Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma

• Status: Active, not recruiting
• Trial end date: 2024-10-04
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-arm, open-label, multicenter, phase 4 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with relapsed or refractory Systemic Anaplastic Large Cell Lymphoma (SALCL).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Brentuximab Vedotin

Criteria

Inclusion Criteria:

• Male or female patients age 18 years or older, with relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy

• Bidimensional measurable disease

• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Female patients who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence

• Male patients who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence

• Clinical laboratory values as specified in the study protocol

Exclusion Criteria:

• Previous treatment with brentuximab vedotin.

• Previously received an allogeneic transplant.

• Patients with current diagnosis of primary cutaneous ALCL (patients whose ALCL has transformed to sALCL are eligible).

• Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)

• Female patients who are lactating and breastfeeding or pregnant

• Known human immunodeficiency virus (HIV) positive

• Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection