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Öğe A new hope in the treatment of steroid-refractory graft versus host disease (Sr-GVHD) after allogeneic hematopoetic stem cell transplantation (AHSCT): Ruxolitinib(Springer Nature, 2020) İlhan, Osman; Cengiz Seval, Güldane; Civriz Bozdağ, Sinem; Deveci, Burak; Pehlivan, Mustafa; Kaynar, Leylagül; Yavaşoğlu, İrfan; Beköz, Hüseyin Saffet; Yönal Hindilerden, İpek; Yeğin, Zeynep Arzu; Dağdaş, Simten; Avşar, Ayşe; Özkan, Atilla Hasan; Fırat Tuğlular, Tülin; Göker, Hakan; Gülbaş, Zafer[Abstract Not Available]Öğe Gilteritinib (XOSPATA (R)) in Turkey: Early access program results(Mattioli 1885, 2023) Doğu, Mehmet Hilmi; Tekgündüz, Ali İrfan Emre; Deveci, Burak; Korkmaz, Gülten; Cömert, Melda; Sevindik, Ömür Gökmen; Yokuş, Osman; Serin, İstemiBackground And Objectives: Gilteritinib (XOSPATA (R), Astellas) is a type I oral FLT3 inhibitor, a tyrosine kinase AXL inhibitor, involved in both c-Kit and FMS-like tyrosine kinase 3 (FLT3) resistance. In the phase 3 ADMIRAL trial, gilteritinib was compared with the standard of care in (R/R) acute myeloid leukemia (AML) patients who harbored any FLT3 mutation and showed superior efficacy with regard to response and survival. Objectives: This research aimed to investigate the real-life efficacy and safety of gilteritinib in FLT3-positive R/R AML patients who were treated as a part of an early access program held in Turkey in April 2020 (NCT03409081). Results: The research included 17 R/R AML patients who had received gilteritinib from seven centers. The overall response rate was 100%. The most common adverse events were anemia and hypokalemia (7 patients, 41.2%). Grade 4 thrombocytopenia was observed in one patient only (5.9%), leading to permanent treatment discontinuation. Patients with peripheral edema had a 10.47 (95% CI: 1.64-66.82) times higher risk of death than those without peripheral edema (p<0.05). Conclusion: This research showed that patients with febrile neutropenia and peripheral edema were at a high risk of death when compared to patients without febrile neutropenia and peripheral edema.Öğe Glofitamab in relapsed/refractory diffuse large B cell lymphoma: Real world data(American Society of Hematology, 2022) Ferhanoğlu, Burhan; Gülbaş, Zafer; Uzay, Ant; Özcan, Muhit; Özkalemkaş, Fahir; Dal, Mehmet Sinan; Kalyon, Hakan; Akay, Olga Meltem; Deveci, Burak; Bekoz, Hüseyin; Sevindik, Ömür Gökmen; Toptaş, Tayfur; Yılmaz, Asu Fergün; Koyun, Derya; Alkış, Nihan; Birtaş Ateşoğlu, ElifAbstract INTRODUCT ?ION Glofitamab is a T-cell-engaging bispecific antibody connecting CD20 on B cells and CD3 on T cells. Although, most of the patients with B-cell non-Hodgkin lymphoma (BNHL) achieve complete response (CR) following firstline treatment with rituximab and chemotherapy, about 40% of patients with diffuse large B-cell lymphoma (DLBCL) is refractory or relapse (R/R). Autologous stem-cell transplantation (ASCT) can cure some of these patients but many patients cannot undergo this procedure. CAR-T therapies are a significant advance but not available in many countries like Turkey. In Phase II expansion study, the overall response rate (ORR) was 51.6% and complete remission (CR) rate was 39.4% in R/R DLBCL patients (Dickinson er al. JCO 2022). In this retrospective study, we aimed to report the outcomes of patients who used glofitamab via compessionate use in Turkey.