Background and Objectives: Relapsed/refractory non-Hodgkin lymphoma (R/R NHL) remains a major therapeutic challenge, particularly in patients with peripheral T-cell lymphomas (PTCL), who frequently exhibit poor responses to salvage therapy and inferior survival outcomes. Achieving adequate disease control before autologous stem cell transplantation (ASCT) is a critical determinant of long-term survival. The bendamustine, gemcitabine, vinorelbine, and prednisolone (BEGEV) regimen has demonstrated high efficacy and favorable tolerability in relapsed/refractory classical Hodgkin lymphoma; however, data regarding its role in NHL are extremely limited. Materials and Methods: We conducted a retrospective, single-center analysis of patients with R/R NHL who received the BEGEV regimen as salvage therapy. Clinical characteristics, response rates, transplantation outcomes, progression-free survival (PFS), overall survival (OS), and safety data were evaluated. Treatment responses were assessed according to standard radiologic response criteria. Survival analyses were performed using the Kaplan-Meier method. Results: A total of 68 patients with R/R NHL were included in the analysis. Diffuse large B-cell lymphoma (DLBCL) was the predominant histological subtype, accounting for 49 patients (72.1%). BEGEV was administered predominantly in later salvage settings. Response assessments were available for 56 patients. Among evaluable patients, the objective response rate (ORR) was 73.2%, whereas the ITT ORR was 60.3% (41/68). Following BEGEV therapy, 25 patients (36.8%) proceeded to autologous stem cell transplantation (ASCT), while 8 patients (11.8%) underwent allogeneic stem cell transplantation (allo-SCT). Exploratory analyses demonstrated longer overall survival (log-rank p = 0.012) and progression-free survival (log-rank p = 0.011) among patients who subsequently underwent transplantation; however, these findings should be interpreted with caution because of the retrospective study design and the potential for selection and immortal time biases. Median PFS and OS were 4 and 26 months, respectively. Adverse events were predominantly hematologic and generally manageable. Conclusions: BEGEV may represent a reasonable salvage regimen for selected patients with R/R NHL and may facilitate disease control allowing subsequent transplantation in selected patients, including selected PTCL patients.

BACKGROUND:Allogeneic hematopoietic stem cell transplantation is a curative therapy for malignant and non-malignant hematologic disorders. Conditioning regimens, such as those based on busulfan, are utilized to promote engraftment. Busulfan-based regimens are commonly employed but exhibit significant toxicity, leading to interest in alternate drugs such as treosulfan, which may offer a superior safety profile while preserving efficacy. METHODS:This retrospective study examined 240 adult patients diagnosed with acute myeloid leukemia or acute lymphoblastic leukemia who received allogeneic hematopoietic stem cell transplantation at nine transplantation centers in Türkiye from 2010 to 2024. Patients underwent either a busulfan-based or treosulfan-based conditioning regimen. RESULTS:Engraftment was effective in both groups, with neutrophil engraftment happening earlier in the busulfan group (13 days vs. 15 days, p = 0.001). The incidence of veno-occlusive disease was significantly higher in the busulfan group (10.1 % vs. 0.9 %, p = 0.002). Cytomegalovirus infections were more prevalent in the busulfan group (51.2 % vs. 26.1 %, p < 0.001). Acute graft versus host disease occurred more frequently in the busulfan group (27.9 % vs. 18.9 %, p = 0.128); nonetheless, this difference did not reach statistical significance. No significant differences in relapse rates were detected through the groups. The overall survival was not reached in the busulfan group, while the treosulfan group demonstrated an overall survival of 40 months. CONCLUSION:Treosulfan-based conditioning regimens demonstrate similar efficacy to busulfan-based regimens while presenting a more acceptable toxicity profile. Treosulfan-based regimens also show a lower occurrence of veno-occlusive disease and cytomegalovirus infections.

