ALBERT

Description: INTRODUCTION: Graft versus host disease (GvHD) is a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation (HSCT). ATG-Fresenius (ATG-F) has demonstrated its efficacy in reducing the risk of acute GvHD (aGvHD) and chronic GvHD (cGvHD) at a dose of 60 mg/kg (Finke J, Lancet Oncology, 2009; Sociè G, Blood, 2011), and at a dose of 30 mg/kg (Ayuk F, Biol Bone Marrow Transplant, 2008; Solano C, abstract EBMT, 2015). AIMS: We analyzed as primary endpoint whether low dose ATG-F (21-32 mg/kg) might be effective in reducing the incidence of acute and chronic GvHD. The secondary endpoints were viral infections, non-relapse mortality (NRM), disease free survival (DSF) and overall survival (OS). METHODS: Between September 2012 and December 2014, 22 patients who underwent HSCT received ATG-F in our hospital. Two patients were excluded because they received a second HSCT. We used ATG-F at a dose of 21 mg/kg (7 mg/Kg days -3,-2,-1) in the case of patients with hematologic malignancies who received a HSCT from an unrelated donor (UnD) with peripheral blood (PB) source and/or from a mismatched donor (MMD). ATG-F at a dose of 28-32 mg/kg (7-8 mg/kg days -4 to -1) was employed in aplasia. Median age was 53 years (9-68) and only 5 patients were

Description: Background: Patients with high-risk FL intensified with HDT/ASCT may achieve prolonged remissions. The best timing for the procedure remains controversial. Patients who are transplanted in first response show a major Progression Free Survival (PFS) and Event Free Survival (EFS) advantage compared to those treated with conventional chemotherapy. Nevertheless, no randomized studies have yet shown an overall survival (OS) benefit. Populational-based and very long-term retrospective analysis are indispensable tools to assess the actual impact on outcome of therapeutic interventions in FL. With this assumption we performed a retrospective analysis in FL patients undergoing HDT/ASCT intensification included in the GELTAMO Spanish Group Registry. Objectives: The overall outcome as well as the clinical evolution according to the disease status at transplant, to the Follicular Lymphoma International Prognostic Index (FLIPI and FLIPI II) and to the previous exposure to Rituximab. Series characteristics: Six hundred and sixty six patients with FL (mean age 47 years, male 49%) undergoing HDT/ASCT between 1989 and 2007 were reported to the GELTAMO registry. Patients with histological transformation at the time of HDT/ASCT, those undergoing a 2nd transplant and those with a follow-up of less than 7 years were excluded. Thus, 640 patients were included in the analysis. Median follow-up was 12.2 years from HDT/ASCT and 14.2 years from diagnosis. Follow-up from HDT/ASCT was over 16 years for 153 patients (3rd quartile). The median time from diagnosis to HDT/ASCT was 1.8 years. Two hundred and forty-seven patients (38%) never achieved a complete remission (CR) before HDT/ASCT. Two hundred patients (31%) received HDT/ASCT after achievement of first CR (CR1), 43% of them requiring more than one chemotherapy line to achieve CR1; 26% in 2nd CR, 5% in 3rd CR, 21% in 1st partial response (PR), 12% in chemosensitive recurrence, and 5% with active disease. Of the 321 patients assessable for the FLIPI, 33% had a low-risk (LR), 36% an intermediate-risk (IR), and 45% a high-risk (HR) score; and of the 305 patients assessable for the FLIPI II, 22% had a LR, 38% an IR and 40% a HR. Of the 127 patients in CR1 assessable for the FLIPI, 28% had a LR, 40% an IR, and 32% a HR; of the 115 patient assessable for FLIPI II, 14% had a LR, 46% an IR, and 40 % a HR. One third of patients received Rituximab prior to transplant. Results: Median PFS and OS were 9.4 and 21.3 years, respectively. Patients transplanted in CR1 achieved significantly better final PFS (68%) and OS (73%), than those transplanted in 2nd CR (median PFS 110 months (mo.) and final OS 58%; P