Öğe Ibrutinib as a promising treatment for pulmonary complications due to refractory chronic graft versus host disease(Elsevier Science Inc, 2020) İlhan, Osman; Cengiz Seval, Güldane; Uzay, Ant; Kaya, Emin; Öztürk, Zübeyde Nur; Deveci, Burak; Yavaşoğlu, İrfan; Ural, Ali Uğur; Beköz, Hüseyin Saffet; Ayli, Meltem; Sevindik, Ömür Gökmen; Civriz Bozdağ, Sinem; Kurt Yüksel, Meltem; Gülbas, ZaferIntroduction: Despite major improvements in allogeneic hematopoetic stem cell transplantation form matched related/ unrelated donor over last decades, chronic graft-versus-host disease (cGVHD) is still the leading cause of late treatmentrelated deaths among recipients. Ibrutinib is a first class inhibitor of BTK was recently employed in corticosteroid-refractory chronic GVHD with encouraging overall response rates Herein, we share a real-life experience using ibrutinib in the treatment of steroid-refractory cGVHD. Patients and Methods This multicenter retrospective study conducted in 10 different stem cell transplant centers included 44 adult patients diagnosed with steroid-refractory cGVHD. We treated off-label these patients from June 2017 to July 2019 with ibrutinib with a dose of 420 mg. Organ sites affected and cGVHD grading were classified according to the NIH 2014 criteria. Results Patients had undergone both myeloablative and non-myeloablative Allo-SCT for a variety of underlying hematological malignancies. As expected mouth and skin were the most frequently involved organs and 67 % of patients showed evidence of cGVHD in more than two organs. The median Karnofsky Performance Status score was 65%. At a median follow-up of 22.3 months (range 7.1-109 months) after evidence of cGVHD showed, 36 (81.8%) patients were still receiving ibrutinib and 4 (9.1%) had discontinued treatment, because of cGVHD progression. Treatment duration ranged from 2 to 12 months (median 6 months) for all patients. Only three patients had grade 2 muscle spasm, arrhythmia and diarrhea as adverse events and need to reduce the 25% of drug dosage. No several adverse events due to ibrutinib were observed in our cohort. In the all treated population, based on the 2005 NIH cGVHD Consensus Panel response criteria, 45.5% PR and 20.5% CR were achieved. Six patients had progression on manifestations of cGVHD. For the responders, the median time to initial response was 28 days. Nine patients had stable disease under the ibrutinib treatment and still continue receiving. Analysis by organ domain showed similar rates of response in the lung (76.4%) skin (66.7%), and GIS (57.1%). However the response in the liver (54.2%) was lower than the others. Out of 17 patients with bronchiolitis obliterans as a manifestation of cGVHD, we observed an immediate improvement in stability of FEV1 decline that persisted over the study period despite the decreased steroid dosing in 13 patients, 3 patients had stable FEV1 and only 1 patient had reduction in FEV1. Discussion Our study suggests that ibrutinib is a safe and effective agent that reduces steroid requirements and stabilizes lung function in patients with bronchiolitis obliterans as a manifestation of cGVHD. Our study adds to a growing body of evidence for ibrutinib's use in cGVHD. It is important to note that, larger prospective studies are needed to verify and augment our findings.Öğe Polatuzumab vedotin, rituximab, and bendamustine combination in relapsed or refractory diffuse large B-cell lymphoma: A real-world data from Turkey(Springer, 2023) Dal, Mehmet Sinan; Ulu, Bahar Uncu; Uzay, Ant; Akay, Olga Meltem; Beşışık, Sevgi; Yenerel, Mustafa Nuri; Çelik, Serhat; Kaynar, Leylagül; Yücel, Orhan Kemal; Deveci, Burak; Sönmez, Mehmet; Mehtap, Özgür; Beköz, Hüseyin Saffet; Sunu, Cenk; Salim, Ozan; Ulaş, Turgay; Kartı, Sami; Altuntaş, Fevzi; Ferhanoğlu, Burhan; Tuğlular, Tülin FıratPolatuzumab vedotin (Pola) with bendamustine and rituximab (BR) is a promising option for patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). We analyzed the data of 71 R/R DLBCL patients who had been treated with Pola-BR in the named patient program from March 2018 to