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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07335120
Eligibility Criteria:
Inclusion Criteria:
* Males and female subjects ≥16 years of age at the time of enrolment.
* Ability to understand and sign written informed consent.
* Previously untreated histologically proven Large B-cell non-Hodgkin's lymphoma (LBCL) according to the current World Health Organisation 2016 classification including all morphological variants.
Cohort A:
* Large B-cell lymphomas i) Diffuse large B-cell lymphoma, NOS ii) T-cell/histiocyte-rich large B-cell lymphoma iii) Diffuse large B-cell lymphoma/ high grade B-cell lymphoma with MYC and BCL2 re-arrangements. iv) High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements v) ALK-positive large B-cell lymphoma vi) Large B-cell lymphoma with IRF4 rearrangement vii) High-grade B-cell lymphoma with 11q aberrations or Burkitt-like lymphoma with 11q aberration viii) EBV-positive diffuse large B-cell lymphoma EBV-positive diffuse large B-cell lymphoma, NOS ix) Diffuse large B-cell lymphoma associated with chronic inflammation x) Fibrin-associated large B-cell lymphoma xi) Plasmablastic lymphoma xii) Primary large B-cell lymphoma of immune-privileged sites (vitro-retinal and testis but not CNS) and Intravascular large B-cell lymphoma xiii) Primary mediastinal large B-cell lymphoma xiv) Mediastinal grey zone lymphoma B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classic Hodgkin lymphoma xv) High-grade B-cell lymphoma, NOS xvi) HIV or KSHV/HHV8-positive diffuse large B-cell lymphoma
* De novo presentations of transformed indolent B-cell lymphomas.
* LBCL patients with de novo disease unfit for full dose R-CHOP/Pola-R-CHP OR
Cohort B:
* LBCL patients (as in Cohort A) with relapsed/refractory disease (including de novo transformed indolent B-cell lymphomas) following frontline (one previous line of chemo-immunotherapy) including any line CAR-T therapy.
* Patients fulfilling the above criteria who are on other trials/studies are eligible for recruitment.
* Patients previously registered into Cohort A with subsequent relapsed/refractory disease. Such patients can be registered into cohort B and will be given a new study number that is linked to their study number for cohort A.
* Data for patients commencing treatment \<6 months prior to enrolment and with ongoing follow-up can be entered retrospectively.
Exclusion Criteria:
1. Patients treated \>6 months prior to trial enrolment (Cohort B).
2. Patients eligible for full dose R-CHOP/Pola-R-CHP (Cohort A)
3. Patients with CNS lymphoma
4. Lymphoid proliferations and lymphomas associated with immune suppression and dysregulation. (e.g., Post-Transplant Lymphoproliferative Disorders)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Study:
NCT07335120
Study Brief:
Protocol Section:
NCT07335120