Objective: To evaluate the outcomes of C-reactive protein (CRP) guided empirical antibiotic therapy versus standardized neutropenic fever approach in patients undergoing autologous stem cell transplantation. Methods: Group 1 (n=133) comprised patients who were administered triple combination antibiotic treatment when their plasma CRP levels doubled. Group 2 (n=117) composed of patients who received guideline-based triple combination antibiotic treatment only when fever was detected during neutropenia. Results: The median duration of neutropenia was 7 days in group 1 (3-18) and group 2 (4-21). The median length of hospital stay was 20 days for group 1 and 18 days for group 2, with similar durations. Fever was encountered in 64.7% of patients within group 1. The median duration of antibiotic therapy until discharge was 9 days in group 1 and 10 days in group 2, with no significant difference observed (p=0.212). One patient in group 1 died, and two patients in group 2 died due to sepsis. In patients who were diagnosed with lymphoma, the median value of the duration of antibiotic therapy until discharge was 10 days in group 1 and 14 days in group 2 (p<0.05). Conclusion: Our findings demonstrate that empirical antibiotic initiation in this patient group was not beneficial in terms of duration of hospital stay, engraftment periods, duration of antibiotic treatment, and mortality rates. While the strategy was non-inferior to the standardized approach, further research is required for risk stratification and implementation, especially in frail patients with specific diagnoses and comorbidities.

BACKGROUND:We conducted a multi-center retrospective non-randomized study to clarify roles of 2 and 3 gr/m2 doses of Cyclophosphamide (Cy) for stem cell mobilization in Multiple Myeloma. MATERIAL AND METHODS:This study analyzed 169 adult patients who received Cy-based mobilization regimen at doses 2 and 3 gr/m2 between 2018 and 2024. All patients included in this study were 18 years old and older. Patients divided into two groups; group 1 represents 2 gr/m2 treated patients, and group 2 represents 3 gr/m2 dosing. These two groups then compared in terms of CD34+ cell number collected by apheresis, apheresis days, peak peripheral blood CD34+ value and rates of mobilization failures. RESULTS:Higher doses of Cy yielded more hematopoietic stem cells compared to the lower dose Cy [10.00 (3.00-28.90) vs 9.01 (5.00-14.90), p = 0.002]; while mobilization failures and apheresis days were comparable across groups (p = 0.112 and p = 0.648, respectively). Apheresis days required for adequate stem cell harvest among groups was found statistically similar (p = 0.648). CONCLUSION:This study indicated the superior efficacy of 3 gr/m2 dose of Cy in terms of stem cell yield. However, mobilization failure and prolonged apheresis sessions were not issues with lower doses.

BACKGROUND AND OBJECTIVES:Acute leukemia patients who relapse after the first allogeneic stem-cell transplantation (HSCT1) have a poor prognosis. Second allogeneic hematopoietic stem-cell transplantation (HSCT2) is a therapeutic option for patients with acute myeloid leukemia (AML)/acute lymphoblastic leukemia (ALL) relapsing after HSCT1. Our aim is to evaluate the efficacy of HSCT2 in acute leukemia patients who relapsed after HSCT1. MATERIAL AND METHODS:In the current study, we retrospectively analyzed the data of 72 patients who underwent HSCT2. Forty-six patients with AML and 26 patients with ALL were included in the study. RESULTS:Before undergoing HSCT2, 47 % of patients were in complete remission. Median follow-up was 8 (1-109) months. Mortality at last follow-up was 61.1 %, and the median overall survival was 11 months (95 % CI: 1-22.9). Univariate analysis identified that age, Eastern Cooperative Oncology Group (ECOG), Body Mass Index, chimerism, conditioning regimen, CD34+ infused cell count, post-transplant cyclophosphamide usage, disease type, pre transplant hemoglobin-lymphocyte-lactate dehydrogenase-ferritin might be significant factors. After multivariate analysis ECOG (HR: 2.142; 95 % CI: 1.061-4.326; p = 0.034) was the only independent predictor for survival. CONCLUSION:HSCT2 remains a feasible but high-risk treatment option for patients with relapsed acute leukemia after HSCT1. Our findings confirm that ECOG performance status is a key determinant of survival despite advances in transplantation techniques.