April 2021 from 32 centers in Turkey. All patients received up to six cycles of Pola 1.8 mg/kg, rituximab 375 mg/m2 on day 1, and bendamustine 90 mg/m2 on days 1–2 of each cycle. Median age at Pola-BR initiation was 55 (19–84). The overall response rate was 47.9%, including 32.4% CR rate when a median of 3 cycles was applied. With a median follow-up of 5 months, the median OS was 5 months. Grade 3–4 neutropenia and thrombocytopenia were the most common hematological toxicities. The real-world data from our cohort showed the Pola-BR is an effective option with a manageable toxicity profile.Öğe Safety and efficacy of mesenchymal stromal cell therapy for multi-drug-resistant acute and late-acute graft-versus-host disease following allogeneic hematopoietic stem cell transplantation(Springer, 2023) Keklik, Muzaffer; Deveci, Burak; Çelik, Serhat; Deniz, Kemal; Gönen, Zeynep Burçin; Zararsız, Gökmen; Saba, Rabin; Ünal, AliGraft versus host disease (GvHD) remains a significant risk for mortality and morbidity following allogeneic hematopoietic stem cell transplantation (HSCT). A growing literature supports successful applications of mesenchymal stromal cells (MSCs) for the treatment of steroid-refractory acute GvHD (aGvHD). However, there is limited knowledge about the effects of MSC treatment on late-acute GvHD (late aGvHD). In this article, we present our multicenter study on the safety and efficacy of MSC therapy for patients with steroid-refractory late aGvHD in comparison to those with aGvHD. The outcome measures include non-relapse mortality (NRM) and survival probability over a 2-year follow-up. The study includes a total of 76 patients with grades III-IV aGvHD (n = 46) or late aGvHD (n = 30), who had been treated with at least two lines of steroid-containing immunosuppressive therapy. Patients received weekly adipose or umbilical cord-derived MSC infusions at a dose of median 1.55 (ranging from 0.84 to 2.56) x 10(6)/kg in the aGvHD group, and 1.64 (ranging from 0.85 to 2.58) x 10(6)/kg in the late aGvHD group. This was an add-on treatment to ongoing conventional pharmaceutical management. In the aGvHD group, 23 patients received one or two infusions, 20 patients had 3-4, and three had >= 5. Likewise, in the late aGvHD group, 20 patients received one or two infusions, nine patients had 3-4, and one had >= 5. MSC was safe without acute or late adverse effects in 76 patients receiving over 190 infusions. In aGvHD group, 10.9% of the patients had a complete response (CR), 23.9% had a partial response (PR), and 65.2% had no response (NR). On the other hand, in the late aGvHD group, 23.3% of the patients had CR, 36.7% had PR, and the remaining 40% had NR. These findings were statistically significant (p = 0.031). Also, at the 2-year follow-up, the cumulative incidence of NRM was significantly lower in patients with late aGvHD than in patients with aGvHD at 40% (95% CI, 25-62%) versus 71% (95% CI, 59-86%), respectively (p = 0.032). In addition, the probability of survival at 2 years was significantly higher in patients with late aGvHD than in the aGvHD group at 59% (95% CI, 37-74%) versus 28% (95% CI, 13-40%), respectively (p = 0.002). To our knowledge, our study is the first to compare the safety and efficacy of MSC infusion(s) for the treatment of steroid-resistant late aGVHD and aGVHD. There were no infusion-related adverse effects in either group. The response rate to MSC therapy was significantly higher in the late aGvHD group than in the aGvHD group. In addition, at the 2-year follow-up, the survival and NRM rates were more favorable in patients with late aGVHD than in those with aGVHD. Thus, the results are encouraging and warrant further studies to optimize MSC-based treatment for late aGVHD.
