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: 17.1Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864; MedDRA version: 17.1Level: LLTClassification code 10011677Term: Cutaneous T-cell lymphomaSystem Organ Class: 100000004864; MedDRA version: 17.1Level: LLTClassification code 10065864Term: Anaplastic large-cell lymphoma, primary systemic typeSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-05
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

- Participated in the SGN35-005 clinical study and experienced progression of HL as defined by the SGN35-005 study protocol.
Or,
Patients who met all Inclusion/Exclusion criteria for the the C25001 clinical study, and experienced disease progression per IRF: patients on he control arm or patients on the experimental arm with an objective response at the time of discontinuation of brentuximab vedotin.
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 and documented anaplastic lymphoma kinase(ALK) status (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
-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