BACKGROUND AND OBJECTIVES:Factors affecting adequate mobilization and apheresis are critical for a good yield of hematopoietic stem cells (HSCs) in the final product. A female donor, advanced age, smoking, high lactate dehydrogenase levels, high absolute lymphocyte count at baseline were found to be inversely correlated to the number of harvested CD34+ cells. However, the data on whether there is a correlation between blood types A, B, AB, O and the number of harvested CD34+ cells is insufficient. The aim of this study is to investigate the effect of blood types on the stem cell yield in healthy donors. MATERIAL AND METHODS:A total of 807 healthy donors from 10 centers in Türkiye were included in this retrospective study. Donors were subdivided into four groups as A, B, AB, O by their blood types. These four groups were compared in terms of age, sex, ECOG performance score, smoking status, and the amount of harvested CD34+ stem cells. RESULTS:The median age of the 807 healthy donors included in the study was 35 years (11-70). 256 (31.7 %) donors were female and 551 (68.2 %) donors were male. There were 349 donors in type A blood group, 134 in type B blood group, 53 in type AB blood group and 271 donors in type O blood group. The median amount of CD34+ cells in the total apheresis product was 7.67 × 106 per kg in type O blood group, 7.52 × 106 per kg in type A blood group, 7.2 × 106 per kg in type B blood group, and 7.45 × 106 per kg in type AB blood group. There was no statistically significant difference among the groups (p:0.673). Smoking was lower in the type B blood group with 29.1 % compared to the other groups. However, there was no statistically significant difference in total amount of CD34+ stem cells in the type B blood group who smoked less (p = 0.949). CONCLUSION:In our study in which we have retrospectively analyzed the effect of donor blood types on the efficiency of HSCs harvested from peripheral blood in healthy donors, no correlation was found between the blood types and the mobilization and amount of harvested CD34+ cells.

In multiple myeloma, plasma cells can display intracellular and intranuclear inclusions. This case report highlights the coexistence of basophilic Snapper-Schneid granules and Auer rod-like cytoplasmic inclusions. A 73-year-old female patient, with a history of hyperlipidemia, rheumatoid arthritis, and hypertension, presented with swelling in both upper extremities. Subsequent evaluations revealed significant proteinuria, hypercalcemia, and atypical plasma cells characteristic of multiple myeloma, with both Auer rod-like inclusions and Snapper-Schneid granules observed. Auer rod-like inclusion bodies are particularly observed in patients with kappa light-chain-type multiple myeloma. The positivity of these bodies for alpha-N-esterase, acid phosphatase, and beta-glucuronidase suggests they are of lysosomal origin. However, the prognostic implications of Auer rod-like inclusions and Snapper-Schneid granules in multiple myeloma remain unclear. Snapper-Schneid granules, described as oval basophilic granules, are associated with immunoglobulin but are not found exclusively in multiple myeloma.

In REACH3 (ClinicalTrials.gov identifier: NCT03112603), ruxolitinib was investigated versus best available therapy (BAT) for 3 years in patients with steroid-refractory/dependent chronic graft-versus-host-disease (SR/D-cGVHD). Patients received ruxolitinib (10 mg twice daily) or BAT for 24 weeks; thereafter (weeks 24-156), patients continued randomized treatment, entered long-term survival follow-up, or crossed over from BAT to ruxolitinib. In 329 randomly assigned patients (ruxolitinib: 165; BAT: 164), the median failure-free survival (FFS) was 38.4 months for ruxolitinib versus 5.7 months for BAT (hazard ratio, 0.36 [95% CI, 0.27 to 0.49]). Median duration of response (DOR) was not reached for ruxolitinib versus 6.4 months for BAT. Ruxolitinib-treated patients had a higher probability of FFS (ruxolitinib: 56.5%; BAT: 18.2%) and maintaining a response (ruxolitinib: 59.6%; BAT: 26.7%) at 36 months. Median overall survival was not reached. Nonrelapse mortality and malignancy relapse/recurrence events were low. In 70 patients who crossed over to ruxolitinib, the overall response rate (50.0%) at week 24 and best overall response (81.4%) during the crossover period were consistent with the primary analysis of randomly assigned patients. No new safety signals were observed. Ruxolitinib provided longer FFS and DOR than BAT, demonstrating sustained efficacy and manageable safety over 3 years of follow-up in patients with SR/D-cGVHD.

Myeloid sarcoma (MS) is a rare tumor characterized by the extramedullary proliferation of immature granulocytic cells. It can occur as a primary disease or as a manifestation of acute myeloid leukemia, with an incidence of three to five percent in patients diagnosed with the condition. This report presents a thirty-seven-year-old female patient with acute monoblastic leukemia (French-American-British classification, subtype M5) who achieved complete remission after induction therapy, and allogeneic bone marrow transplantation. Six-teen months after achieving remission, the patient experienced a relapse in the pituitary gland, which was initially misdiagnosed as a pituitary adenoma. Following gross total surgical resection, the diagnosis of MS was confirmed. Adjuvant craniospinal radiotherapy and systemic therapy with azacitidine and venetoclax led to sustained remission without further complications. This case highlights the diagnostic and therapeutic challenges of MS, particularly in its rare presentation involving the pituitary gland. Radiotherapy, in combination with systemic treatment, played a crucial role in the management of this relapse. The findings emphasize the importance of a multidisciplinary approach in managing rare cases of MS to optimize patient outcomes.

Aim: This study aimed to assess the real-world performance of elranatamab in terms of its effectiveness, safety, and tolerability among patients diagnosed with triple-class refractory-multiple myeloma (TCR-MM) who have undergone extensive prior treatment. Methods: A retrospective review was conducted at a single medical center, involving 12 TCR-MM patients who received elranatamab. Data were analyzed on demographics, cytogenetics, disease burden, prior therapies, infectious complications, and survival outcomes. Responses were assessed according to International Myeloma Working Group criteria, and adverse events were graded per common terminology criteria for adverse events version 5.0. Results: The overall response rate was 83.3%, with a median progression-free survival of 8.0 months and a median overall survival of 11.0 months. Common adverse events included grade ≥3 infections (75%) and cytokine release syndrome (CRS), which occurred in 41.7% of the participants, with only grade 1-2 CRS observed. No immune effector cell-associated neurotoxicity syndrome was reported. Conclusion: Elranatamab demonstrated promising clinical efficacy and an acceptable safety profile in a heavily pretreated TCR-MM population. The elevated risk of infections necessitates close clinical surveillance.

OBJECTIVES:Hematopoietic stem cell transplantation is an important treatment for many benign and malignant diseases. Factors affecting the donor response to mobilization and thus hematopoietic progenitor cell yield have been investigated, but studies on donor body mass index are limited and contradictory. Our aim in our study was to investigate this situation. MATERIAL AND METHODS:The data of a total of 665 healthy donors were analyzed and divided into 2 groups as body mass index (BMI) < 25 (group 1, n: 247) and ≥ 25 kg/m2 (group 2, n: 418). In addition to demographic data, smoking, blood group, agent used for mobilization, number of days of apheresis, volume of blood processed, amount of product collected, complete blood count before mobilization and biochemical parameters were evaluated. RESULTS:Group 1 consisted of 247 and group 2 consisted of 418 participants. Median age was 29 (18-66) years in group 1 and 37 (18-68) years in group 2. Median BMI was 22.49 (16.10-24.98) and 28.06 (25.00-48.27) kg/m², respectively. Male donors constituted 62.7 % in group 1 and 73.9 % in group 2. In group 2, the number of apheresis days was lower and the median CD34+ stem cell count on the first day and in total was statistically significantly higher (7.1 ×106/kg and 7.58 ×106/kg, respectively). CONCLUSION:In healthy donors, CD34+ stem cells were correlated with BMI, whereas no statistically significant difference was found between the groups in terms of smoking habit, blood group, granulocyte stimulating agent type, processed blood volume, non-lymphocyte and biochemical parameters other than LDH.

BackgroundThe optimal goal in the management of refractory/relapsed classical Hodgkin lymphoma (R/R-cHL) is to obtain minimal disease status before stem cell transplantation (SCT). The efficiency of BEGEV (bendamustin, gemcitabine, vinorelbine) regimen is well-established as first-line salvage therapy in earlier studies. The search for novel treatment continues for patients with limited options in later lines. This study aimed to evaluate the efficacy of BEGEV regimen in heavily pretreated, platinum-resistant, R/R-cHL.MethodsIn this single-center retrospective trial, patients diagnosed with R/R-cHL between 2018 and 2023 were analyzed. Patients who received BEGEV in third- or fourth-line treatment were eligible. Patient's demographic characteristics, pathology results, treatment and survival outcomes were recorded. Overall survival (OS), objective response rate (ORR), progression free survival (PFS) and toxicity were analyzed.ResultsA total of 31 patients were included in this study. 27 (87.2%) patients were treated with BEGEV in the 3rd line and 4 (12.8%) patients were treated in the 4th line. The results show an ORR of 90.3%, with 54.9% achieving complete response. The median PFS and OS after the BEGEV regimen was 20.2 (range 15-23.6) and 23.2 (range 15.4-40.8) months, respectively. The regimen demonstrated acceptable toxicity, with the most common severe adverse events being neutropenia and thrombocytopenia. SCT was successfully performed in 100% of the patients after BEGEV treatment.ConclusionOur findings suggest that BEGEV is a viable and effective treatment option for heavily pretreated, platinum-resistant R/R-cHL patients, particularly in regions with limited access to novel therapies.

Bacgroun/Purpose: The aim of this study was to investigate the safety, difference in duration of engraftment and relapse rates between autologous transplant patients who had their stem cell infusions during a single day or multiple days. Methods: In this retrospective study the clinical data of 77 ASCT patients from a single center,30 of whom were transplanted in fractionated infusions were investigated. Duration of engraftment, side effects during the transplant, PFS and OS data of the two groups was compared. Results: There was no statistical difference between single day and fractionated infusion patients regarding neutrophil engraftment, toxic side effects, PFS, OS and relapse rate at 18 months. Platelet engraftment was delayed for one day in the fractionated group, which did not cause prolonged hospitalization. The transplant patients who had multiple day infusion had similar engraftment duration despite their lower average CD34+ cell counts. Conclusion: Fractionated infusions lead to similar engraftment duration to single day infusion for ASCT. The higher CFU cell number seen in the poorly mobilized patients may have a key role in the adequate engraftment. The fractionated infusion approach for such patients was feasible, safe and no increase of the disease relapse was observed with this procedure.

AbstractIntroductionType of conditioning regimen impacts the outcome of patients who undergo allogeneic HSCT since graft versus host disease (GVHD), infections, regimen related toxicities (RRT) are important causes of post‐transplant mortality. Despite the RRT profile of busulfan, it is frequently used worldwide. Treosulfan has advantages in terms of dose of administration, lower incidence of sinusoidal obstruction syndrome and lower neurotoxicity. We retrospectively investigated outcomes of patients who underwent allogeneic HSCT with treosulfan or busulfan based conditioning regimens in our institution.MethodsTreosulfan was administered to 94 patients while 85 patients received busulfan. Our outcomes were RRT, chronic and acute GVHD, relapse related mortality (RRM), non‐relapse mortality, and fungal infection. The clinical follow up data, regarding the primary and secondary endpoints of our study, of the patients who received treosulfan or busulfan based conditioning regimens were statistically analyzed.ResultsThe median follow‐up was 14 months for the treosulfan group while it was 11 months for the busulfan group (p = 0.16). RRT was 11.7% and 7.1% for treosulfan and busulfan respectively. The incidence of extensive chronic GVHD was less frequent in the treosulfan group compared to the busulfan group (15.7% vs. 32.1%) (p < 0.001). The incidence of acute GVHD (Grade 3 or higher) was 32.2% in the treosulfan group while it was 31.6% in the busulfan group. The RRM was 17% in the treosulfan group while it was 34% in the busulfan group. The non‐relapse mortality was 35.5% and 29.4% in the treosulfan group and in the busulfan group respectively (p = 0.962).ConclusionTreosulfan, with a lower RRM, lower chronic GVHD incidence and with a similar RRT profile appears to be a safe alternative to busulfan.

This case report aims to highlight the importance of close oral monitoring before and during chemotherapy in patients with B-cell acute lymphoblastic leukemia (B-ALL) to prevent medication-related osteonecrosis of the jaw (MRONJ). A 22-year-old male patient diagnosed with B-ALL who developed MRONJ during chemotherapy, despite not receiving bisphosphonates or denosumab, was presented. The patient's medical history, treatment regimen, clinical examination findings, and treatment outcomes were reported. The patient developed maxillofacial cellulitis during chemotherapy, leading to a diagnosis of stage 3 MRONJ. Conservative treatment was initiated, resulting in the reversion of the disease to stage 1 and stabilization of the progression. The patient achieved remission and underwent prophylactic cranial radiotherapy. This case report presents a unique case of MRONJ in a young patient without prior use of antiresorptive agents or denosumab. It highlights the need for close oral monitoring in patients with B-ALL before and during chemotherapy, as MRONJ can develop in the absence of these medications.

Introduction: BK virus associated hemorrhagic cystitis(BKV-AHC) is a serious complication observed after allo-geneic stem cell transplantation and the current therapeutic options are scarce with substantial renal side effects. Although the guidelines recommend intravenous cidofovir application with caution to nephrotoxicity, there are few studies which investigated intravesical administration and reported similar therapeutic results with less renal side effects. Methods: We administered low dose, daily and consecutive (75 mg/day, for 5 days) intravesical cidofovir to 25 patients with BKV-AHC that developed after (ASCT). Results: The response rate in our cohort was 92% and relapse was not encountered in 84% of the patient population during one year of follow-up. The median BK urine viral load significantly decreased from 260,000,000 IU/mL to 53,000,000 IU/mL after a week of treatment (p = 0.0001). Rise in serum creatinine was observed in 5 patients during treatment and post-treatment nephrotoxicity was seen in only 1 patient. Conclusions: Daily low dose intravesical cidofovir might be an effective treatment option for BKV-AHC after ASCT with favorable less systemic side effects.

