INTRODUCTION:Anti-CD38 monoclonal antibodies (aCD38) are increasingly used in early lines of therapies in multiple myeloma (MM). Retreatment with aCD38-based regimen is a widely used practice in later lines. However, data coming from clinical trials are currently limited. EMMY is a noninterventional, prospective dynamic cohort study conducted in 73 centers in France to assess the real-life management of MM in France and which can explore the efficacy of aCD38-based retreatment. METHODS:Patients who initiated a second line of treatment with aCD38-based combinations after a first exposure to aCD38 were identified and described and the outcomes of progression-free survival (PFS) and overall survival (OS) were estimated. RESULTS:In the EMMY cohort, 286 patients received 2 lines of treatment including aCD38. For all aCD38-retreated patients, median PFS was estimated at 5.1 months. Median PFS was 23.6 m in patients sensitive to aCD38 and 4.6 in nonsensitive patients, P = .0003. Median OS was estimated at 17.3 months for all patients,14.8 months in patients nonsensitive to aCD38, and not reached (NR) in sensitive patients, P = .0004. No significant differences in PFS or OS were observed between the refractory and nonrefractory to aCD38 groups. CONCLUSION:These results of aCD38 retreatment in a large sample of real-life patients (n = 286) in extensively pretreated patients show that retreatment may be a meaningful strategy for aCD38 sensitive patients. These findings need to be investigated further while the use of aCD38 is emerging as a first-line treatment for newly diagnosed patients.

Introduction Elranatamab (ELRA) is a humanized, bispecific antibody that targets both B-cell maturation antigen (BCMA) on multiple myeloma (MM) cells and CD3 on T cells, with the aim of inducing T cell–mediated cytolysis of the MM cells. ELRA was approved in the US and EU in 2023 as monotherapy for the treatment of triple-class exposed relapsed-refractory MM based on the phase II MagnetisMM-3 (NCT04649359) registrational study. ELRA started with 2 step-up priming doses (SUD): 12 mg on day 1 and 32 mg on day 4 of cycle 1 followed by the initial 76 mg dose. The aim here is to report ELRA SUD patterns and related CRS and ICANS in the real-world settings. Methods AMbreLA (EUPAS1000000074) is an observational ambispective study to evaluate the effectiveness and safety of ELRA in the real-world setting in adult patients who initiated ELRA in France from May 2023 to September 2025, as part of the early access program. Only retrospective and ambispective patients (no prospective-only patients) were selected for this first interim analysis to ensure a longer follow-up period. Adverse events (AEs) occurring prior to patient inclusion are collected only if they are related to a Pfizer product, while AEs occurring after inclusion are collected regardless of whether they are related to a Pfizer product. The results presented here are part of the first interim analysis with a data cut-off of February 28, 2025, and will be updated with data cut-off planned on July 31, 2025. We descriptively analyzed patient and disease characteristics, prior line(s) of therapy, SUD patterns, incidence of CRS and ICANS and overall response rate (ORR). Results These results will be updated for the poster presentation to include approximately 80 patients from 31 medical centers A total of 28 patients from 13 centers who received ELRA between June 29, 2023, and December 23, 2024, were included in this analysis. The median (95% CI) follow-up was 9.9 (6.1-13.9) months. Median (Q1-Q3) age was 71.5 (66.5-74.5) years; 25% were aged ≥75 years. 57.1% were male. Median time from first MM diagnosis to ELRA initiation was 9.2 (4.6-12.3) years. 60.7% of patients had at least one comorbidity at ELRA initiation, 35.7% had hypertension, 21.4% had renal impairment/failure, and 10.7% had peripheral neuropathy. 37.5% of patients had an ECOG-PS ≥2 and 68.4% had an ISS of II or III. 35.7% had extramedullary disease and, among patients with genetic screening available (n=17/28), 3 (17.6 %) harbored del(17p). Patients received a median of 5 (range, 2-12) prior lines of therapy. 96.4% were triple-class exposed, 67.9% were penta-class exposed, and 6 (21.4%) had received prior BCMA-directed therapy, of whom 5 had received CAR-T cell therapy and 1 had received both an antibody-drug conjugate and a BCMA bispecific. 23.3% of the patients received ELRA in out-patient hospitalization setting, during or after the SUD schedule, the others were treated in conventional hospitalization. All patients completed SUD schedule except for 1 who progressed after the second dose. Median time from SUD 1 to 2, 2 to 3 and 1 to 3 was 3.0 (3.0-4.0), 4.0 (3.0-4.5) and 7.0 (7.0-8.0) days, respectively. 67.9% of patients started the full dose (76 mg) on or before day 8. 28 (100%) patients received per-label recommended pre-medication. CRS was observed in 46.4% of patients, and no serious CRS was reported, whereas 2 ICANS were reported in 1 patient (including 1 SAE). CRS occurred after doses 1 (71.4%), 2 (21.4%), and 3 (7.1%). Recurrent CRS and ICANS occurred in 1 patient. Median time to onset of CRS and ICANS was 3.0 (2.0-3.8) and 11.5 (6.8-16.2) days, respectively. Median time to resolution of CRS and ICANS was 2.5 (2.0-4.0) and 8.0 (8.0-8.0) days, respectively. No patient permanently discontinued ELRA treatment due to CRS or ICANS. Overall, 21 (75%) patients experienced at least 1 AE including 6 (21.4%) who had at least 1 SAE. 5 (17.9%) patients had an AE leading to treatment discontinuation. ORR was reached by 17 patients. VGPR or better was achieved by 16 patients. Median time to VGPR or better was 1.9 (0.9-4.2) months. Conclusions These preliminary results of the AMbreLA study provide an accurate picture of real-world SUD patterns. It confirms that the adapted ELRA SUD schedule and per-label recommended premedication is associated with good management of CRS and ICANS. More patients with longer follow-up are needed to update these data, as real-world profiles and treatment patterns may evolve over time.