Description: Introduction Thymoglobulin (ATG) infusion-related reactions in stem cell transplant (SCT) recipients are frequent. Minor reactions as fever and chills are the most usually observed. Severe and potentially life-threatening reactions are rare (〉1/10.000 and

Description: INTRODUCTION Biosimilars are approved biologics with comparable quality, safety and efficacy to a reference product for which patent protection has expired. Biosimilars of recombinant human granulocyte-colony stimulating factor (G-CSF) have been available for more than 8 years now and are widely used in Europe; however, there are still some concerns regarding their long-term safety and immunogenicity. The objective of this study was to evaluate the efficacy and safety of the biosimilar G-CSF (Zarzio) to mobilize stem cells in the autologous hematopoietic stem cell transplantation (HSCT) setting. METHODS We retrospectively reviewed 209 consecutive patients undergoing peripheral blood stem cells harvest between December 2009 and December 2015 using the biosimilar G-CSF. The target CD34+ stem cell dose at our institution is 2 x 106/kg for autologous HSCT. A survey to evaluate the potential side effects related to the mobilization process was conducted during the follow-up. RESULTS The median age at the time of harvest was 56 years old (range: 16-75) and 113 (54,1%) patients were male. The indication for autologous HSCT was lymphoma in 102 (48,8%) cases, plasma cell neoplasm in 90 (43%), acute leukemia in 12 (5,8%), non-haematological malignancy in 3 (1,4%) and autoimmune disorder in 2 (1%). The patients had received one (n=86; 41,1%), two (n=89; 42,6%) or more than two (14,4%) lines of treatment before mobilization. Only 4 (1,9%) cases had not received prior lines of chemotherapy. Patients were primed with the biosimilar G-CSF alone (n=64) or following a cycle of chemotherapy (n=145). Additional Plerixafor was administered in 31 cases (14,8 %) because peripheral CD34+ count was too low or the patient had poor baseline predictors. Sufficient CD34+ cells were collected with a single priming procedure in 195 (93,3 %) cases and 14 (6,7 %) underwent a second mobilization. Only 4 (1,9 %) patients did not reached the target CD34+ stem cells dose. The median number of harvest days required per patient was 1 (range: 1-5) and the median total CD34+ cells x 106/kg collected was 4,08 (0,36 - 57,42). In 18 (8,6%) patients autologous HSCT was cancelled due to disease progression (14 lymphomas, 3 acute leukemias and 1 Waldenstrom macroglobulinemia). The remaining patients (n = 191) received high dose chemotherapy followed by autologous stem cell infusion. The median CD34+ cells x 106/kg infused was 4,02 (1,79 - 28,71). The median post-HSTC days to neutrophil (〉0,5 x 109/l) and platelet (〉20 x 109/l) engraftment were 12 (range: 7-31) and 12 (8-60) respectively. Three (1,4 %) patients died before engraftment on days 5, 7 and 8 post-HSCT (2: Toxicity related to the conditioning regimen; 1: Bacterial hemorraghic enterocolitis). Sixty-four (30,6 %) patients reported bone or muscle pain during the first weeks following the use of the biosimilar G-CSF but no severe adverse effects were reported after a median follow-up of 31 (1 - 75) months. CONCLUSIONS The target CD34+ stem cells dose was collected in almost all the cases showing that the biosimilar G-CSF was effective for the mobilization process in our patients. The biosimilar G-CSF was also safe with only one third of the patients reporting non-severe side effects being the most common bone or muscle pain. Disclosures No relevant conflicts of interest to declare.