Introduction: Corticosteroids (CS) are the standard first-line treatment for patients (pts) with chronic graft-versus-host disease (cGvHD), but pts can be unresponsive or become refractory to or dependent on CS (SR/D).Ruxolitinib (RUX), a JAK1/2 inhibitor, is approved for the treatment of pts ≥12 years of age with SR/D-cGVHD, based on the primary outcomes from the randomized, phase III REACH3 (NCT03112603) study, which demonstrated the superior efficacy of RUX vs best available treatment (BAT) in pts with SR/D-cGVHD. Here, we present the final, long-term efficacy and safety outcomes from REACH3. Methods: Pts ≥12 years of age with moderate or severe SR/D-cGVHD were randomized 1:1 to receive either RUX 10 mg twice daily (BID) or investigator-selected BAT and followed for 3 years, till discontinuation or death. The primary analysis was conducted at week 24 (Cycle 7 Day 1 [C7D1]) in randomized pts, then pts entered the extension period (C7-39) in which they continued treatment, switched from BAT to RUX (crossover cohort), or discontinued treatment and entered long-term survival follow-up (FU). Failure-free survival (FFS; key secondary endpoint), duration of response (DOR), overall survival (OS), non-relapse mortality (NRM), malignancy relapse (MR), and safety were analyzed at 3 years (week 156; final data cut off 15 Dec 2022). Overall response rate (ORR) and best overall response (BOR) during the crossover treatment period were analyzed for pts who switched from BAT to RUX on or after C7D1. Results: Of 329 pts randomized, 53 completed the treatment period and 276 discontinued, 115 entered survival FU (RUX: 73/165; BAT:42/164); 70 pts crossed over from BAT to RUX of which 16 completed the crossover treatment period and 24 entered survival FU. Median FFS was longer in the RUX vs BAT arms (38.4 vs 5.7 months; hazard ratio [HR]=0.361, 95% confidence interval [CI]: 0.268, 0.485) with 12-month FFS probabilities of 64.0% (95% CI: 56.1, 70.8) and 28.8% (95% CI: 21.8, 36.1), respectively. Median OS was not reached and there was no difference in risk of death between the arms (HR=0.851, 95% CI: 0.544, 1.331) [Table 1]. Median DOR was 6.4 months (95% CI: 4.9, 11.4) in the BAT arm but was not reached for the RUX arm; notably, the probability of maintaining DOR at 3 years was higher in RUX (59.6%; 95% CI: 50.4, 67.6) vs BAT (26.7%; 95% CI: 18.5, 35.5). NRM event rates were similar between the arms (RUX: 29/165; BAT 34/164), and MR events were similar and low in both arms (13/156 and 11/160, RUX and BAT respectively) up to 3 years. The ORR at week 24 after crossover from BAT to RUX was 50.0% (95% CI: 37.8, 62.2), including complete response (CR) in 4 (5.7%) pts and partial response (PR) in 31 (44.3%) pts. The BOR during crossover was 81.4% (95% CI: 70.3, 89.7), including CR of 7.1% and PR of 74.3%; disease progression only occurred in 1 pt. Almost all pts treated during the main treatment period (RUX: 100%; BAT: 93.7%) experienced ≥1 adverse event (AE) and, in general, AE rates were higher in the RUX vs BAT arms [Table 2], likely due to prolonged FU and exposure to RUX (median exposure to treatment of 52.9 weeks vs. 24.1 weeks for RUX and BAT, respectively).Anemia was the most common AE (RUX: 33.9%; BAT: 15.8%) and grade ≥3 AE for RUX (17.6% vs BAT 9.5%, respectively); grade ≥3 neutropenia, thrombocytopenia, alanine aminotransferase increase, and gamma-glutamyltransferase increase were also ≥5% higher for RUX than BAT. Anemia (24.2%; grade ≥3, 10.3%) and thrombocytopenia (3.8%) were the most common RUX and BAT treatment-related AEs, respectively. Infections, excluding tuberculosis, were the most common AE of special interest (77.6% vs. 68.4%; grade ≥3, 31.5% and 26.6%, for RUX and BAT, respectively). On-treatment deaths were mainly due to cGvHD (n/N, RUX: 10/18; BAT 6/12). Conclusions: After 3 years of treatment in REACH3, the longer FFS and higher DOR with RUX vs BAT indicated that cGVHD was more in control with RUX treatment. Notably, efficacy was demonstrated in pts who switched from BAT to RUX with an ORR similar to that in pts randomized to RUX. RUX was well tolerated with no unexpected toxicities and safety that was consistent with earlier studies. Overall, the long-term control of cGVHD and tolerability of RUX was demonstrated for pts ≥12 years of age with SR/D-cGvHD.