Taking into account higher risk of severe coronavirus disease 2019 or death among patients with cancer, as well as impaired immunogenicity after anti-SARS-CoV-2 vaccines, in addition to waning immunity, booster dosing appears mandatory in this patient population. This review sought to provide reasonable evidence so as to assist oncologists in their daily practice, helping them decide when an anti-SARS-Cov2 antibody (Ab) dosage should be scheduled after a full two-dose vaccination and, if necessary, propose an early third dose (D3). Such D3 could apply to non-responder patients with anti-Spike (S) Abs titres <40 binding Ab unit (BAU)/mL. For lowresponder patients with anti-S Ab titres between 40 BAU/mL and 100/260 BAU/mL (suggested area of uncertainty), an early D3 may similarly be proposed. Nevertheless, this D3 could be administered in a less urgent manner, taking into account associated comorbidities and regional epidemic incidence rates. This latter strategy may comprise a monthly dosage of anti-S titres so as to better assess the kinetics of waning immunity. For responder patients with anti-S titres above 260 BAU/mL, we suggest to follow the recommendations outlined for the general population. Given this context, patients with anti-S titres above 1000 BAU/mL should be given the possibility to undergo anti-S titre control after three months, designed to assess rapid humoral waning immunity. We strongly recommend that patients with cancer be included into observational serological monitoring studies or clinical trials that are dedicated to severe immunocompromised patients without any humoral seroconversion after D3.

Patients with hematological malignancies have impaired immune response after two doses of BNT162b2 (Pfizer/BioNTech) vaccine against SARS-CoV-2. Here, in this observational study (registration number HDH F20210324145532), we measure SARS-CoV-2 anti-Spike antibodies, neutralizing antibodies and T-cell responses after immune stimulation with a third dose (D3) of the same vaccine in patients with chronic lymphocytic leukemia ( n = 13), B cell non-Hodgkin lymphoma ( n = 14), and multiple myeloma ( n = 16)). No unexpected novel side effects are reported. Among 25 patients with positive anti-S titers before D3, 23 (92%) patients increase their anti-S and neutralizing antibody titer after D3. All 18 (42%) initially seronegative patients remain negative. D3 increases the median IFN-γ secretion in the whole cohort and induces IFN-γ secretion in a fraction of seronegative patients. Our data thus support the use of a third vaccine dose amongst patients with lymphoid malignancies, even though some of them will still have vaccine failure.

