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 (Jun 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
Treatments studied
Immunotherapy
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.
Frequently asked questions
Is NCT07254754 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CD19 targeted therapy, cytotoxic chemotherapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify