842 | MYHODGKIN MYHEALTH SURVIVORSHIP APP RECRUITMENT SUGGESTS HIGH ACCEPTABILITY OF PATIENT‐DERIVED DATA IN HODGKIN LYMPHOMA

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Introduction: In the ZUMA-7 trial, axicabtagene ciloleucel (axi-cel) demonstrated superior efficacy compared to salvage chemotherapy plus autologous stem-cell transplantation (ASCT) for patients with primary refractory or early relapsed large B cell lymphoma (LBCL), leading to the consideration of axi-cel as the new standard of care for this setting.However, no data is available on the efficacy of axi-cel in second line for patients relapsing more than one year after completion of first-line therapy.Although it is generally assumed that the outcome of these patients is better, studies show progression-free survival (PFS) rates around 50% with ASCT-based strategies.The LATE-R trial (EUCT: 2024-512835-53-00) studies the possible role of axi-cel in patients with late relapse LBCL.Methods: LATE-R is a phase 2, open-label, single-arm trial of axi-cel in adult patients with histologically confirmed diffuse LBCL, transformed follicular lymphoma (FL), grade 3B FL and high-grade B cell lymphoma, who relapsed between 1 and 5 years after 1st line treatment (that must include anti-CD20 and anthracyclines).HIV infection is allowed with a CD4 count > 200 cells/uL and undetectable viral load by PCR.Full eligibility criteria are available on EUCT (euclinicaltrials.eu)Study design: (1) Enrollment and leukapheresis within 5 days after eligibility confirmation; (2) optional bridging therapy, as specified in the protocol; (3) conditioning chemotherapy with fludarabine and cyclophosphamide at standard doses on day -5 to day -3; (4) a single infusion of axi-cel, administered intravenously at day 0; (5) patients will be followed for safety and efficacy endpoints from infusion up to 5 years.The primary endpoint is the complete metabolic response (cMR) at 3 months from axi-cel infusion as assessed by investigator according to Lugano Classification.Secondary endpoints are grouped in efficacy endpoints (responses rates, duration of response and survival), safety endpoints (specially focused on adverse events of special interest such as cytokine release syndrome and neurotoxicity), quality of life endpoints (patient reported outcomes), and exploratory endpoints (imaging and biological studies).Immune response markers in peripheral blood, such as cytokines and CAR-T cells, will be assessed at prespecified timepoints for associations with clinical outcomes.Figure 1 summarizes the trial design.This trial is a collaboration sponsored by the Spanish lymphoma group, GELTAMO, and Kite, a Gilead company.It involves 15 Spanish centres and aims to include 45 patients in 24 months.Enrolment began in December 2024.

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