Not yet recruiting NCT06935136
Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection as First-Line Therapy of High-Risk Large B-Cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Axicabtagene Ciloleucel.
- Who it may be relevant to
- Registry conditions: CAR-T Cell Therapy, High-risk Large B-cell Lymphoma (LBCL). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Arm, Multicenter, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection as First-Line Therapy of High-Risk Large B-Cell Lymphoma
Overview
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.
Interventions
- Drug Axicabtagene Ciloleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Primary outcome measures
- Complete Response (CR) Rate Per the Lugano Classification as Determined by Study Investigators [Time frame: Up to 2 years]
Secondary outcome measures (6)
- Objective Response Rate (ORR) Per the Lugano Classification as Determined by Study Investigators [Time frame: Up to 2 years]
- Complete Metabolic Response (CMR) - determined by investigator [Time frame: 3 months from axi-cel infusion]
- Duration of Response (DOR) Per the Lugano Classification [Time frame: Up to 2 years]
- Progression-Free Survival (PFS) [Time frame: Up to 2 years]
- Overall Survival (OS) [Time frame: Up to 2 years]
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAE) [Time frame: Up to 2 years]
Eligibility criteria
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 lesion.
- For women of childbearing potential, a negative serum pregnancy test is required (women who have undergone surgical sterilization or are postmenopausal for at least 2 years are considered not to be of childbearing potential).
Exclusion criteria
- According to the WHO 2016 classification, patients with the following subtypes are excluded:
- LBCL with T-cell/histiocyte-rich background
- Primary central nervous system DLBCL
- PMBCL (Primary Mediastinal B-Cell Lymphoma)
- B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical HL (Hodgkin Lymphoma)
- Burkitt lymphoma
- History of Richter transformation in chronic lymphocytic leukemia
- Presence of detectable malignant cells in the CSF (cerebrospinal fluid), brain metastases, or history of central nervous system involvement by lymphoma.
Presence of cardiac involvement by lymphoma.
- Prior treatment for LBCL other than two cycles of R-chemotherapy.
- History of severe immediate hypersensitivity reaction to any of the drugs used in this study.
- Presence of central nervous system disorders: history of stroke, transient ischemic attack, or reversible posterior leukoencephalopathy syndrome (PRES) within 12 months prior to enrollment.
- History of acute or chronic active hepatitis B or C infection, unless HBV-DNA and HCV-RNA levels are below the level of detection.
- Human immunodeficiency virus (HIV) positivity, unless on appropriate antiretroviral therapy with undetectable viral load by PCR and a CD4 count > 200 cells/µL.
- Any medical condition that may interfere with the assessment of the safety or efficacy of the study treatment.
- History of clinically significant cardiac disease within 12 months prior to enrollment.
- Any other condition deemed by the investigator as unsuitable for enrollment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- China — Shanghai
Identifiers
NCT: NCT06935136 · RJ-1L HR-01