A higher risk of death from coronavirus disease 19 has been shown for patients with solid cancers or haematological malignancies (HM). Thanks to the accelerated development of anti-SARS-SoV-2 vaccines in less than a year since the start of the global pandemic, patients with cancer were quickly prioritised in early 2021 for vaccination, however dependent on the very unequal availability at the global level. Impaired immunogenicity of SARS-CoV-2 mRNA vaccines in immunocompromised patients was rapidly reported as early as April 2021, although the vaccination fortunately appears to be generally effective without increasing the spacing. Worryingly, the humoral response of the SARS-CoV-2 vaccination is, however, considered insufficient in patients followed for HM, in particular when they are on anti-CD20 treatment. Thus, improving vaccination coverage by strengthening immune stimulation should be evaluated in patients under active treatment against cancer. Here, we discuss three different approaches: a third dose of early vaccine (repeated immune stimulation), heterologous prime-boost vaccination (multimodal immune stimulation) and a double-dose strategy (maximisation of immune response). Dedicated therapeutic trials, currently almost non-existent, seem rapidly necessary.

BACKGROUND: Immunocompromised patients such as patients with hematological malignancies have impaired immune response to two doses of BNT162b2 (Pfizer / BioNtech) vaccine against SARS-CoV-2. Evaluation of a repeated immune stimulation with a third vaccine dose is needed. METHODS: a vaccine monitoring observatory was conducted in outpatients who were treated for lymphoid malignancies (LM) to monitor both immune and cellular response measured the day of administration of the dose 3 of the mRNA vaccine BNT162b2 and again three to four weeks. Elecsys ® Anti-SARS-CoV-2 immunoassay was used to asses to the level of SARS-CoV-2 anti-Spike (S) antibodies (Abs) titer and SARS-CoV-2-specific T-cell responses were assessed by a whole blood Interferon-Gamma Release Immuno Assay (IGRA) (QuantiFERON Human IFN-gamma SARS-CoV-2, Qiagen®). RESULTS: Among the 43 assessable patients (suffering from chronic lymphocytic leukemia (CLL) (n=15), indolent and aggressive B cell non-Hodgkin lymphoma (NHL) (n=14), and multiple myeloma (MM) (n=16)), 18 (41,8%) had no anti-S Abs before the dose 3 of BNT162b2 vaccine (n=9 CLL, n=8 NHL, n=1 MM), and they all 18 remained negative after the dose 3. Amongst the 25 patients with positive anti-S titers before dose 3, all patients remained positive and 23 patients increased their anti-S titer after dose 3. Patients with CLL and/or with previous anti-CD20 therapy treated within 12 months of administration of dose 3 had no significant increase of the humoral response. Among 22 available patients, dose 3 of BNT162b2 vaccine significantly increased the median IFN-gamma secretion. On eight (36.4%) patients who were double-negative for both immune and cellular response, five (22.7%) patients remained double-negative after dose 3. CONCLUSIONS Dose 3 of BNT162b2 vaccine stimulated humoral immune response among patients with LM, in particular patients with MM (who had higher anti-S baseline titer after dose 2) and those with no anti-CD20 treatment history within a year. T-cell response was increased among patients in particular with no active chemotherapy regimen. Our data support the use of an early third vaccine dose among immunocompromised patients followed for LM though some of them will still have vaccine failure.

Daniel Re , J erôme Barri ere , Emmanuel Chamorey , Margaux Delforge, Lauris Gastaud, Emmanuel Petit, Axel Chaminade, Benjamin Verri ere and Fr ed eric Peyrade Department of Medical Oncology, Centre Hospitalier Antibes Juan-les-Pins, Antibes, France; Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France; Department of Medical Oncology, Clinique Saint-Jean, Cagnes-sur-Mer, France; Department of Biostatistics and Epidemiology, Centre Antoine Lacassagne, Nice, France; Department of Pharmacy, Centre Hospitalier Antibes Juan-les-Pins, Antibes, France

Median age at diagnosis of chronic lymphocytic leukemia is 72 years. However, only few patients over 80 years of age are included in clinical trials, even in those devoted to unfit patients. In order to evaluate both efficiency and safety of venetoclax in this category of patients, we conducted a multicentric retrospective study and collected data from 77 CLL patients from 19 FILO centers who started venetoclax after 80 years of age.

