3498 Introduction: Oral mucositis is a complication of conditioning treatment that produces pain and morbidity in allogeneic hematopoietic stem cell transplant (allo-HSCT) recipients. The rationale of this study was to evaluate the efficacy of a calcium phosphate mouth rinse (Caphosol) vs standard regimen in 40 adult patients undergoing allo-HSCT. Patients and Methods: 40 patients treated with allo-HSCT (31 from unrelated donors, 9 from siblings) performed in Hematology and BMT center in Katowice in 2009 were randomized and stratified by the conditioning regimen (busulfan-, treosulfan- or TBI- based), type of transplant (unrelated or related) and age into two equal groups. Treatment group received Caphosol washes 4 times daily from first day of conditioning until reaching ANC 0.2 G/l. Control group received standard topical mouth care with salvia, antibacterial and antifungal solutions. During the trial patients subjectively assessed level of pain in mouth and in pharynx using 0–10 scale and swallowing problems using 0–5 scale. Mucositis was judged by experienced physician. Nonparametric Mann-Whitney U-tests were used for statistical analysis. Results: Average oral toxicity in WHO scale in Caphosol vs control group was 0.9 vs 1.8 (p=0.02), duration of mucositis was 3.2 vs 7.1 days (p=0.02). Total parenteral nutrition (TPN) due to mucosits was required in Caphosol vs control group in 0 vs 6 pts, average duration of TPN was 0 vs 1.9 days (p=0.009). Analgetics were required, respectively, in 3 vs 9 pts and analgesy lasted for 1.1 vs 3.4 days (p=0.047). Average subjective peak pain in mouth was 0.85 vs 1.75 (p=0.005) and in pharynx 1.95 vs 2.2 (NS) in Caphosol vs control group, average pain intensity was lower in Caphosol group throughout the whole period of mucositis. Intensity of swallowing problems tended to be lower in Caphosol group (NS). Acute GVHD was observed in 7 vs 9 pts in Caphosol vs control group and its average degree was 0.5 vs 0.9 (NS). Conclusions: Caphosol mouth rinse in the allo-HSCT recipients is associated with decrease of oral toxicity, lower peak pain due to mucositis and its shorter duration. In consequence, comfort of life is improved and the incidence of acute GVHD is reduced, as well as the requirement of TPN and analgetics. Disclosures: No relevant conflicts of interest to declare.
Objective: Oral mucositis occurs in 75% to 100% of allogeneic HSCT recipients can cause pain, facilitate infections, delay discharge, and threaten life. The aim of the study was to evaluate prophylaxis with the remineralizing mouthwash solution of supersaturated calcium phosphate rinse (SCPR) with Fomukal on measures of severity of mucositis and consequent interventions and complications, in comparison to Caphosol, already evaluated post-transplant. Materials/Methods: In this prospective, randomized, non-inferiority trial, 46 patients undergoing allogeneic HSCT were equally randomized to Fomukal or Caphosol, each administered four times daily from initiation of conditioning until the granulocyte count ≥0.2 G/L. Hematologist measured the daily severity of mucositis according to a WHO scale and patients self-assessed its symptoms. Need for analgesics, anti-infectious drugs, total parenteral nutrition (TPN) and incidence of complications were also assessed. Results: Fomukal vs. Caphosol groups had the same all following indicators: median measures of WHO oral mucositis reduction (0 vs. 2; P = NS), length of disease course (0 vs. 6 days; P = NS), peak and mean mouth (1 vs. 2; P = NS and 0.06 vs. 1; P = NS) and throat pain (1 vs. 1; P = NS and 0.22 vs. 0.31; P = NS), and peak and mean swallowing problems (1 vs. 1; P = NS and 0.19 vs. 0.25; P = NS). Analgesics need (7 vs. 10 patients; 0 vs. 0 days; P = NS) and the need for antifungals (1 vs. 2 drugs; P = NS) were not different, while the need for antibiotics and antivirals (3.5 vs. 5 drugs; P = 0.011 and 1 vs. 2 drugs; P = 0.023) were lower in the Fomukal group. Measures of complications: infections (7 vs. 12 patients, P = NS) and a GVHD (13 vs. 14 patients, P = NS, grade 1 vs. 1, P = NS) did not differ. Discussion: Both SCPR mouth rinses, Fomukal and Caphosol, were associated with similar effectiveness in reducing severity of oral mucositis.
Factors contributing to relapses and GVHD following allogeneic Hematopoietic Stem Cell Transplantations (HSCT) from HLA-matched unrelated donors are not well established. We analyzed 35 patients (pts) transplanted from HLA 10/10 alleles (A, B, C, DRB1, DQB1) matched unrelated donors (URD) in the Dept. of Hematology and BMT, Katowice, Poland, with use of the same standard operating procedure from January 2004 until March 2006. Indication for HSCT was AML (13 pts), ALL (8), CML (7), MDS (2), PNH (3), CLL (1), myeloid sarcoma (1). Preparative regimen was Treosulfan+Fludarabine (23 pts), TBI+Cy (9) and Bu+Cy (3). Alleles encoding 11 minor Histocompatibility Antigens (mHA: HA-1, HA-2, HA-3, HA-8, HB-1, ACC-1, ACC-2, HwA-9, HwA-10, UGT2B17, HY) were analyzed for each donor-recipient pair with use of Dynal AllSet mHA typing kit and PCR-SSP method. Only immunogenic mHA mismatches were analyzed. Information on whether mHA mismatches might result in Host-versus-Graft or Graft-versus-Host responses was established with use of the minor Histocompatibility Knowledge Database of Leiden University Medical Center’s minor Histocompatibility Workshop. Patients transplanted from donors with mHA mismatched in HVG direction had significantly higher probability of relapse (64+/− 8% versus 10+/− 9%, p=0.003) when compared to pairs without mHA HVG immonogenicity. Patients transplanted from donors with mHA mismatched in GVH direction had higher probability of aGVHD (88+/− 8% versus 53+/− 11%, p=0.14) and cGVHD (41+/− 16% versus 37+/− 17%, p=0.65) when compared to pairs without GVH immunogenicity. GVHD was also observed more often on day +100 (33% versus 6%, p=0.06) when mHA mismatch in GVH direction was present. Observed influence of HVG and GVH immonogenicity on probability of relapse and GVHD did not lead to significantly different survival in observed groups of pts. These results indicate that mHA immunogenic mismatches in HVG and GVH direction may be responsible for relapse and GVHD, respectively, in HSCT recipients from HLA-matched unrelated donors. The study is being continued to confirm these primary observations and to establish the associations of specific mHA mismatches with HSCT outcomes. Impact of mHA mismatch on probability of relapse and GVHD Immunogenicity of mHA mismatches HVG no HVG p # of patients 18 17 Relapse at 1 year 64%+/−8 10%+/−9 0.003 Immunogenicity of mHA mismatches GVH no GVH p # of patients 16 19 aGVHD 88%+/− 8 53%+/−11 0.14 cGVHD at 1 year 41%+/−16 37%+/−17 0.65 Impact of mHA mismatch on probability of survival Immunogenicity of mHA mismatches HVG GVH only HVG only GVH no HVG no GVH p # of patients 9 9 7 10 Survival at 9 months 63%+/−17 57%+/−25 83%+/−15 69%+/−15 0.86
Introduction Failure to respond to steroid therapy for intestinal acute graft-versus-host disease (aGvHD) is associated with limited further therapeutic options. Fecal microbiotherapy is defined as the perfusion of treated stool from one or several healthy donors via the upper or lower gastrointestinal (GI) route aiming at improving microbial diversity and functionality. Here we report clinical outcomes from a 76-patient cohort with steroid refractory (SR) GI-aGvHD treated with the pooled allogenic fecal microbiotherapeutic MaaT013. Twenty-four patients were treated in the prospective, single-arm, phase IIa, HERACLES study (NCT03359980) while 52 patients were treated in an expanded access program (EAP). Patients and methods For HERACLES, 24 patients with grade III-IV SR-GI-aGvHD were treated with MaaT013 in 26 European sites, as a 2 nd line therapy after SR diagnosis and evaluable for treatment response. In EAP, 52 patients with steroid-dependent or SR-GI-aGvHD (classical n=41, late onset n=3, overlap syndrome n=8) were treated. These patients had previously received and failed 1 to 6 lines (median 3; 40/52 received ruxolitinib) of GvHD systemic treatments. GI-GvHD response was evaluated weekly and 28 days after day (D) 0 (inclusion for HERACLES or 1st dose for EAP). For all patients, GI-overall response rate (ORR) at D28 was defined as the proportion of patients achieving complete response (CR), very good partial response (VGPR) or partial response (PR), compared to D0, without the use of additional systemic therapy. Other endpoints included the best overall response (BOR) achieved at any time, and overall survival (OS). Prepared under GMP, MaaT013 is characterized by a highly consistent richness of 455 ±3% OTUs and an Inverse Simpson index > 20. Treatment comprised 3 MaaT013 doses, each composed of 30 g of feces in 150 mL volume of inoculum (total 90 g of feces from 4 to 8 healthy donors) administered by enema (except for 2 EAP patients by nasogastric tube). All patients received at least 1 MaaT013 dose, 92% (HERACLES) and 87% (EAP) at least 2 doses, and 50% (HERACLES) and 71% (EAP) the full treatment course. In HERACLES, the reasons for not applying the 3 rd dose were death (n=5), physician decision to introduce salvage therapy (n=5), and ICU hospitalization (n=2)). Results In HERACLES, the GI-ORR was 38% including 5 CR, 2 VGPR and 2 PR. In EAP, positive GI-response was achieved in 31/52 patients (60% with 16 CR, 11 VGPR and 4 PR). Considering the GI-BOR, 13/24 (54%) and 35/52 (67%) achieved at least a PR in HERACLES and EAP respectively. In HERACLES, OS was 29% at month (M) 6 and 25% at M12. OS was significantly higher in responding (R) patients (achieving at least PR at D28) compared to non-responding (NR) (44% vs 20% at M6 and 44% vs 13% at M12, logrank p=0.047). In EAP, OS was 48% at M6 and 37% at M12, and significantly higher in R patients compared to NR (71% vs 17% at M6 and 62% vs 6% at M12, logrank p<0.0001). In HERACLES, treatment with MaaT013 was characterized by excellent tolerance: 252 Treatment-Emergent Adverse Events (TEAE) were reported for the 24 patients, the majority being infections (79%) and GI disorders (62%), as expected in GvHD patients. Of these 252 TEAE, only 2% (5 serious events in 2 patients) could not reasonably be excluded from being related to MaaT013 by the investigators. Shotgun sequencing in these 5 TEAE revealed that the causative infectious agents could not be detected in the administered MaaT013. In EAP, the safety profile of MaaT013 was considered satisfactory for all patients. 16S microbiome analyses were performed in the HERACLES population and showed that MaaT013 produced an early increase in α-diversity at genus level with a significant increase in Richness index at all evaluated timepoints (p <0.003). At D28, R patients had higher values of α-diversity indices (Shannon p=0.005 and Richness p=0.038) compared to NR patients, and higher proportions of MaaT013-derived species in the total composition of R microbiota (p=0.043). Conclusion We herein report the treatment of 76 SR-GI-aGvHD patients using a full ecosystem, pooled-donor, high-richness biotherapeutic. The D28 GI-ORR was 38% and 60% in HERACLES and EAP respectively and this clinical benefit positively and significantly impacted OS (44% and 62% M12 in HERACLES and EAP R patients respectively). MaaT013 was shown to be safe and effective in these heavily immunocompromised patients, warranting further exploration of this approach. Figure 1 Figure 1. Disclosures Malard: JAZZ pharmaceuticals: Honoraria; Sanofi: Honoraria; Astellas: Honoraria; Biocodex: Honoraria; Therakos/Mallinckrodt: Honoraria; Janssen: Honoraria. Loschi: CELGENE/BMS: Honoraria; AbbVie: Ended employment in the past 24 months, Honoraria; Gilead: Ended employment in the past 24 months, Honoraria; Novartis: Ended employment in the past 24 months, Honoraria; Servier: Ended employment in the past 24 months, Honoraria; MSD: Honoraria. Cluzeau: Agios: Honoraria; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel, accommodations, expenses, Speakers Bureau; Roche: Consultancy, Honoraria; BMS/Celgene: Consultancy, Honoraria, Speakers Bureau; Jazz Pharma: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria, Speakers Bureau; Amgen: Speakers Bureau; Pfizer: Other: travel, accommodations, expenses; Astellas: Speakers Bureau; Takeda: Other: travel, accommodations, expenses. Huynh: Jazz Pharmaceuticals: Honoraria. Holler: MaaT Pharma: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Vehreschild: SocraTec R&D GmbH: Consultancy, Speakers Bureau; Pfizer: Consultancy, Speakers Bureau; Ferring: Consultancy, Speakers Bureau; Farmak International Holding GmbH: Consultancy, Honoraria, Speakers Bureau; Bio-Mérieux: Consultancy, Speakers Bureau; Basilea: Consultancy, Speakers Bureau; Arderypharm: Consultancy, Speakers Bureau; Alb Fils Kliniken GmbH: Consultancy, Speakers Bureau; Takeda Pharmaceutical: Research Funding; Seres Therapeutics: Research Funding; Roche: Consultancy, Research Funding, Speakers Bureau; Organobalance: Consultancy, Research Funding, Speakers Bureau; Merck/MSD: Consultancy, Research Funding, Speakers Bureau; MaaT Pharma: Consultancy, Research Funding; Immunic AG: Consultancy, Research Funding, Speakers Bureau; Glycom: Research Funding; Gilead Sciences: Consultancy, Research Funding, Speakers Bureau; Evonik: Research Funding; Da Volterra: Consultancy, Research Funding, Speakers Bureau; Biontech: Research Funding; Astellas Pharma: Consultancy, Research Funding, Speakers Bureau; 3M: Research Funding. Gasc: MaaT Pharma: Current Employment. Plantamura: MaaT Pharma: Current Employment. Mohty: Sanofi: Honoraria, Research Funding; Pfizer: Honoraria; Novartis: Honoraria; Takeda: Honoraria; Jazz: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Gilead: Honoraria; Celgene: Honoraria, Research Funding; Bristol Myers Squibb: Honoraria; Astellas: Honoraria; Amgen: Honoraria; Adaptive Biotechnologies: Honoraria.
Background The best preparative regimen for the growing number of older acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients undergoing allogeneic hematopoietic cell transplantation (HCT) from matched related (MRD) or unrelated donors (MUD) remains undefined. A large randomized phase III trial (MC-FludT.14/L study: ClinicalTrials.gov Identifier: NCT00822393) recently demonstrated that myeloablative intravenous (IV) treosulfan (10 g/m² IV on days -4 to -2) in combination with fludarabine (TreoFlu) improves outcome in older and/or comorbid patients with AML in complete remission (CR) or MDS compared with the reference reduced intensity busulfan (0.8 mg/kg IV in 6-hour intervals on days -4 and -3) and fludarabine (30 mg/m² IV on days -6 to -2 in each study arm) regimen. The beneficial effect of the TreoFlu regimen resulted from a significantly reduced non-relapse mortality (NRM) and translated to improved event-free survival (EFS) and overall survival (OS) (Beelen DW et al The Lancet Haematology, 2019). These results raised the question, how this new regimen compares to broadly applied myeloablative regimens, namely busulfan (0.8 mg/kg IV in 6-hour intervals over 4 days) plus cyclophosphamide (120 mg/kg IV over 2 days) (BuCy) or melphalan (140 mg/m² IV over 1 day or 2 days) plus fludarabine (MelFlu) in older AML and MDS patients. To address this question, we performed a comparative analysis of MC-FludT.14/L study patients treated with the TreoFlu regimen and similar patients of the European Blood and Marrow Transplantation Society (EBMT) registry, who underwent HCT from MRD or MUD after the BuCy or MelFlu regimen between 2010 and 2016. Patients and Methods Inclusion criteria were essentially the same as for the MC-FludT.14/L-study (patient age 50 to 70 years [yrs], primary or secondary AML in CR or MDS, Karnofsky-index ≥ 60%, MRD or MUD, 1st HCT). The study objectives were to compare OS, relapse incidence (RI), and NRM at 2 yrs after HCT between the TreoFlu regimen and the BuCy or MelFlu regimen. A total of 1493 EBMT registry patients (median age 58 yrs, AML: n=1135 [76%], MDS: n=358 [24%]) were identified for the comparison with the 252 MC-FludT.14/L patients (median age 61 yrs, AML: n=174 [69%], MDS: n=78 [31%]). A 1:1 matching method based on propensity scores (PS) with 14 patient-, donor-, and disease-characteristics was used to reduce confounding due to differences between regimens and was performed separately for AML and MDS patients. With the exception of comparison between the TreoFlu and BuCy regimen in AML patients, a significantly higher proportion of patients in the TreoFlu regimen subsets had a HCT-comorbidity index > 2 compared to patient subsets treated with the BuCy or MelFlu regimen. Results For patients with AML, the 2-yrs OS estimate was significantly higher after the TreoFlu compared with the BuCy regimen (76.4%, 95%-confidence interval [95%-CI]: 66.8% - 85.9% vs 49.2%, 95%-CI: 36.4% - 62.1%, p<0.001) and MelFlu regimen (72.7%, 95%-CI: 63.7% - 80.7% vs 58.7%, 95%-CI: 48.3% - 69.1%, p=0.04). This was clearly related to the significantly lower 2-yrs NRM estimate after the TreoFlu compared with the BuCy regimen (3.9%, 95-CI: 0% - 8.2% vs 23.5%, 95%-CI: 13.1% - 33.9%, p<0.001) and MelFlu regimen (6.4%, 95-CI: 1.8% - 11.0% vs 17.5%, 95%-CI: 9.6% - 25.5%, p<0.02). For patients with MDS, the differences of the 2-yrs OS and NRM estimates between patient subsets were similar, but were only significant for the comparison of the OS estimate between the TreoFlu and BuCy regimen (72.0%, 95%-CI: 54.4% - 89.6% vs 30.5, 95%-CI: 6.1% - 54.9%, p<0.01). The adjusted hazard ratios of 2-yrs overall mortality and NRM between regimens including all eligible patients by multivariate sensitivity analysis based on Cox proportional hazards models are given in the table below. Notably, no differences between the respective 2-yrs RI were detectable when comparing these patient subsets. Conclusion In older AML and MDS patients, the new TreoFlu regimen compares favorable to the broadly applied myeloablative BuCy and MelFlu regimens. The substantially lower 2-yrs NRM estimate supports its superior tolerability in this patient population. This large retrospective comparative analysis provides a basis for properly designed randomized trials of the new toxicity reduced myeloablative TreoFlu regimen in comparison with other myeloablative regimens in this target population. Table Disclosures Beelen: Medac GmbH Wedel Germany: Consultancy, Honoraria. Stoelzel:Neovii: Other: Travel funding; Shire: Consultancy, Other: Travel funding; JAZZ Pharmaceuticals: Consultancy. Dreger:MSD: Membership on an entity's Board of Directors or advisory committees, Other: Sponsoring of Symposia; Neovii, Riemser: Research Funding; AbbVie, Gilead, Novartis, Riemser, Roche: Speakers Bureau; AbbVie, AstraZeneca, Gilead, Janssen, Novartis, Riemser, Roche: Consultancy.
Introduction Although anti-HLA Antibodies (Abs) are considered an important factor of graft failure in solid organ transplants, their role in allogeneic hematopoietic stem cell transplantation (allo-HSCT) is still undiscovered. Large polymorphism and immunogenicity of HLA-antigens and heterogeneity of anti-HLA Abs warrant the need of such investigation. The purpose of this study was to define the presence of anti-HLA Abs before allo-HSCT from HLA-mismatched unrelated donors and their impact on engraftment and post-transplant full donor’s chimerism. Material and Methods 70 HLA-mismatched donor/recipient pairs entered the study. Indication for allo-HSCT was: ALL, AML, CML, SAA, PNH, MDS and CLL. Preparative regimen was myeloablative in 68pts (97%) and reduced in 2pts (2.3%). Standard GVHD prophylaxis consisted of cyclosporine, methotrexate and pre-transplant anti-thymocyte globulin (69pts) or Alemtuzumab (1pt). HLA A,B,C,DR,DQ alleles were PCR-typed. Single HLA-antigen was mismatched in 46pts, single HLA-allele in 16pts, double antigens or alleles in 2 pts and another 2 pts had combined antigenic/allelic HLA mismatch. Anti-HLA A,B,C,DR,DQ,DP Abs were identified in sera collected prior to the conditioning treatment with use of automated DynaChip assay utilizing microchips bearing purified class I and class II HLA antigens. Post-transplant chimerism was analyzed using STR-PCR method at 30, 100-days and 1-year after allo-HSCT. Results Anti-HLA Abs pre-formed before allo-HSCT were detected in 32pts: against class I, II or both in 13(18.6%), 7(10%) and 