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Trasplantament de cèl·lules mare; Micafungina; Profilaxi Trasplante de células madre; Micafungina; Profilaxis Stem cell transplantation; Micafungin; Prophylaxis Introduction. The fungal infections remain an important problem in the allogeneic stem cell trasnsplantation (allo-SCT) setting and thus, anti-fungal prophylaxis is commonly used. The antifungal drug should offer activity, at least against Candida and Aspergillus spp., a good safety profile and low probability interactions. Micafungin could theoretically fulfill these requisites. The aim of the study was to describe the experience with micafungin as primary prophylaxis in patients undergoing allo-SCT in a cohort of Spanish centres, and to evaluate its ef-ficacy and tolerability in this population. Material and methods. Retrospective multicentre observational study including all consecutive adult patients admitted for allo-SCT in participating centres of the Grupo Español de Trasplante Hematopoyético (GETH), from January 2010 to December 2013, who received micafungin as primary prophylaxis during the neutropenic period. Results. A total of 240 patients from 13 centres were identified and 159 patients were included for the analysis. Most patients (95.6%) received 50 mg/day of micafungin. During the follow-up, 7 (4.4%) patients developed breakthrough invasive fungal disease, 1 proven and 6 probable; one patient discontinued the drug because of serious drug interactions. Prophylaxis with micafungin was considered effective in 151 (94.9%) patients. Conclusions. According to our experience, micafungin is an appropriate alternative for antifungal prophylaxis in patients undergoing an allo-HSCT, because its efficacy, its low profile of drug interactions and side-effects. Introducción. Las infecciones fúngicas siguen representando un problema en el trasplante alogénico de progenitores hematopoyéticos (alo-TPH) por lo que es habitual el uso de profilaxis antifúngica en estos pacientes. El tratamiento antifúngico debe presentar al menos actividad frente a Candida y Aspergillus spp, un buen perfil de seguridad y baja probabilidad de infecciones, siendo micafungina una de las opciones que podría cumplir todos estos requisitos. El objetivo del estudio fue describir la experiencia con micafungina como profilaxis primaria en pacientes sometidos a alo-TPH en una cohorte de hospitales españoles, y evaluar su eficacia y seguridad en esta población. Material y métodos. Estudio retrospectivo multicéntrico observacional consecutivo de todos los pacientes adultos ingresados para alo-TPH en los centros del Grupo Español de Trasplante Hematopoyético (GETH) desde enero de 2010 a diciembre de 2013 y que recibieron micafungina como profilaxis primaria durante el periodo de neutropenia. Resultados. Se identificaron 240 pacientes de 13 hospitales y 159 fueron incluidos para el análisis. La mayoría (95.6%) de ellos recibieron dosis de 50mg/día de micafungina. Durante el seguimiento, 7 (4.4%) pacientes desarrollaron infecciones de brecha, 1 probada y 6 probables; en un paciente se suspendió el tratamiento por interacciones medicamentosas graves. La profilaxis con micafungina se consideró efectiva en el 94,9% de los pacientes (151 de 159). Conclusiones. En base a nuestros resultados, consideramos que Micafungina es una buena alternativa como profilaxis antifúngica en pacientes sometidos a alo-TPH, por su eficacia, el bajo riesgo de interacciones y de efectos adversos. This study has been partially funded by Astellas.

On behalf of the Grupo Español de Trasplante Hematopoyético (GETH): et al., Graft-versus-host disease is the main cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. First-line treatment is based on the use of high doses of corticosteroids. Unfortunately, second-line treatment for both acute and chronic graft-versus-host disease, remains a challenge. Ruxolitinib has been shown as an effective and safe treatment option for these patients. Seventy-nine patients received ruxolitinib and were evaluated in this retrospective and multicenter study. Twenty-three patients received ruxolitinib for refractory acute graft-versus-host disease after a median of 3 (range 1–5) previous lines of therapy. Overall response rate was 69.5% (16/23) which was obtained after a median of 2 weeks of treatment, and 21.7% (5/23) reached complete remission. Fifty-six patients were evaluated for refractory chronic graft-versus-host disease. The median number of previous lines of therapy was 3 (range 1–10). Overall response rate was 57.1% (32/56) with 3.5% (2/56) obtaining complete remission after a median of 4 weeks. Tapering of corticosteroids was possible in both acute (17/23, 73%) and chronic graft-versus-host disease (32/56, 57.1%) groups. Overall survival was 47% (CI: 23–67%) at 6 months for patients with aGVHD (62 vs 28% in responders vs non-responders) and 81% (CI: 63–89%) at 1 year for patients with cGVHD (83 vs 76% in responders vs non-responders). Ruxolitinib in the real life setting is an effective and safe treatment option for GVHD, with an ORR of 69.5% and 57.1% for refractory acute and chronic graft-versus-host disease, respectively, in heavily pretreated patients., This study has been performed in collaboration with the Spanish Group of Hematopoietic Transplant and Cell Therapy (GETH). To the CIBERONC (CB16/12/00480).