Among patients with SARS-CoV-2 infection (also known as COVID-19), pneumonia, respiratory failure and acute respiratory distress syndrome are frequently encountered complications.1 Although the pathophysiology underlying severe COVID-19 remains poorly understood, accumulating evidence argues for hyperinflammatory syndrome causing fulminant and fatal cytokines release associated with disease severity and poor outcome.2 However, the spectrum of complications is broader and includes among others various auto-immune disorders such as autoimmune thrombocytopenia, Guillain–Barré and antiphospholipid syndrome.3-5 In this report we describe seven patients from six French and Belgian Hospitals who developed a first episode of autoimmune haemolytic anaemia (AIHA) during a COVID-19 infection. Patient characteristics are detailed in Table I. Briefly, median age was 62 years (range, 61–89 years), and all patients presented with risk factors for developing a severe form of COVID-19 such as hypertension, diabetes and chronic renal failure. All patients had both a positive oropharyngeal swab for SARS-CoV-2 and typical images of COVID-19 infection on chest computed tomography scans (25–75% extension). Three patients were admitted in an intensive care unit but only one required invasive ventilation. Treatment for COVID-19 infection differed according to the standards of each centre. Thus, three patients received hydroxychloroquine, in association with azithromycin for two of them, and one patient received lopinavir and ritonavir. 1. Steroids 2. Rituximab PR Planed 1. Steroids 2. Rituximab‡ Failure Ongoing The median time between the first COVID-19 symptoms and AIHA onset was nine days (range 4–13 days), and haemoglobin level decreased by more than 30 g/l in all cases. Median haemoglobin level at the time of AIHA diagnosis was 70 g/l (range 3·8–10·8), and all patients presented with marked haemolysis signs. Direct antiglobulin test (DAT) was positive in all cases either for IgG (n = 2), for C3d (n = 2), or for both IgG and C3d (n = 3). Anti-erythrocyte antibodies were warm antibodies in four cases (two of IgG specificity and two IgG + C3d) and cold agglutinins in three cases (two of C3d specificity and one IgG + C3d). At the time of AIHA onset, all patients had elevated markers of inflammation (i.e. fibrinogen, D-dimers and C-reactive protein). Interestingly, among the patients with warm antibodies, two patients were known for stable untreated Binet stage A chronic lymphocytic leukaemia (CLL); an IgG kappa monoclonal gammopathy of undetermined significance was demonstrated in a third one. In 2/3 patients with cold agglutinin, systematic lymphocyte immunophenotyping demonstrated the presence of a monotypic B lymphoid population with a phenotype compatible with marginal zone lymphoma (MZL). The third one was diagnosed with prostate cancer. AIHA management included corticosteroids for five patients, and red blood cells infusions for two. Even if the follow-up is still short, three patients receiving corticosteroids were evaluable for response of AIHA. Two patients reached partial response defined by haemoglobin level >100 g/l along with an increase of 20 g/l at least seven days after an infusion with red blood cells. Corticosteroid failure lead to rituximab injection in the third case (patient #6), and one responding patient is scheduled to receive rituximab because of a MZL clone (patient #3). At the time of last follow-up, all patients were alive and had at least partly recovered from COVID-19. To conclude, we report seven cases of warm and cold AIHA associated with COVID-19 disease, all of them occurring after the beginning of the symptoms of the infection and within a timeframe compatible with that of the cytokine storm. Four out of the seven patients had indolent B lymphoid malignancy either already known or discovered because of the haemolytic episode. AIHA is a classical complication of both CLL and MZL,6, 7 and viral infections are known to trigger autoimmune cytopenias.8 Whether the presence of an underlying malignant B lymphoid clone facilitated the onset of AIHA is unknown. Nonetheless, these observations argue for systematically investigating for the presence of a lymphoid clone in patients presenting with COVID-19 infections and autoimmune cytopenias. The authors thank the French Innovative Leukemia Organization (FILO) group for initiating the study. GL, AQ and FC designed the research study, analyzed the data and wrote the paper. MB, JS, CJ, DR, FM, AM, TB, GD and AD contributed to conception, patient enrollment and data collection.

Mutational analyses performed following acquired ibrutinib resistance have suggested that chronic lymphocytic leukemia (CLL) progression on ibrutinib is linked to mutations in Bruton tyrosine kinase (BTK) and/or phospholipase Cγ2 (PLCG2) genes. Mutational information for patients still on ibrutinib is limited. We report a study aimed to provide a “snapshot” of the prevalence of mutations in a real-life CLL cohort still on ibrutinib after at least 3 years of treatment. Of 204 patients who initiated ibrutinib via an early-access program at 29 French Innovative Leukemia Organization (FILO) centers, 63 (31%) were still on ibrutinib after 3 years and 57 provided a fresh blood sample. Thirty patients had a CLL clone ≥0.5 × 109/L, enabling next-generation sequencing (NGS); BTK and PLCG2 mutations were detected in 57% and 13% of the NGS samples, respectively. After median follow-up of 8.5 months from sample collection, the presence of a BTK mutation was significantly associated with subsequent CLL progression (P = .0005 vs no BTK mutation). Our findings support that mutational analysis should be considered in patients receiving ibrutinib who have residual clonal lymphocytosis, and that clinical trials are needed to evaluate whether patients with a BTK mutation may benefit from an early switch to another treatment.

