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 @ 9:33 PM
Ignite Modification Date:
2025-12-24 @ 9:33 PM
NCT ID:
NCT06996132
Eligibility Criteria:
Inclusion Criteria:
1. Patients with relapsed/refractory aggressive B-cell lymphoma, including the following subtypes: diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), or transformed large B-cell lymphoma.
2. Relapsed or refractory disease, meeting criteria for one of the following cohorts:
Cohort 1 (Relapsed/Refractory Disease):
1. ≥2 prior lines of therapy (including both anti-CD20 monoclonal antibody and anthracycline-based chemotherapy) with documented progression following last treatment; OR
2. Failure of first-line immunochemotherapy (containing anti-CD20 antibody and anthracycline) defined by any of:
* Relapse/progression within 12 months of treatment completion; OR
* Progressive disease during first-line therapy; OR
* Stable disease as best response after 4 cycles; OR
* Partial response as best response after 6 cycles.
Cohort 2 (Early Treatment Failure):
* Persistent metabolic activity (Deauville 5) on PET-CT after 2 cycles of first-line immunochemotherapy; OR
* Biopsy-proven residual disease following initial therapy.
3. Age ≥18 years and ≤65 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
5. Hematologic parameters at screening must meet the following (unless due to bone marrow involvement):
* Absolute neutrophil count (ANC) ≥1×10⁹/L,
* Platelet count (PLT) ≥75×10⁹/L.
6. Biochemical parameters at screening must meet the following:
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN);
* Total bilirubin (TBIL) ≤1.5×ULN (unless due to Gilbert's syndrome or non-hepatic causes);
* Serum creatinine (Cr) ≤2×ULN OR creatinine clearance ≥40 mL/min.
7. Left ventricular ejection fraction (LVEF) within institutional normal range by echocardiography.
8. Baseline oxygen saturation \>92% on room air.
9. Life expectancy ≥3 months as assessed by the investigator.
Exclusion Criteria:
1. Confirmed primary central nervous system lymphoma;
2. Prior autologous or allogeneic hematopoietic stem cell transplantation;
3. Active HBV or HCV infection, defined as HBV-DNA or HCV-RNA levels above the upper limit of detection.
4. Uncontrolled comorbidities include infectious diseases, cardiovascular/cerebrovascular disorders, coagulopathies, and connective tissue diseases.
5. History of epilepsy or other central nervous system disorders;
6. Pregnancy or lactation;
7. HIV infection;
8. History of other malignancies unless:
1. Disease-free for ≥5 years, or
2. Previously cured of the following:
* Non-melanoma skin cancers (basal cell carcinoma, squamous cell carcinoma, or related localized cutaneous malignancies)
* Carcinoma in situ of cervix
9. Other conditions deemed ineligible by investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06996132
Study Brief:
Protocol Section:
NCT06996132