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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT05328102
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of DLBCL, not otherwise specified, including DLBCL arising from low grade lymphoma
* CD20+ and CD19+ lymphoma
* Archival paraffin embedded tumor tissue or unstained slides must be available for retrospective cell of origin determination
* Relapsed or refractory
* At least 1 prior systemic line(s) of therapy, one of which must have included multi-agent chemoimmunotherapy that includes an anti-CD20 monoclonal antibody.
* At least 1 bidimensionally measurable disease site. The lesion must have a greatest transverse diameter of ≥ 1.5 centimeter (cm) and greatest perpendicular diameter of ≥ 1.0 cm at baseline. The lesion must have a positive finding on positron emission tomography (PET) scan
* Ineligible for or refuse hematopoietic stem cell transplantation (HSCT).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Completed vaccination for the SARS-CoV-2 virus prior to study entry
* Fertile participants must agree to use 2 highly effective methods of birth control during for at least 6 months (male participants) and 8 months (female participants) after the last dose of study treatment
Exclusion Criteria:
* Any other histological type of lymphoma, including high-grade B-cell lymphoma, including those with myelocytomatosis oncogene (MYC) and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements primary mediastinal (thymic) large B cell (PMBL) or Burkitt lymphoma
* A prior diagnosis of chronic lymphocytic leukemia (CLL) (Richter's Transformation)
* Primary central nervous system lymphoma
Exclusionary Previous and Current Treatment:
* Previously received treatment with an anti-CD20 × anti-CD3 bispecific antibody (bsAb)
* Anti-CD20 therapy (for example, rituximab) within 21 days prior to study entry
* Participants who have, within 14 days prior study entry:
* Chemotherapy, radiotherapy, or other lymphoma-specific therapy not including anti CD20 therapy
* Small molecule or investigational anticancer agents within 6 elimination half-lives
* Received live vaccines within 30 days
* Required systemic anti-infective therapy for active, intercurrent infections
* Participants who have had the following prior therapies or treatments:
* Were previously treated with CD19-targeted therapy, including chimeric antigen receptor-T cell (CAR-T), unless current biopsy is CD19+
* Have a history of hypersensitivity to compounds of similar biological or chemical composition to tafasitamab, immunomodulatory imide drugs (IMiDs)
* Previous allogenic stem cell transplantation
* Have a history of deep venous thrombosis/embolism, threatening thromboembolism
* Concurrently use other anticancer or experimental treatments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05328102
Study Brief:
Protocol Section:
NCT05328102