e20035 Background: Rd is a treatment option for patients (pts) ineligible for transplant. Lenalidomide (R) pharmacokinetics (PK) has been evaluated in pts under 65 and very few data are available about PK, dosage safety and efficacy for pts older than 80. This retrospective study aimed to describe safety and efficacy of R in pts > 80 years. Methods: We did a retrospective study in 7 centers in France. Inclusion criteria were: pts > 80 with a MM treated with Rd. The primary outcome was Progression-Free Survival (PFS). Secondary outcome were PFS according to the dose of Rd, Overall Survival (OS), grade 3 and 4 toxicities. Results: 144 consecutive pts received Rd at a median age of 83.5 [80 ; 93.5]. Charlson score was 4 [2 ; 12]. A majority of pts (n = 103, 78%) had stage III MM (Salmon and Durie) at diagnosis and 13% (n = 16) had a clearance of creatinine < 40mL/min or/and creatinine > 173µmol/L. Median number of lines of treatment was 1 [0 ; 4]. Initial dose of R was 15mg [5 ; 25] ; 56 pts had a daily dose < 15mg and 80 ≥ 15mg. Median number of cycles of Rd was 8 [1 ; 64]. With a median follow-up of 23.2 months [1 ; 93] the 1 and 2-years PFS and OS were 72.1%/62.8% and 87.1%/78.5% respectively. At the end of follow-up 29 pts died (20%), 27 from myeloma, 0 from treatment toxicities. Complete response rate (CR), Strict CR, very good partial response, PR, stable disease and immediate progression were respectively of 8.8%, 2.2%, 20.4%, 51.8%, 9.5% and 7.3%. Rd was discontinued for progression in 63.9% of pts. 14.6% and 2.8% of pts had grade 3 or 4 toxicities respectively. 24 pts had another line of treatment after Rd. In univariate analysis, R dosage did not correlate with OS (p = 0.3), PFS (p = 0.8) or response. In multivariate analysis, the unique significant predictive factor associated with a worse OS was Hb < 10g/dL (p = 0.01). Conclusions: Rd is feasible in very old pts at a dosage of 15mg per day. Our results compare favorably with previous large prospective phase 3 study. In patients over 80, PK analysis seems to be mandatory to determine the adapted dosage.

Azacitidine is a demethylating and cytotoxic drug for the treatment of adult patients with (1) myelodysplastic syndromes, (2) chronic myelomonocytic leukemia, and (3) acute myeloid leukemia who are not eligible for induction treatment or hematopoietic stem cell transplantation. Widely described in the literature, the main adverse events are hematotoxicity, digestive toxicity, asthenia, cutaneous toxicity, and infections such as neutropenic sepsis and pneumonia. The pivotal phase III comparative and supporting studies did not point out interstitial pneumonitis as a significant adverse event. Rare clinical data from literature report interstitial lung disease secondary to azacitidine administration, which should therefore be considered as a serious potential adverse event. We, herein, report a case of an 86-year-old white woman with acute myeloid leukemia and azacitidine-induced interstitial pneumonitis.

The mean age at diagnosis of chronic lymphocytic leukemia (CLL) is 72 years, with 22.8% of patients being older than 80 years. However, the elderly are underrepresented in clinical studies of CLL. We performed a retrospective study of CLL patients aged 80 years or older at the initiation of first-line therapy in hospitals affiliated with the French intergroup on CLL (French Innovative Leukemia Organization) between 2003 and 2013. Here, we describe the clinical and biological characteristics, treatment, and outcomes for 201 patients. The median age of the cohort was 83.2 years (80-92 years). The median Cumulative Index Rating Scale comorbidity score was 5 and the median creatinine clearance was 48 mL/min (Cockcroft-Gault formula). At treatment initiation, Binet stage was A (26.4%), B (27.9%), or C (40.3%). Therapy consisted mainly of chlorambucil (65.7%), bendamustine (10.5%), and rituximab (44.3%) as follows: chlorambucil alone (45.3%) or immunochemotherapy (48.3%) with rituximab + chlorambucil (22.7%), rituximab + bendamustine (10.4%), or rituximab + cyclophosphamide + dexamethasone (5.5%). The overall response rate was 66.2% with 31.8% dinical complete remission. The median overall and progression-free survival from treatment initiation was 53.7 and 18.3 months, respectively. These results suggest that treatment is feasible in this age group. even with immunochemotherapy. Thus. prospective trials should target this population and oncogeriatric evaluation and new targeted therapies should be part of such future trials.

Background: Azacitidine (AZA) is the first line for myelodysplastic syndromes (MDS) and acute myeloid leukemia with less than 30% of blasts (Fenaux et al., Lancet Oncology 2009). This is also the treatment of AML with more than 30% of blasts uneligible for intensive chemotherapy (Dombret et al., Blood 2015). Expected response rate is around 50-60%. 50% and more than 80% of AZA responses were observed after 3 cycles and 6 cycles, respectively. Therefore, the FDA/EMEA approved schedule is 75mg/m²/day subcutaneously for seven days every 28 days for at least 6 cycles to evaluate the efficiency of the drug. Unfortunately, a proportion of patients can not achieved 3 or 6 cycles and is not evaluated. The aim of this study was to define prognostic factors predicting unachievement of 3 AZA cycles.

SummaryCentral nervous system involvement (CNSi) is a rare and poorly reported complication of chronic lymphocytic leukaemia (CLL). Establishing cause and effect between the CLL and the neurological symptoms remains challenging. We have analysed a retrospective cohort of 30 CLL patients with CNSi, documented by lymphocytic infiltration either by flow cytometry of the cerebrospinal fluid (CSF; n = 29) or CNS biopsy (n = 1). Neurological symptoms were heterogeneous. At the time of CNSi, less than half of the patients had a progressive CLL and 20 had never been treated for CLL. Initial treatment with fludarabine‐based immuno‐chemotherapy, with or without intra‐CSF therapy, led to durable response in eight out of nine untreated patients. In contrast, 50% patients receiving various prior treatments needed additional therapy within a median of 4 months (1–16). Ibrutinib led to complete response in 4/4 heavily pre‐treated patients. From CNSi, 5‐year overall survival was 72% and 48% for treatment‐naïve and previously treated patients respectively (P = 0·06); 5‐year progression‐free survival (PFS) was 43% and 0% (P = 0·125). 17p deletion was significantly associated with poor PFS (P = 0·006). CNSi may be the only sign of progression of CLL and should be considered an initiation criterion of systemic treatment. Prognosis seemed to be related to CLL characteristics rather than to CNSi itself.

Vascular adverse events have been reported with nilotinib, a tyrosine kinase inhibitor prescribed for chronic myeloid leukaemia. However, few data specify their incidence, or whether they occur in predisposed patients. Hence, we prospectively studied 30 consecutive patients to assess the frequency of such adverse reactions and determine whether the patients presenting with these adverse events bear predisposing factors. From 3 to 73 months after nilotinib initiation, 10 of the 30 patients experienced vascular events. Three patients of these 10 were devoid of any patent cardiovascular risk factor, except for age. This study points out an occurrence more frequent than expected of vascular adverse events associated with nilotinib (> 30% vs. < 1% in summary of product characteristics), and particularly of vascular events of late onset in patients with no pre‐existing risk factors.

Management of Acute Myeloid Leukemia (AML) in the elderly is particularly difficult as life expectancy is highly variable and the benefit-risk ratio of treatment depends on comorbidities and age-related pharmacological specificities.

Autologous stem cell transplant (ASCT) after high-dose chemotherapy (HDT) increases overall survival when used in relapsed non-Hodgkin lymphoma (NHL) in patients under 65 years old. Limited experience is available for older patients. We present a retrospective analysis of 73 consecutive patients aged over 65 years treated for aggressive or relapsed lymphoma by HDT with carmustine, etoposide, cytarabine and melphalan (BEAM) at full dosage followed by ASCT. Patient data were obtained from medical charts from two institutions. Median age was 67 years (65-74). Significant comorbidities were present in 24.7% of patients. The median number of days for grade 4 neutropenia was 9 (5-18). The early treatment-related mortality rate (<100 days) was 2.7%. The estimated 2-year progression-free survival and overall survival rates were 67.2% and 78.5%, respectively. In conclusion, the full-dose HDT-ASCT regimen is feasible, safe and efficient in selected patients over 65 years old.