access to quality care for children with leukemia before the COVID-19 pandemic was already disadvantaged, with 5-year survival rates of 40%-60% compared to 90%-95% in developed countries. 1,2 Thus, safeguarding care of acute lymphoblastic leukemia (ALL) patients during the COVID-19 pandemic has represented a challenge.We analyzed 553 visits from 89 patients with ALL in "Hospital Universitario Dr. José Eleuterio Gonzalez." We conventionally administer all chemotherapy in an outpatient backbone. Some of the strategies implemented were increasing the capacity of infusion beds, offering telemedicine follow-up 24/7, continuing with the transplant program with outpatient intent, providing social support, and partnering with non-governmental organizations to assist families in paying for chemotherapy when needed. In our center, we did not modify or reduced intensity of the chemotherapy regimen. In addition, SARS-Cov-2-positive patients in induction received Capizzi chemotherapy regimen.Chemotherapy administration was timely and performed as per the protocol in 83% (n = 459) of the records reviewed. However, adherence was lower during the consolidation and intermediate maintenance phases (60.9% and 64%) and was associated with a shortage of cytarabine and methotrexate.The main causes of treatment delays were lack of financial resources (2.45), lack of inpatient beds (1.8%), and chemotherapy stock-outs (1.3%). In addition, the treatment abandonment rate was 3.3%.Other centers in low-and middle-income countries have reported their challenges during the pandemic, including missed or delayed diagnosis, chemotherapy shortages, shortfall of blood products, 3 and closure of HSCT programs. 2,4 Also, Gratz et al. reported decreased financial support, reduced clinical staff, and decreased available beds.The lack of availability of inpatient beds in our center was overcome by providing an ambulatory treatment regimen. If the treatment delay was >5 days, the 6-h outpatient infusion of methotrexate was implemented for low and intermediate risk. 5 During this time, 22 patients (24.7%) had a positive PCR test for SARS-CoV2; the median age was 5 years (range, 0.9-15). Two patients (9%) were diagnosed with COVID-19 and ALL simultaneously, eight patients (36%) during intensive phases of treatment, and ten (45%) with extended maintenance. In addition, two patients were diagnosed after haploidentical HSCT.The incidence of COVID-19 in our series was 24.7%, while other LA centers reported 13.1% and 58%. 6,7 Our mortality rate was 4.5%, similar to the global registry of Covid reported 8 ; however, another group in LA reported up to 37%. 6 Critical or severe illness was classified in 18%.Seven patients (32%) developed pneumonia, and two (9%) had multisystem inflammatory syndrome. Five (22.7%) required oxygen support, and two (9%) required mechanical ventilation. Three patients (13.6%) currently have late sequelae.The additional support interventions in our center allowed the continuity of ALL treatment for >80%. However, our high rate of abando...

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Introduction: Donor lymphocyte infusion (DLI) is a useful therapy for mixed chimerism (MC) or measurable residual disease (MRD) after allogeneic hematopoietic cell transplantation (HSCT) in patients with malignancies, while it is less effective for overt relapse and is limited by graft-versus-host disease (GVHD). Multiple DLI products can be obtained from a single leukoapheresis without granulocyte-colony-stimulating factor (G-CSF) priming, while cryopreserving surplus is an alternative for peripheral blood grafts. The ideal DLI CD3+ cell dose remains undefined ranging from 1-500x106/kg. However, leukoapheresis and cryopreservation are not risk-free, they are expensive and their costs prohibitive for many patients in developing countries. Furthermore, T-cell doses present in standard whole blood units can reach ≥1x106/kg in healthy donors which can be further increased after G-CSF exposure. For these reasons we have used G-CSF-primed whole blood units (WB-DLI) in HLA-matched and haploidentical (Haplo) transplant recipients and report our single-center experience. Methods: Patients ≥16 years of age who received WB-DLI at any time after HLA-matched related or Haplo peripheral blood HSCT due to relapse, MRD, MC or poor graft function were included from 2016-2018. Donors were stimulated with filgrastim 5 μg/kg every 24 hours for 3 days prior to donation. Standard pre-transfusion testing included major/minor crossmatch and flow cytometry analysis for lymphocyte subset quantification. The blood draw was performed on day 4 with the aim to collect 450 mL of whole blood in a standard collection bag. For patients with major and bidirectional ABO mismatch who had not undergone group switch or had a mixed population in solid-phase typing, a reactive major crossmatch was considered an absolute contraindication, while a reactive minor crossmatch was not. WB-DLI was infused fresh on the day of collection without manipulation in an outpatient basis. For relapsed patients, concurrent chemotherapy was administered on a case-by-case basis. Disease evaluation after relapse was performed on day +30 after treatment, while chimerism analysis was performed on day +60 through standard methods. GVHD prophylaxis was performed with oral cyclosporine A or tacrolimus and gradually tapered in a 60-day window. Results: Fourteen patients received a single dose of WB-DLI, median age was 32 years (16-67), 50% were female. Most common diagnoses were acute lymphoblastic leukemia, (n=5) and acute myeloid leukemia (n=5), followed by myelodysplastic syndrome (n=2), non-Hodgkin lymphoma (n=1) and chronic myeloid leukemia (n=1). Nine patients received Haplo grafts, while 5 were HLA-matched. Three patients had previous GVHD inactive at the time of WB-DLI. Indication for WB-DLI was relapse for 6 patients, 3 had MRD while 5 remained in remission; one patient received WB-DLI due to poor graft function. Median chimerism at the time of WB-DLI was 72% (range 38-100%). A single infusion was administered in all cases. Median mononuclear cell count obtained was 32x10x6/kg (range, 9-74), while median CD3+ cell count was 6.7x106/Kg (range 5.2-19). No immediate, severe adverse effects were observed. Febrile non-hemolytic transfusion reaction was documented in 4 cases after completing the procedure. No complications were observed in n=4 ABO mismatch cases including (n=2) major and bidirectional patients. Overall 50% of patients responded. Chimerism was improved in 50%, with a median increase of 28% (range 9-53%). Median post-DLI chimerism was 92.5% (range 20-100). Regarding patients treated for relapse or MRD, 3/9 patients responded (33%). Overall 8/14 patients eventually relapsed (57%) with a 12-month progression free survival of 27.5%, lower in relapsed/MRD positive patients (Figure I) (log rank test p=0.02 and 0.04, respectively). Overall survival at 12 months was 61.2%. Three patients developed acute GVHD, two of them grade III/IV in a median of 13 days (range 7-38). Four patients died due to relapse. Median follow-up after WB-DLI was 5 months (range 0.6-20.1 months). The cost of obtaining and administering WB-DLI was $350 USD per dose. Conclusions: DLI obtained from unmanipulated, GCSF-primed whole-blood is a safe and affordable adoptive cell therapy. It is effective and improves mixed chimerism after HSCT, while it was less effective for overt relapse. Disclosures Gomez-Almaguer: AbbVie: Consultancy; Novartis: Consultancy.

