Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT01909934
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01909934
Study Brief:
Protocol Section:
NCT01909934