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

Takeda

Status and phase: Active, not recruiting; Phase 4

Conditions: Lymphoma

Treatments: Drug: Brentuximab vedotin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01909934

C25006

2012-004128-39 (EudraCT Number)

13/NI/0072 (Registry Identifier)

REec-2014-0649 (Registry Identifier)

U1111-1154-9784 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the antitumor efficacy of single-agent brentuximab vedotin 1.8 mg/kg administered intravenously (IV) every 3 weeks, as measured by the overall objective response rate (ORR) in patients with r/r sALCL following at least 1 multiagent chemotherapy regimen (cyclophosphamide, doxorubicin hydrochloride [hydroxydaunorubicin], vincristine sulfate [Oncovin], and prednisone [CHOP] or equivalent multiagent chemotherapy regimens with curative intent).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participants 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 participants 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 participants 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.
• Participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma [ALCL] (participants whose ALCL has transformed to sALCL are eligible).
• Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
• Female participants 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Brentuximab Vedotin 1.8 mg/kg

Experimental group

Description:

Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute intravenous (IV) infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.

Treatment:

Drug: Brentuximab vedotin