In the relapsed/refractory setting for treatment of large B-cell lymphoma (LBCL), chimeric antigen receptor T-cell (CAR-T) therapy has emerged as an effective treatment modality. Patients often have aggressive disease that requires prompt treatment in the form of bridging therapy (BT) for disease stabilisation while CAR-T cells are manufactured. Patients (n = 75) undergoing CAR-T therapy infusion for LBCL at our institution were identified. A total of 52 (69Á3%) received BT and 23 (30Á7%) received no BT (NBT). BT modalities included systemic BT (SBT) in 28 patients, radiation BT (RBT) in 14, and high-dose steroid BT (HDS) in 10. There was no difference in incidence of cytokine release syndrome or immune effector cellassociated neurotoxicity syndrome between BT and NBT (P = 0Á18 and P = 0Á53 respectively). Prolonged cytopenias at Day 180 were more common in BT than NBT (50% vs. 13Á3%, P = 0Á04). The SBT and RBT subgroups had more cytopenias at Day 180 compared to the HDS and NBT subgroups (58Á3% and 57Á1% vs. 20% and 13Á3% respectively, P = 0Á04). Disease response at last follow-up, progression-free survival and overall survival were similar between BT, NBT, and BT subgroups. In summary, BT can be safely considered in patients undergoing CAR-T therapy. However, those undergoing BT with SBT or RBT are at higher risk of prolonged cytopenias after CAR-T therapy.

Ribavirin is used in the treatment of respiratory syncytial virus (RSV) in high-risk patients, including patients who have undergone hematopoietic stem cell transplantation, to reduce mortality from RSV pneumonia. It is classified as a hazardous drug with potential for carcinogenicity and teratogenicity. Very few recent studies have examined the risk of exposure, and recommendations for exposure precautions are lacking. Administration should include the use of personal protective equipment and terminal cleaning of the patient room after each administration. This article examines ribavirin use among patients who have undergone hematopoietic stem cell transplantation and have RSV-related pneumonia and explores safety considerations for staff. Nursing leaders on a hematopoietic stem cell transplantation unit addressed gaps in knowledge about ribavirin therapy, and completed a review of the hospital's ribavirin policy, which led to policy revisions, increased knowledge about the safe administration of ribavirin, and improvements in staff and patient education.

Autologous bone marrow transplantation (BMT) has not been curative in chronic myeloid leukemia (CML), because of the inability to purge CML from the autograft and the absence of the allogeneic T cell-mediated antileukemic activity. However, recent advances demonstrate that normal progenitors can be selected from CML marrows by a variety of techniques, including isolation by their small size. Furthermore, we found that myeloid growth factors have a potent antileukemic effect against CML progenitors in vitro by inducing their terminal differentiation. Based on these data, we initiated a trial of autologous BMT in patients with high-risk CML. Autografts were processed in an attempt to enrich for normal progenitors, first by isolating small cells by counterflow centrifugal elutriation and then incubating them in granulocyte-macrophage colony-stimulating factor (GM-CSF) for 72 hours. After a conditioning regimen of busulfan and cyclophosphamide, all patients received GM-CSF daily for 2 months. The median age of the 13 patients in the trial was 45 years (range 17-56 years). The median duration of disease before BMT was 24 months (range 13-72 months). Eight patients were in chronic phase (CP), and five were in accelerated phase (AP). All patients failed to achieve a cytogenetic response to interferon-alpha and were 100% Philadelphia chromosome (Ph)+ before BMT. There were three transplant-related deaths, all AP patients. All of the remaining 10 patients engrafted with some degree of Ph- hematopoiesis; despite high-risk features, nine patients engrafted 100% Ph-. All patients relapsed cytogenetically at a median of 6 months (range 4-22 months). These results demonstrate that autologous BMT can consistently induce complete Ph- engraftment in CP patients. GM-CSF appears to produce a clinical antileukemic effect against CML after autologous BMT.

