Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection as First-Line Ther… (NCT06935136) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection as First-Line Therapy of High-Risk Large B-Cell Lymphoma
China60 participantsStarted 2025-04-30
Plain-language summary
The goal of this is Single-Arm, Multicenter, Open-Label Clinical Study is to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection(Axi-cel) as First-Line Therapy of High-Risk Large B-Cell Lymphoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed LBCL (Large B-Cell Lymphoma) according to the WHO 2016 classification, including the following subtypes:DLBCL-NOS (Diffuse Large B-Cell Lymphoma, Not Otherwise Specified),HGBL (High-Grade B-Cell Lymphoma, including HGBL with MYC, BCL-2, and/or BCL-6 rearrangements (DHL/THL), HGBL-NOS),DLBCL transformed from follicular or marginal zone lymphoma, eligible if the patient has not previously received anthracycline-containing therapy
* International Prognostic Index (IPI) score of 2-5 at initial diagnosis.
* Individuals must have a positive interim positron emission tomography (PET) (Deauville PET score of 4 or 5) after 2 cycles (PET2+) of chemoimmunotherapy or high-risk ctDNA status (ctDNA levels not reduced by at least 2-log after two cycles of R-chemotherapy)
* Age of 18 years or older.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
* Adequate renal, hepatic, pulmonary, and cardiac function, defined as:
* Creatinine clearance (estimated by Cockcroft-Gault formula) ≥ 60 mL/min
* Serum ALT/AST ≤ 2.5 × Upper Limit of Normal (ULN)
* Total bilirubin ≤ 1.5 × ULN (except for patients with Gilbert's syndrome)
* Left ventricular ejection fraction ≥ 50%, no pericardial effusion as determined by echocardiography, and no clinically significant arrhythmias No clinically significant pleural effusion
* Baseline peripheral oxygen saturation \> 92% under room air ventilation
* At least one measurable lesio…
What they're measuring
1
Complete Response (CR) Rate Per the Lugano Classification as Determined by Study Investigators