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CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.

RecruitingPhase 2Ages 18 Years - anyAllZhejiang Cancer Hospital
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In 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.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ 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) โ‰ค 3 ร— upper limit of normal (ULN); total bilirubin โ‰ค 1.5 mg/dL; serum creatinine โ‰ค 1.5 ร— ULN, or creatinine clearance (calculated using the Cockcroft-Gault formula) โ‰ฅ 30 mL/min 8. Left ventricular ejection fraction (LVEF) โ‰ฅ 40% 9. Life expectancy โ‰ฅ 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
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What it tests

  • Axicabtagene Ciloleucel
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Where

1 site
Zhejiang Cancer Hospital
Hangzhou, China
๐Ÿค 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.
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