Description: Introduction Thrombocytopenia is a common complication after allogeneic hematopoietic stem cell transplantation (allo-SCT). Underlying mechanisms are poorly known and usually multifactorial. Its treatment is not well defined, mostly based in platelet transfusion. Thus, is important to identify new strategies to manage this important post-SCT complication. Romiplostim and Eltrombopag are currently available thrombopoietin receptor agonists (TPO-RAs) that stimulate platelet production. Some studies with very small number of cases have reported their potential efficacy in the allo-SCT setting. For this reason, the aim of our study is to analyze the efficacy and safety of TPO-RAs for severe and persistent thrombocytopenia after allo-SCT. Patients and methods We performed a retrospective multicenter study including patients from centers of GETH with prolonged isolated thrombocytopenia (PT) or secondary failure of platelet recovery (SFPR) after allo-SCT. PT was defined as the engraftment of all peripheral blood cell lines but with platelet count ≤20000/µL for 7 consecutive days or requirement of transfusion for more than 60 days after allo-SCT. SFPR was defined as a decline of platelet counts to ≤20000/µL for 7 consecutive days or requirement of transfusion after achievement platelets ≥50000/µL without transfusion for 7 days post-SCT. The primary endpoint was platelet recovery to ≥50000/µL. Results Eighty-six patients with thrombocytopenia after allo-SCT were included. The characteristic of the patients, are summarized in table 1. Sixteen (19%) of the patients had PT and 71 (82%) SFPR. TPO-RA was started at a median time of 127 days (27-1177) after allo-SCT (41% Romiplostim / 59% Eltrombopag). Median initial and maximum administered doses were 50 mg/daily (25-150) and 75 (25-150) for Eltrombopag and 1 µg/kg (1-7) and 5 (1-10) for Romiplostin, respectively. Eighteen patients (21%) were previously treated with cell infusion (67% mesenchymal cells and 33% CD34+ boost). Median platelet count before TPO-RA onset was 14000/µL (1000-57000). Platelet recovery to ≥50000/µL was 60% and the response was achieved at a median time of 56 days (2-247). Responses were similar considering all potential causes of thrombocytopenia evaluated. 81% of the patients had decrease number of megakaryocytes prior to treatment showing a worse response to therapy: median time to ≥20000/µL platelets 43 days versus 28 days (p=0.011), with also a lower rate of platelet recovery to ≥50000/µL (62% versus 85% if normal megakaryocytes). In patients treated with Eltrombopag, 27% had neutropenia 1000/µL after therapy. The median treatment duration was 62 days (7-700) and 62% discontinued TPO-Ra maintaining response. Grade 3-4 adverse events (hepatic and asthenia) were observed in only 2% of the cases. At last follow up with a median of 10 months (1-59), 72% of the patients maintained the response and 61 (71%) were alive. Death rate was significantly lower in responder-patients to TPO-RAs, 15% versus 53% in non-responders (p

Description: Introduction The best conditioning regimen in allogeneic stem cell transplantation (SCT) for myeloid malignancies is unknown. In the last decade, conditioning regimens based on busulfan (BU) and fludarabine (FLU) have shown a good security profile with low early toxicity and mortality but long term follow up is needed to confirm the efficacy in the disease control. Objective To analyze retrospectively the efficacy (overall survival OS, progression free survival PFS) of the conditioning regimen with FLU (40mgr/m2/4 days) and BU (3,2 mgr/kg once daily/4 days) in adult patients with myeloid neoplasms after SCT. Outcome was assessed considering age, comorbidity, disease, and donor. Patients and transplant characteristics Between 2006 and 2012, 90 patients (40 males, 50 females) underwent SCT conditioned with FB4 in our center. The median age of patients was 50 (24-74) years and 34 patients (37%) were older than 55 years. The diagnoses were 65 AML (11 secondary AML and 19 with adverse cytogenetic), 19 MDS (11 with IPSS high/intermediate 2) and 6 MPD (3 CML, 3 myelofibrosis). At time of SCT, 52 patients (80%) with AML were in first CR. High risk disease (secondary AML or with adverse cytogenetic and MDS with high/intermediate IPSS) were considered in 41 patients (45%). The HCT comorbidity index (Sorror) was low, intermediate or high in 20 (22%), 31 (34%) and 39 (43%) patients, respectively. Donor type was matched related in 42 patients (47%), matched unrelated in 30 patients (33%) and mismatched unrelated in 18 patients (20%). Stem cell source were bone marrow in 81 cases (90%). GvHD prophylaxis was done with calcineurin inhibitor associated with short course of methotrexatre or mycophenolate in all patients and Thymoglobulin was administered in 8 patients (9%). Results All patients but one engrafted. The median time to recovery 〉500 ANC/uL and 〉50000 platelets/uL was 16 days (range, 9-28) and 16 days (range, 11-455) respectively. Donor complete chimerism was achieved during first or second month in 90% cases. The incidence of acute GVHD grade II-IV and III-IV was 45% and 12% respectively. Chronic GvHD was diagnosed in 60 patients (68%) (26 mild, 18 moderate and 16 severe) and 22 patients (36%) had pulmonary affectation. Transplant related mortality at 100 days and 1 year was 5.5% and 15%. With a median follow up of 26 months (IQL 12-45), the estimated overall survival (OS) was 64% and progression free survival (PFS) was 61%. To be more than 55 years at time of SCT had a negative impact on survival (estimated OS at 40 months: 42% vs 75%, p=0.005). Neither HCT comorbidity index nor disease type had a significant influence on estimated OS at 40 months (70%, 62% and 58% in low, intermediate and high risk) and (64% in AML and 51% in MDS) respectively. However considering the group of high risk disease had worse OS (53% vs 78%, p=0.07). Although there was no significant difference, the OS in mismatched unrelated SCT was worse than matched unrelated and related SCT (40%, 63 % and 71%). Conclusion Conditioning regimen with fludarabine and busulfan (FB4) offers a good effectiveness in patients with myeloid neoplasms and allow the use of myeloablative regimen in patients with high risk disease and significant comorbidities. Only the age at time of SCT had a statically significant impact on overall survival. Disclosures: No relevant conflicts of interest to declare.