12(17.1%) pts. Anti-HLA Abs were detected after allo-HSCT in 49pts: against class I, II or both in 22(32.4%), 7(10.3%) and 20(29.4%) pts, respectively. Anti-HLA Abs directed against the mismatched HLA antigens were observed in 4 pts before allo-HSCT. Although no Abs specific to mismatched HLA alleles were detected, Abs belonging to the same Cross-Reactive Groups (CREGs) were present in 5pts. No graft failure has been observed (graft failure was defined as absence of neutrophil recovery by day 30 after allo-HSCT or loss of donor’s chimerism). The detection of anti-HLA Abs before allo-HSCT was associated with decrease of post-transplant donor’s chimerism (18/31 vs 11/35, p=0.03). Anti-HLA Abs had no significant impact on engraftment of platelets and neutrophils. The median time to neutrophils engraftment was 16.9 days (range 7-31 days) in pts with and 18.9 days (range 13-30 days) in pts without anti-HLA Abs (p=0.188). The median time to platelets engraftment was 16.9 days (range 9-31 days) in patients with and 18.3 days (range 10-32 days) in pts without anti-HLA Abs (p=0.274). Conclusions Our preliminary results indicate, that anti-HLA Abs are present before transplantation in mismatched allo-HSCT recipients. They influence the post-transplant full donor’s chimerism, but they did not influence engraftment and graft failure. Disclosures: No relevant conflicts of interest to declare.
AIMS: Oral mucositis (OM) is a frequent complication of myeloablative therapy and hematopoietic stem cell transplantation (HSCT). Palifermin was found to reduce the incidence, duration and severity of OM induced by high-dose chemotherapy with HSCT (Bone Marrow Transplant.2007;40:983–8). However, additional data on the long-term safety of palifermin and its potential influence on graft versus host disease (GvHD) were missing. In this multi-center, non-randomized, matched-control study we assessed overall survival (OS), incidence and severity of acute/chronicGvHD (a/cGvHD) and incidence of secondary malignancies in patients with hematological diseases treated with HSCT who received palifermin as a prophylaxis for OM. METHODS AND RESULTS: One hundred and twenty patients with hematological diseases transplanted between December 2001 and December 2007 were enrolled to this study. Sixty patients (50%) received palifermin (60μg/kg/day) for three consecutive days before and after conditioning therapy (palifermin group). Median age of patients was 37.5 years (range, 19 to 63) in the palifermin group and 35.5 years (range, 18 to 64) in the control group. There were no statistical differences between studied groups in terms of other clinical characteristics, including gender, diagnosis, type of transplant, conditioning regimens or GvHD prophylaxis. Kaplan-Meier curves for OS were calculated and compared using the log-rank test. Fisher’s exact and the χ2 trend tests were applied for the analysis of the GvHD data. Twenty one (35%) autologous and thirty nine (65%) allogeneic HSCT (HLA-matched related and unrelated) were performed in each group. Following allogeneic HSCT, the incidence of aGvHD grade 1–4 was 28.2% and 38.4% (p=0.34) and cGvHD was 41% and 53.8% (p=0.70) in the palifermin and control groups, respectively. The incidence of aGvHD severity grade 0,I,II,III,IV was 69.2%, 5.1%, 17.9%, 2.5%, 2.5% in the palifermin and 61.5%, 12.8%, 12.8%, 10.2%, 5.2% in the control group, respectively (p>0.4 for each). The incidence of limited and extensive cGvHD was 17.9% and 23% in the palifermin group versus 25.6% and 28.2% in the control group (p=0.32 and p=0.50, respectively). The estimated 2-years OS (72.8% and 79.8%, respectively) also didn’t differ significantly between studied groups (p=0.13). We didn’t observe any secondary malignancies in patients enrolled into the study. CONCLUSIONS: Administration of palifermin doesn’t seem to influence the incidence and severity of a/cGvHD, secondary malignancies occurrence and OS in patients with hematological diseases undergoing HSCT.
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