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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT04300803
Eligibility Criteria:
Major Inclusion Criteria :
1. Age ≥ 18 years
2. Patient able to provide written informed consent
3. Histologically-confirmed diagnosis of DLBCL, including transformation from an earlier diagnosis of indolent lymphoma.
4. Patients must have relapsed and/or refractory DLBCL, including primary refractory disease and double/triple hit status, after at least 1 prior anti-CD20 containing regimen.
5. Patients with a serious, life-threatening illness in which conventional therapies have failed, are unsuitable and/or are unavailable and participation in ongoing relevant clinical trials is not feasible.
Major Exclusion Criteria:
1. Patients who have other histological type of lymphoma, e.g. indolent Non-Hodgkin lymphoma (NHL), Primary mediastinal B-cell lymphoma (PMBL) or Burkitt Lymphoma
2. Patients who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period with lenalidomide
3. Patients with:
1. Known active bacterial and viral and fungal infections
2. Serology of chronic active viral Hepatitis B and/or C-Hepatitis
3. Known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)
4. Patients who are unable to participate in the lenalidomide REMS program
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04300803
Study Brief:
Protocol Section:
NCT04300803