Status:
COMPLETED
Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
Lead Sponsor:
Takeda
Collaborating Sponsors:
Takeda Development Center Americas, Inc.
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01909934
Start Date
January 23 2014
End Date
August 29 2024
Last Update
September 19 2025
Active Locations (40)
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1
ZNA Stuivenberg
Antwerp, Belgium, 2060
2
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
3
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
4
UZ Leuven
Leuven, Belgium, 3000