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 @ 4:22 PM
Ignite Modification Date:
2025-12-24 @ 4:22 PM
NCT ID:
NCT03340766
Eligibility Criteria:
Inclusion Criteria:
* Have histologically confirmed diffuse large B-cell lymphoma that is either:
* Refractory after at least one regimen of systemic chemotherapy and/or targeted therapy, or
* In first or later relapse if have received at least 2 systemic regimens since time of diagnosis, or
* Relapsed post-autologous or allogeneic hematopoietic stem cell transplantation (HSCT) with adequate organ function after proximity to transplantation time exclusions
* Have measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Life expectancy of ≥ 12 weeks in the opinion of the Investigator
* Biopsy proven DLBCL (biopsy proven at least at primary diagnosis of DLBCL)
Other Inclusion Criteria May Apply
Exclusion Criteria:
* Richter's transformation (DLBCL arising in the setting of prior chronic lymphocytic leukemia) or primary mediastinal B cell lymphoma (PMBCL)
* History or presence of clinically relevant central nervous system pathology such as epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
* Has a diagnosis of immunodeficiency or has received systemic steroid therapy (in excess of 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of protocol specified therapy.
* Has undergone prior allogeneic HSCT:
* within the last 5 years OR
* greater than 5 years ago but has active graft versus host disease (GvHD) requiring systemic treatment.
* Has received autologous HSCT within 6 weeks prior to start of treatment.
Other Exclusion Criteria May Apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03340766
Study Brief:
Protocol Section:
NCT03340766