Description: INTRODUCTION: Allogeneic hematopoietic stem cell transplantation (alloSCT) is the only curative strategy for relapsed/refractory T cell lymphoma (T-NHL). In the past ten years, there have been several improvements in conditioning regimens and graft versus host disease prophylaxis (GVHD), which have contributed to lower transplant-related mortality (TRM). Also, selective and low toxicity therapies, might improve response quality in some T-NHL Recently, haploidentical stem cell transplantation (Haplo) with post-transplant cyclophosphamide is a new option for those patients who do not have an HLA-identical sibling or a suitable unrelated donor, but also it has shortened the time for urgent cases. METHODS: This study analyzes overall outcomes of 211 consecutive patients diagnosed with T-NHL who received an alloSCT from 1995 to 2018 in GELTAMO/GETH centers. Previous therapies (chemotherapies and autologous stem cell transplantation) and baseline diagnostic parameters were recorded. RESULTS The median age at alloSCT was 47 years (range, 17-69). (see table 1). Forty-nine (23%) had primary extranodal disease. Disease status pre alloSCT was available in 202 patientes: 54% were in complete response (CR), 30% in partial response (PR) and 16% with stable/progressive disease (PD). Since 2013 BV was used as a bridge therapy in ≥ 3rd line in 25 patients with CD30+ tumor expression, it was effective in 20 (CR 68% (n=17), PR 12% (n=3) PD 16% (n=4), not assessed in 1 case). The use of BV was not associated with a better response probability pre alloSCT compared with other regimens used after third line and it did not impact on post alloSCT outcomes. Reduced intensity conditioning (RIC) was the most frequent (76%, n=156). (see table 2) GVHD prophylaxis were Methotrexate + CsaA or Tacrolimus (n=72, 35,8%), sirolimus-tacrolimus (n=37; 18,4%), Cy-post based (n=44, 21,9%; used in Haplo setting n= 29). The median follow-up of all cohort was 22.5 months (range, 0-280). The two year overall survival (OS) and disease free survival (DFS) were 60% (CI95%, 53-67%) and 76.7% (CI95%, 69.3-82.5%) (Figure 1A) We observed a significant improvement in alloSCT outcomes since 2011 (OS

Description: Background:High dose therapy supported by autologous stem cell transplantation (HDT/ASCT) has been a treatment frequently indicated in follicular lymphoma (FL) patients and has contributed to modify the natural history of the disease. Secondary neoplasia is one of the concerns after HDT/ASCT, although its incidence after transplant-free treatments is considerable (RummelM et al. Lancet Oncol 2016; Sacchi S et al. Haematologica 2008). The high incidence of secondary neoplasia in some of the studies, together with the lack of OS advantage in transplanted patients compared to those treated with conventional Chemo/R, has led to abandon HDT/ASCT by many groups. However, its incidence is very variable among studies due in part to cohort different in terms of age, pre-ASCT treatments, used of TBI-based or TBI-free conditioning regimen or length of follow-up. Methods:The Incidence of secondary neoplasia, the factors associated with its development and the survival of 655 FL patients reported to the Spanish GELTAMO registry and intensified with HDT/ASCT between 1989 and 2007 with a median follow-up of 12.3 years from HDT/ASCT and 14.5 years from diagnosis were analyzed. Baseline characteristics and therapeutic-related data are listed in the table. Standardized Incidence Ratios (SIR) were calculated to assess the risk of a second malignancy by dividing the number of observed second malignancies with the number of expected sex matched incidence using the 2008 crudes rates in the Spanish population (J Farley et al. EJC 2013). Data were updated with a cut-off date of 31 June 2016. Results:Median OS were 21.3 years from HDT/ASCT and 22.6 years from the time of FL diagnosis. A total of 83 patients (12.75%) developed 85 second malignancies. There were 45 cases of solid tumors (51%), including 8 skin cancers; 34 cases of Acute Myeloid Leukemia or Myelodysplastic Syndromes (AML/MDS) (40%); 2 Acute Lymphoblastic Leukemia (ALL), 1 chronic myeloid leukemia (CML), 1 Hodgkin lymphoma (HL) and 2 cases of other cancers. The accumulated incidence