BACKGROUND AND OBJECTIVES CD19-directed chimeric antigen receptor (CAR)-T-cell therapy is associated with early cytopenia in approx. 80% of patients and late cytopenia in 40% of patients. To date, the transfusion profile of patients undergoing these therapies has not been described. Our objectives are: To define the transfusion profile of CAR-T therapy in our setting.To evaluate clinical variables related to the intensity and duration of cytopenias. METHODOLOGY This is an observational, prospective, single centre study. Adult patients with lymphoproliferative disorders and acute lymphoblastic leukaemia proposed for CAR-T therapy from August 2019 to March 2021 were included. RESULTS 68 patients were included in the CAR-T cell therapy program. Table 1 describes patients characteristics. Forty-seven received CART therapy, apheresis was not performed in 7 cases (progression n=6, withdrawal of consent n=1), product was not infused in 9 patients due to disease progression and 5 patients are awaiting infusion. Cytokine release syndrome (CRS) occurred in 79% of patients, 25% developed grade≥2 and median time to onset was 2 days (IQR, 1-4 days). Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 33% of patients, 16% were grade≥3 and median time to onset was 7 days (IQR, 6-8 days). Median duration of hospital admission was 14 days (IQR, 12 to 21 days). None of the 47 infused patients had neutropenia or anemia in the transfusion range prior to lymphodepletion. 94% (44/47) developed grade ≥3 neutropenia, with a median duration of 14.5 days (IQR, 9.75 to 36 days). G-CSF was administered to 21 patients, with a median time on G-CSF of 115 days (IQR, 27-258 days). A total of 239 red blood cells units (RBC) have been transfused, median 3.5 RBC/patient (IQR, 0 to 7.5 RBC / patient). 70% of this consumption occurred in the first 30 days after infusion. Before CAR T cell infusion, 2 patients had a platelet count 20x10 9/L was 17 days (IQR, 4-54 days) and > 50x10 9/L was 39 days (IQR, 20-79 days). 62% of patients received ≤2 platelet concentrates (PC). However, 21% had long-term thrombocytopenia (> 30 days). This group received a median of 15 PC (IQR, 12-27). The amount of PC used was 198, 52% were administered in the first 30 days. Eltrombopag was indicated in 9 of the 25 patients with grade ≥3 thrombocytopenia, doses never exceeded 75 mg/day. No serious bleeding (WHO grade ≥2) was observed. Factors related to severe thrombocytopenia were female (74% vs 42%, p=0.036), CRS (61% vs 0%, p=0.019), ICANS (80% vs 43%, p=0.020) and use of steroids (92% vs 67%, p=0.003). We found no relationship with underlying disease or status, prior treatment lines, prior autologous transplantation, CAR-T product, duration of lymphopenia, time and duration of CRS or ICANS. With a median follow-up of 167 days (IQR, 73-303 days), 26% of patients died, causes of death were infections n=2 and disease progression n=10. Three months after the procedure, there were 30 evaluable patients for response and 64% remained in remission (47% CR, 17% PR). CONCLUSIONS A high percentage of patients receiving CAR T cell therapy present long-term cytopenias. Reserves of irradiated blood components must be foreseen. Development of CRS and ICANS could be prognostic factors for the development of long-term grade ≥3 thrombocytopenia. Studies are needed on the use of thrombopoietin receptor agonists to reduce the duration of thrombocytopenia, although effective doses could be higher than those used in idiopathic immune thrombocytopenia. Figure 1 Figure 1. Disclosures Reguera: Janssen, Kite/Gilead, Novartis: Speakers Bureau; BMS-Celgene, Novartis: Membership on an entity's Board of Directors or advisory committees. Perez-Simon: JANSSEN, TAKEDA, PFIZER, JAZZ, BMS, AMGEN, GILEAD: Other: honorarium or budget for research projects and/or participation in advisory boards and / or learning activities and / or conferences.

Introduction Several studies have shown that the minimal residual disease (MRD) in acute myeloid leukemia (AML) patients has a prognostic value after induction and consolidation therapy. Nevertheless the relapse is the most important cause of treatment failure in these patients, although they achieved a negative MRD, and even after an allogeneic hematopoietic stem cell transplantation (allo-HSCT). Nowadays, the value of the MRD before allogeneic BMT is still controversial. Method Multicentric study where we have studied correlative AML patients who went under an allo-HSCT in a situation of complete response, between 2012 and April'18. The MRD was analyzed by 8-coloured multiparametric flow cytometry, at least with 2 tubes per patient and 1,000,000 events per tube. We evaluated the prognostic value of the MRD before allo-HSCT. Results Between January'12 and April'18 we have gathered 90 allogeneic BMT in AML patients who were in CR, with a median age of 45 years old (17 - 66). The pre-HSCT situation was 1st complete remission (CR) in 75 patients and 2nd CR in 15. In 45 patients the conditioning regimen was myeoablative. In the group of patients (67) where we could know the risk group at diagnosis, the distribution was: low risk 18%, intermediate risk 59.7% and high risk 22.4%. The 46.7% of the donors were not related. In the last follow-up after allo-HSCT 24 patients have suffered a relapse (26.7%) and 41 (45.5%) have died (17 cases of mortality related to the transplant and 24 not related). In the global analysis the median follow-up of the overall survival (OS) was 37.5 months. Among the 90 patients, MRD was valuable in 86. Ten of 59 patients (16.9%) with negative MRD relapsed vs 12/27 (44.4%) with positive MRD, p= 0.016. If we consider only patients in 1st CR, 9/50 (18%) patients with negative MRD relapsed vs 10/22 (45.5%) with positive MRD, p= 0.02. This statistically significant difference does not exist if we consider only patients in 2nd CR. The median follow-up of OS and event free survival (EFS) was not reached in the negative MRD group and 571 days and 299 days in the positive MRD group. OS and EFS at 2 years after transplantation were 65% and 64% in the negative MRD group and 42% and 37% in the positive MRD group, p= 0.03 and p= 0.008 respectively (figure 1). Conclusions The detected MRD by 8-colour multiparametric flow cytometry previous an allo-HSCT in patients with AML in 1st CR is a prognostic factor in terms of relapse. Patients with a positive MRD before the allo-HSCT have a poorer OS and EFS than the patients with a negative MRD. Figure 1. Figure 1. Disclosures No relevant conflicts of interest to declare.