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 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT05338892
Eligibility Criteria:
Key Inclusion Criteria:
1. Have a histologically confirmed diagnosis of DLBCL on or after 01 Jan 2010 as defined in the protocol
2. Have been r/r to at least 2 lines of systemic therapy for DLBCL, including an anti-CD20 antibody and an alkylating agent as defined in the protocol
3. Have initiated at least one additional line (3L+) of systemic therapy (salvage therapy) for DLBCL between 01 Jan 2015 and 30 Jun 2021 (indexing period) after meeting the criteria for r/r DLBCL as described above; the first additional line of systemic therapy during the indexing period that meets all of the remaining inclusion and exclusion criteria defined below will be the patients' first qualifying salvage therapy.
4. Have measurable disease on cross sectional imaging (defined as at least 1 bi-dimensionally measurable nodal lesion ≥1.5 centimeter \[cm\] in the greatest transverse diameter \[GTD\] regardless of the short axis diameter) documented by diagnostic imaging (computed tomography \[CT\], or magnetic resonance imaging \[MRI\]) recorded on or during the 8 weeks prior to index date
5. Have been seen at a site that routinely assesses DLBCL treatment response according to Lugano classification of malignant lymphoma (ie, sites with ≥50% DLBCL patients with treatment response according to Lugano classification)
6. Have DLBCL treatment response assessed according to Lugano classification of malignant lymphoma or are deceased prior to opportunity for assessment
Key Exclusion Criteria:
1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS non-Hodgkin's lymphoma (NHL) on or prior to index date
2. History of allo-stem cell transplant (SCT) prior to index date
3. Treatment with any chimeric antigen receptor T (CAR-T) therapy prior to index date
4. Received anti-CD20 x anti-CD3 bispecific therapy prior to index date
5. History of neurodegenerative condition or CNS movement disorder on or prior to index date
6. Evidence of significant cardiovascular disease on or prior to index date
7. Evidence of significant pulmonary disease, defined as obstructive pulmonary disease and a history of symptomatic bronchospasm on or prior to index date
8. Eastern Cooperative Oncology Group (ECOG) performance status \>1 on or prior to index date
9. Inadequate organ function as defined in the protocol
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05338892
Study Brief:
Protocol Section:
NCT05338892