893 Background: Oral mucositis is a debilitating and frequently encountered consequence of high-intensity chemotherapy used prior to and after bone marrow transplantation (BMT). It is associated with increased acute oral pain, use of total parenteral nutrition (TPN) and intravenous narcotic analgesics, length of hospital stay, incidence and severity of graft-versus-host disease (GVHD), risk of severe infections, and mortality. Important contributors to the duration and severity of mucositis include certain agents used in the conditioning regimen and as GVHD prophylaxis, especially methotrexate (MTX). High dose post-transplantation cyclophosphamide (PT/Cy) has been shown to be effective as a single-agent prophylaxis of GVHD after HLA-matched BMT. Due to the reduced toxicity profile of Cy compared to MTX, we sought to characterize mucositis among patients receiving PT/Cy, and to compare it to historical controls receiving cyclosporine A (CsA) and MTX as GVHD prophylaxis. Methods: We performed a retrospective record review of 142 consecutive patients treated at our institution between June 2004 and October 2009 who received a standard regimen of busulfan (Bu) 4 mg/kg/day orally or 3.2 mg/kg/day IV from days −6 to −3, Cy 50 mg/kg/day IV on days −2 and −1, and T cell-replete bone marrow from HLA-matched siblings (n = 79) or unrelated donors (n = 63) on day 0. GVHD prophylaxis consisted of PT/Cy 50 mg/kg/day IV on days +3 and +4. We also examined a historical control group of 15 patients treated between 2002 and 2005, who also received myeloablative conditioning with BuCy, but subsequently received CsA/MTX (15 mg/m2 IV on day 1, 10 mg/m2 IV on days 3, 6, and 11), instead of PT/Cy, for GVHD prophylaxis. Mucositis was graded on a scale from 0 to 4, where 0 connotes normal oral mucosa; 1 indicates the presence of erythema only; 2 and 3 reflect ulcerations and/or white patches covering <25% and >25% of the oral mucosa, respectively; and 4 represents hemorrhagic ulcerations. Mucositis assessments were documented daily for at least 28 days following the start of conditioning. Results: Recipients of PT/Cy experienced a significantly lower incidence of severe (grades 3–4) mucositis than did recipients of CsA/MTX (25.3% vs. 93.3%, Fisher's exact test, p < 0.001). The peak mucositis severity among recipients of PT/Cy was 2.2, compared to 3.4 for patients receiving CsA/MTX (Mann-Whitney, p < 0.0001). The mean duration of severe mucositis among PT/Cy recipients was 4.2 days. Incidences of total parenteral nutrition (TPN) use and IV narcotics administration via patient-controlled analgesia (PCA) were 8.4% and 41.5%, respectively, among patients receiving PT/Cy. The total number of days of TPN and PCA use were 9.5 and 8.7, respectively. Among patients using PCA, the average cumulative dose of IV narcotics administered was 950.1 milligrams of morphine equivalents (MME). Patients receiving PT/Cy experienced a mean maximum oral pain rating of 4.5. The 100-day cumulative incidences of grades II–IV and grades III–IV GVHD in the PT/Cy cohort were 46% and 13%, respectively. Comparative data for duration of severe mucositis, use of PCA and TPN, severity of oral pain, and cumulative incidence of GVHD in the group of patients treated with CsA/MTX is currently being collected; however, all of the mucositis-associated clinical outcomes described above compare favorably with those reported in previously published studies. Conclusions: The incidence and severity of mucositis among patients receiving myeloablative, HLA-matched BMT with high dose PT/Cy are low compared to those of historical patients treated with CsA/MTX for GVHD prophylaxis. Measures of TPN use, PCA use, oral pain, and GVHD compare favorably with previous reports. Thus, GVHD prophylaxis with high dose cyclophopshamide can significantly reduce mucositis and may impact associated clinical sequelae after transplant. Disclosures: Off Label Use: Post-transplantation cyclophosphamide for graft-versus-host disease prophylaxis. Jones:Accentia Biopharmaceuticals: Patents & Royalties. Luznik:Otsuka Pharmaceuticals: Research Funding. Fuchs:Accentia Biopharmaceuticals: Patents & Royalties.