at 5, 10 and 15 years were 6.7%, 12% and 17.8%, respectively. The incidence for solid tumors and AML/SMD were 2.1%, 4.1%, 9.5% and 3.1%,6.4% and 8,1% at 5, 10 and 15 years, respectively. Median time from HDT/AST to the diagnosis of the second malignancy was 5.5 years (IQR 3.2-9.6). Solid tumors and AML/SMD were documented with a median time of occurrence since HDT/ASCT 7.7 years (IQR 3.2-9.9) and 4.2 years (IQR 1.7-7.3), respectively. The SIR for second neoplasia was 2.8 (CI 95%: 2.6-2.9) and only 1.4 (CI 95% 1.3-16) in the case of solid tumors. Only male sex (P=.006) and the use of anthracycline at first line therapy in the case of solid tumors (P=.02) were associated with an increased number of second neoplasia. Older age and a status of disease before HDT/ASCT different to complete response showed a tendency. There were no differences according to the use of fludarabine or rituximab previously to HDT/ASCT, number of therapy lines before HDT/ASCT, time from diagnosis to HDT/ASCT or conditioning regimen. Median OS for patients with second neoplasia is 12 years from the time of FL diagnosis, 9.4 years from ASCT (fig 2)[14.5 y. for solid tumors and 8 y. for sMDS/sAML (P=.01)] and 1.5 years from the time of diagnosis of second neoplasia [2.3 y. for solid tumors and 1.25 y. for sMDS/sAML (P=.01)], respectively Conclusion: This very long follow-up study, that includes patients from the rituximab era, indicates that FL patients undergoing an ASCT are at an increased risk of developing a 2nd malignancy, especially AML-MDS. However, the incidence is not higher than the reported in other series without transplantation. Only male sex and the use of anthracyclines were associated with an increased risk of 2nd neoplasia. Given the favorable survival obtained by ASCT in FL, the risk of secondary neoplasia shouldn't preclude its application. However, once a neoplasia is diagnosed the prognosis is dismal. Thus, a carefully selection of patients candidates to HDT/ASCT is necessary. Table Table. Figure Figure. Disclosures Lopez-Jimenez: Abbvie: Membership on an entity's Board of Directors or advisory committees; Velgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; MSD: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; MundiPharma: Honoraria, Membership on an entity's Board of Directors or advisory committees. Martín:Sevier: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria.

Description: BACKGROUND AND OBJECTIVES. Post transplantation High dose Cyclophosphamide (PTCY) used in haploidentical hematopoietic transplantations, has a high effectivity in acute Graft versus Host Disease (aGVHD), and chronic Graft versus Host Disease prophylaxis (cGVHD), however it is associated with high relapse rates. On the other hand, Anti-T-Lymphocyte Globulin (ATG-Fresenius ®) is also effective as immunosuppressive (IS) drug, but its benefit on Overall Survival (OS) and Relapse Free Survival (RFS) is unclear. The aim of this study was to compare the effectiveness of two GVHD prophylaxis regimes used in high risk transplantation: PTCY used in Haploidentical transplantation and ATG used for peripheral blood, non-related, related and mismatched donors. The primary endpoint was to evaluate the incidence of aGVHD and cGVHD, and its severity in both groups. As secondary endpoints we analyse the OS, RFS and GRFS (recorded adverse events include grade 3-4 aGVHD, systemic therapy-requiring cGVHD, relapse or death during median follow-up). We also consider transplantation related mortality (TRM) and post-transplantation complications. PATIENTS AND METHODS. We retrospectively analyse 111 allo-transplantations performed at our institution between 2012 and 2017. We analyse two cohorts: 49 haploidentical transplantation with PTCY (50 mg/kg, on day +3, +4) followed by Tacrolimus and Mycophenolate; and 62 peripheral blood related, non-related and mismatched with low dose ATG Fresenius (7mgr/Kg on days -3, -2, -1) associated with Tacrolimus/Cyclosporine starting on day -1 with a short course Methotrexate (on day +1, +3, +6) or Mycophenolate. Mycophenolate was stopped on day +28 and Cyclosporine or Tacrolimus were tapered on day +50. RESULTS. There were no differences in patients' age (49 vs 51), sex or pre-transplantation