OncoMatch/Clinical Trials/NCT07254754
Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma
Is NCT07254754 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Axicabtagene Ciloleucel for diffuse large b-cell lymphoma.
Treatment: Axicabtagene Ciloleucel — Single-arm, open-label, multicenter, phase II trial aiming to include approximately 45 patients over 24 months. Patients will receive axicabtagene ciloleucel infusion and will be followed up to 5 years. The total duration of the study is therefore of 7 years.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-CD20 monoclonal antibody (rituximab, obinutuzumab) — first-line
An anti-CD20 monoclonal antibody (rituximab or obinutuzumab)
Must have received: cytotoxic chemotherapy (CHOP, ACVBP, EPOCH, COPADEM) — first-line
CHOP or CHOP-like chemotherapy Note: CHOP-like chemotherapy corresponds to ACVBP, EPOCH, or COPADEM. Dose-reduced CHOP (i.e., miniCHOP) is excluded except for dose-reductions of vincristine due to peripheral neuropathy.
Cannot have received: CD19 targeted therapy
Prior CD19 targeted therapy
Cannot have received: cytotoxic chemotherapy
Exception: more than one prior line of systemic therapy
Patients who received more than one prior line of systemic therapy
Lab requirements
Blood counts
ANC ≥ 1 x 10^9/L; Platelets ≥ 75 x 10^9/L; Absolute lymphocyte count ≥ 0.1 x 10^9/L
Kidney function
Creatinine clearance (CrCl) as estimated by Cockcroft Gault or MDRD ≥ 40 mL/min
Liver function
ALT/AST ≤ 2.5xULN; Total bilirubin <1.5 mg/dL, except in patients with Gilbert's syndrome
Cardiac function
Cardiac ejection fraction ≥ 45%
ANC ≥ 1 x 10^9/L; Platelets ≥ 75 x 10^9/L; Absolute lymphocyte count ≥ 0.1 x 10^9/L; Creatinine clearance (CrCl) as estimated by Cockcroft Gault or MDRD ≥ 40 mL/min; ALT/AST ≤ 2.5xULN; Total bilirubin <1.5 mg/dL, except in patients with Gilbert's syndrome; Cardiac ejection fraction ≥ 45%; Baseline oxygen saturation ≥ 92% on room air
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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