Introduction. Hematopoietic stem cell donors (HSCD) frequently suffer from anxiety and feelings that are usually unnoticed by the physician o their relatives. The origin is multifactorial: fear of pain, fear of the procedure, adverse effects of growth factor, feelings of responsibility regarding the success of the transplant, family pressure, etc. HSCD could show ambivalence of feelings about the donation, which may be related to the moral obligation to help a sick relative and fear of the donation procedure, thus originating anxiety and moral distress (MD). We evaluated the incidence of MD, anxiety, and other symptoms in a group of HSCD regarding donor related allogeneic transplantation. Materials and methods. A prospective observational study was carried out through a survey applied to 60 consecutive HSCD from April, 2014 to January, 2017. Protocol was approved by Institutional Ethics Review Committee and was carried out according to the Declaration of Helsinki. HSCD completed 3 written self-answered questionnaires (Questionnaire to assess moral distress (MDQ) elaborated by the researcher, State Trait Anxiety Index (STAI®) and Edmonton Symptom Assessment System (ESAS)) in three stages: right before initiating stem cell mobilization, immediately before the apheresis procedure, and 24 hours after the donation. Cell mobilization was done with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day/4 days while the apheresis collection was performed on the fifth day as an outpatient basis in all cases. Results. Sixty donors, 36 male and 24 female with a mean age of 38.2 years (SD = 13.6) were included. HSCD was a brother/sister of the patient in 39 cases (65%), and one parent in 21 cases. Regarding donor educational level, only 24 (40%) donors had university level. MDQ: Most donors felt happy to be the donor (97%), but 28% said they were not given the opportunity to accept or refuse being the donor, 10% would have preferred that another person had been the donor, and 5% mentioned that donation worsened their family relationship and they would not donate cells again if necessary. The number of donors with negative feelings regarding the donation decreased through the 3MD questionnaires (Table 1). STAI: In the first, second, and third questionnaire, the mean score for the state of anxiety was 12.1 (SD = 7.6), 10.3 (SD = 6.6), and 7.9 (SD = 5.7), respectively. In first STAI, mild to moderate anxiety was observed in 33% of the donors and severe anxiety was observed in 7%, observing a higher score in the first questionnaire, just before starting cell mobilization; however, that score gradually decreased in the following questionnaires. ESAS: In the first questionnaire, although no procedure was still performed, all donors had symptoms, including insomnia (33%), anxiety (33%), and tiredness (30%). In the second ESAS questionnaire, symptoms worsened, mainly pain (78%), tiredness (63%), and insomnia (55%), which was probably related to G-CSF. In the third ESAS questionnaire, there was a significant decrease in the symptoms: pain (60%), tiredness (50%), and discomfort (40%). The average global score for 10 symptoms evaluated was 10.5 (SD = 14.2), 20.1 (SD = 16.0), and 12.3 (SD = 14.4) for the first, second, and third ESAS questionnaires, respectively. According to the score given to each symptom, the most frequent disabling symptoms in each questionnaire were hyporexia (10%), pain (23%), and discomfort (15%) in ESAS questionnaire 1, 2, and 3, respectively. Higher scores for MD correlated with higher scores in STAI questionnaires as well as with lower levels of education (r=0.456, p< .005). Conclusions MD in the donor can manifest both clinically and socially through insomnia, fatigue, loss of appetite, anxiety, and ambivalence of feelings (happy to be the donor but feel morally obligated to donate) which may affect family relationships. Although there is no instrument to measure the MD before performing any procedure in the present study, the donors had different symptoms, such as negative feelings, anxiety, tiredness, difficulty to sleep, and even pain; all of them without an apparent physical reason. It is desirable that donors receive bioethical counseling and psychological guidance before the donation process in order to provide them with the necessary information regarding the experience they are about to endure. Disclosures Gomez-Almaguer: Amgen: Consultancy, Speakers Bureau; Teva: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau; Takeda: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau.