

• Participated in the placebo arm of the SGN35-005 clinical study and experienced disease progression of HL as defined by the SGN35-005 study protocol. Or in the US only; Patients with relapsed or refractory HL or patients with relapsed or refractory systemic ALCL who have previously failed frontline chemotherapy.
• 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: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 330
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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
• Patients who are eligible to participate in other brentuximab vedotin clinical studies

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To provide the option of treatment with brentuximab vedotin for those patients allocated on the placebo arm in study SGN35-005 who experience progression of Hodgkin lymphoma (HL)<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 systemic anaplastic large cell lymphoma (ALCL).;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