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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT04697160
Eligibility Criteria:
Eligibility Criteria:
1. Age ≥ 18 years at the initial DLBCL diagnosis.
2. One of the following histologically confirmed diagnosis: DLBCL not otherwise specified (NOS); T-cell/histiocyte rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive DLBCL), Grade 3b Follicular Lymphoma (FL), Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification. Additionally, patients with the evidence of histological transformation to DLBCL from an earlier diagnosis of low grade lymphoma (i.e., an indolent pathology such as FL, marginal zone lymphoma, chronic lymphocytic leukemia) into DLBCL with a subsequent DLBCL relapse are also eligible.
3. Relapsed or refractory DLBCL and received at least 2 systemic regimens for the treatment of DLBCL, including at least 1 anti-CD20 containing therapy.
Non-Eligibility Criteria:
1. Patients with central nervous system (CNS) involvement by lymphoma at initial DLBCL diagnosis.
2. Patients who were treated with CD19-targeted therapy or immunomodulatory drugs (IMiDs) (e.g., thalidomide, LEN) as a frontline DLBCL therapy.
3. Patients who underwent an allogeneic stem cell transplant.
4. Patients who had a prior history of malignancies other than DLBCL, unless the patient has been free of the disease for ≥5 years prior to inclusion.
Note: Patients with the following malignancies within the 5 years period are still eligible:
1. basal cell carcinoma of the skin
2. squamous cell carcinoma of the skin
3. carcinoma in situ of the cervix
4. carcinoma in situ of the breast
5. carcinoma in situ of the bladder
6. incidental histological finding of prostate cancer (Tumor/Node/Metastasis \[TNM\] stage of T1a or T1b)
5. Patients who received tafasitamab.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04697160
Study Brief:
Protocol Section:
NCT04697160