๐ฌIn plain words
What the trial is, and whether it could suit you
This is a prospective, single-arm, single-center, open-label clinical study, aiming to evaluate the efficacy and safety of CAR-T combined with ASCT in the treatment of relapsed/refractory large B-cell lymphoma with high-risk factors.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Age โฅ 18 years
2. Histopathologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), central nervous system lymphoma (CNSL), primary mediastinal large B-cell lymphoma (PMBCL), and transformed follicular lymphoma (tFL)
3. Must have received first-line treatment with a regimen containing anti-CD20 monoclonal antibody and anthracycline
4. Meet one of the following clinical high-risk factors or molecular biological high-risk factors:
1. Clinical high-risk factors: Failure to achieve partial response (PR) after 4 cycles of first-line immunochemotherapy; or relapse within 12 months after achieving complete response (CR) with first-line immunochemotherapy; or relapse after autologous hematopoietic stem cell transplantation (ASCT); or central nervous system involvement at the time of disease relapse or progression
2. Molecular biological high-risk factors: TP53 gene mutation; or high-grade B-cell lymphoma (HGBL) with MYC and Bcl-2 rearrangements, with or without Bcl-6 rearrangement
5. ECOG 0 to 2
6. Eligible for high-dose chemotherapy/autologous hematopoietic stem cell transplantation (HDCT/ASCT) per the investigator's assessment, and planned to receive a sequential regimen of ASCT followed by CAR-T therapy
7. Hepatic and renal function meet the following criteria: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) โค 3 ร upper limit of normal (ULN); total bilirubin โค 1.5 mg/dL; serum creatinine โค 1.5 ร ULN, or creatinine clearance (calculated using the Cockcroft-Gault formula) โฅ 30 mL/min
8. Left ventricular ejection fraction (LVEF) โฅ 40%
9. Life expectancy โฅ 3 months
Exclusion Criteria:
1. Patients who have previously received any CD19-targeted therapy
2. Patients with CD19 negativity confirmed by immunohistochemistry (IHC)
3. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBV DNA or HCV RNA level above the upper limit of normal (ULN), with or without liver function abnormalities
4. Presence of uncontrolled infection, cardio-cerebrovascular diseases, coagulopathy, or connective tissue diseases
5. History of human immunodeficiency virus (HIV) infection
6. Pregnant or lactating patients
Zhejiang Cancer Hospital
Hangzhou, China
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.