Eligibility Module

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: 2025-12-24 @ 11:13 PM
Ignite Modification Date: 2025-12-24 @ 11:13 PM
NCT ID: NCT03235869
Eligibility Criteria: Inclusion Criteria: * Voluntarily provide written IRB-approved consent * Age ≥ 18 years * Histologically proven CTCL * Stage IIB-IV CTCL with ≥2 cutaneous tumors assessable for response * At least one cutaneous tumor amenable to radiation therapy. Must have at least 1 tumor assessable for response that will not undergo radiation. * Adequate organ function * Prior treatment is allowed if at least 4 weeks have elapsed since last chemotherapy and/or radiation and the subject has recovered from all treatment related toxicity Exclusion Criteria: * Prior allogeneic stem cell transplant. * Prior treatment with a PD-1/PD-L1 inhibitor * Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment. * Current or prior use of immunosuppressive medication within 14 days prior to first dose of durvalumab. * Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection. * History of hypersensitivity to durvalumab or any excipient * Receipt of live attenuated vaccination within 30 days prior the first dose of durvalumab. * Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control * Male subjects who are not employing an effective method of birth control * Uncontrolled current medical illness, including, but not limited to ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris,unstable cardiac arrhythmia and/or psychiatric illness or other condition that in the opinion of the investigator would limit compliance with study requirements.
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT03235869
Study Brief:
Protocol Section: NCT03235869