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:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
NCT ID:
NCT01716806
Eligibility Criteria:
Inclusion Criteria:
* Parts A, B, C, and D: 60 years of age or older
* Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
* Treatment-naive patients with CD30-expressing PTCL (Part F)
* Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
* Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:
* A CIRS score of 10 or greater
* Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs)
* Measurable disease of at least 1.5 cm as documented by radiographic technique
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)
Exclusion Criteria:
* Symptomatic neurologic disease compromising IADLs or requiring medication
* History of progressive multifocal leukoencephalopathy
* Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin
* Concurrent use of other investigational agents
* Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
* History of another malignancy within 1 year before first dose of study drug (Parts E and F only)
* Part D only:
* Received any prior immune-oncology therapy
* History of known or suspected autoimmune disease
* Prior allogeneic stem cell transplant
* History of cerebral vascular event within 6 months of first dose of study drug
* Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology
* Known history of pancreatitis
* Parts D, E, and F only:
* Known cerebral/meningeal disease related to the underlying malignancy
* Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01716806
Study Brief:
Protocol Section:
NCT01716806