HCTI-score ≥ 3 (30 vs 26) between PTCY and ATG groups. We found differences between diagnosis (lymphoproliferative disorders (16 vs 4, p= 0.003), high DRI-score (18 vs 11, p = 0.04), number of previous transplantations (12 vs 5, p= 0.02), reduced intensity conditioning regimen (36 vs 20, p 〈 0.001) and bone marrow as stem cells source (38 vs 9, p 〈 0.001) between PTCY and ATG groups. The median time to neutrophil engraftment (〉500/uL) was similar: 17 days [13-34] for PTCY and 16 days [9-33] for ATG. Median time to platelet recovery was higher in PTCY cohort (33 vs 18 days, p= 0.016). There were 3 secondary graft failures in PTCY group vs 4 graft failures in ATG (3 primary, 1 secondary). The were no differences in grade 2 - 4 aGVHD incidence between groups (PTCY:30.6% vs ATG:36.4%), but we found differences in grades 3 - 4 aGVHD (PTCY:4.1% vs ATG: 9%, p=ns). The global incidence of any NIH grade cGVHD was 56.1% in PTCY vs 66% in ATG group. Mild, moderate and severe cGVHD incidence were 31.7%, 19.5% and 4.8% for PTCY vs 28%, 26% and 12% in ATG (p=ns). The median duration of IS in alive patients with cGVHD was 6.5 months [3-19] in PTCY patients and 10 [3-34] in ATG group. Among moderate and severe forms, the median IS duration was 10 and 5 months in PTCY group vs 13 and 12 months in ATG respectively. PTCY cohort developed more non-infectious complications, especially, cardiac, lung, digestive and neurologic complications, (p=0.086), however there were not differences in infectious complications (Table 1). TRM was similar between groups, 18.4% for PTCY vs 22.5% for ATG, (p=0.250). We didn´t find differences in early toxic mortality (

Description: Introduction: At present, determining OS (Overall Survival) remains the gold standard in clinical trial endpoints which evaluate the role of ASCT in FL. However, in the context of a disease characterized by very long median survivals with a continuous pattern of relapse, and still more with the advent of novel treatments, OS assessments seem elusive. In fact, PFS (Progression Free Survival) is the standard endpoint for new drug approvals in first-line FL, and some other earlier endpoints such 2-year PFS (Casulo et al , JCO 2015) or CR30 (Sargent, 2015) have been recently proposed as potential surrogates and as alternatives to PFS or OS as primary end-points in FL patients treated with 1st line chemoinmunoterapy. Objective: To assess if 2-year PFS and CR30 are feasible surrogates of OS in the setting of a very long follow-up series of FL patients treated with ASCT. Material and Methods: A total of 626 chemosensitive FL patients (mean age 47 years, male 49%) reported to the Spanish GELTAMO registry and intensified with ASCT between 1989 and 2007 were analyzed. The status of the disease at the moment of ASCT was either in 1st response [203 in 1st CR, 43% of them needing more than one therapy line to reach the CR, and 140 in 1st Partial Response (PR)] or in response after salvage therapy (174 in 2nd CR, 28 in 3rd CR and 81 in 2nd or 3rd PR). In 615 patients the status of the disease was evaluable after ASCT: 569 cases (92%) in CR, 27 cases (4%) in PR and 19 cases (3%) progressed or died. To assess 2-year PFS, two groups were defined: patients with progression of disease (POD) within 2 years from ASCT (early POD) and patients without progression within 2 years from ASCT. Cox model analysis was used to evaluate the association between early POD and OS from a risk - defining event, which is survival from time of POD for early progressors or from 2 years after ASCT for the reference group (Casulo et al, JCO 2015.Appendix). To asses CR30, two groups were defined: patients with and patients without CR at 30 months from ASCT. Cox model analysis was used to evaluate the association between being or not in CR at 30 months from ASCT. Results: Median follow-up is 12.2 years from ASCT and 14.2 years from diagnosis. Of the assessable patients, 31% were in the high-risk FLIPI group and 40% in the high-risk FLIPI 2 group. 30% of patients received rituximab prior to ASCT. Globally median PFS and median OS are 11 and 21 years, respectively. Patients transplanted in PR (n=221; 35%) had a worse OS than those transplanted in CR (n=405, 65%): HR 2.45 (95% CI, 2.2-2.7; P