Grafalon (rabbit anti-T-lymphocyte globulin)
/ Mundipharma, NeoPharm, Zydus Lifesciences
- LARVOL DELTA
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February 07, 2026
PROPHYLACTIC TOCILIZUMAB FOR THE PREVENTION OF ACUTE GRAFT-VERSUS-HOST DISEASE IN MATERNAL HAPLOIDENTICAL HEMATOPOIETIC STEM CELL TRANSPLANTATION: A PROSPECTIVE SINGLE-ARM STUDY
(EBMT 2026)
- P2 | "Anti-thymocyte globulin Fresenius (ATG-F 10mg/kg) or anti-thymocyte globulin-Genzyme (ATG-G 6mg/kg) was applied. One intravenous dose of TCZ (8 mg/kg) was given the day before stem cell transfusion along with standard GVHD prophylaxis (cyclosporin plus short-term methotrexate and mycophenolate mofetil)... In conclusion, prophylactic tocilizumab is safe, biologically rational, and clinically promising for reducing aGVHD after maternal haploidentical HSCT. Larger multicenter randomized trials are warranted to validate these findings."
Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Infectious Disease • Septic Shock • Transplantation • CD4 • CD8 • IL6
February 07, 2026
ALLOGENEIC HSCT IN A 7-YEAR-OLD GIRL WITH ADULT-TYPE PRIMARY MYELOFIBROSIS: A RARE CASE REPORT
(EBMT 2026)
- "Bridging therapy with the JAK inhibitor ruxolitinib was given for 30 days to facilitate engraftment with tapering prior to conditioning.In May 2025, the patient underwent allo-HSCT from a matched sibling donor using EWOG-MDS–based conditioning with busulfan (AUC 75 mg·h/L), cyclophosphamide (120 mg/kg), melphalan (140 mg/m² ×1), and ATG Grafalon (30 mg/kg). GvHD prophylaxis consisted of tacrolimus and methotrexate... Adult-type primary myelofibrosis in childhood is extraordinarily rare, with only very few pediatric cases described, leaving no evidence-based guidelines for transplant management. This case adds clinical experience for HSCT decision-making in such patients. Despite significant post-transplant complications, the patient achieved full donor chimerism and remains clinically well six months post-transplant."
Case report • Clinical • Bone Marrow Transplantation • Fibrosis • Graft versus Host Disease • Hematological Disorders • Hepatology • Immunology • Infectious Disease • Myelofibrosis • Myeloproliferative Neoplasm • Pneumonia • Pulmonary Disease • Respiratory Diseases • Thrombocytosis • Transplant Rejection • CALR • CD4 • JAK2
February 07, 2026
IMPROVED ENGRAFTMENT FOLLOWING A TREOSULFAN-FLUDARABINE CONDITIONING REGIMEN COMPARED TO THIOTEPA-FLUDARABINE IN PATIENTS WITH REFRACTORY CYTOPENIA OF CHILDHOOD
(EBMT 2026)
- "Different types of serotherapy were used in unrelated HSCT (ATG Grafalon 88%, Thymoglobulin 7%, alemtuzumab 5%), and 36% of MSD recipients received ATG (ATG Grafalon 82%, Thymoglobulin 18%)... Although both regimens offered an excellent OS for patients with RCC, the Treo-Flu regimen resulted in superior engraftment and lower rates of cGVHD. Serotherapy provided no benefit in MSD-HSCT and a higher-dose ATG Grafalon adversely affected outcomes in unrelated HSCT with Thio-Flu likely through impaired immune reconstitution. Comprehensive evaluation of long-term consequences, including fertility outcomes, is required."
Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Disorders • Immunology • Renal Cell Carcinoma
February 07, 2026
RESULTS OF ALLOGENEIC HSCT IN CR1 FOR PEDIATRIC PATIENTS WITH DE NOVO, HIGH-RISK, ACUTE MYELOID LEUKEMIA (AML): A REPORT FROM AIEOP
(EBMT 2026)
- "The recommended conditioning regimen was busulfan+cyclophosphamide+melphalan in case of transplant from an HLA-matched donor, while for mMUD or PMFD conditioning was chosen by the treating physician. GvHD prophylaxis consisted of short-course methotrexate and cyclosporine-A; serotherapy (Grafalon 5 mg/kg/day for 3 days) was added in patients transplanted from an unrelated donor... These data confirm improvement in transplant technique in recent years, as supported by the low incidence of NRM, and indicate that allo-HSCT is an efficacious option for consolidation of pediatric patients with HR AML."
Clinical • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Pediatrics • Septic Shock • CBFA2T3 • CD34 • FLT3 • GLIS2 • KMT2A • NUP98
February 07, 2026
IMPACT OF ANTI-T-LYMPHOCYTE GLOBULIN DOSING ON GRAFT VERSUS HOST DISEASE IN MATCHED SIBLING PERIPHERAL BLOOD STEM CELL TRANSPLANTATION
(EBMT 2026)
- "Patients received either ATLG 15 mg/kg (ATLG-15, n=71) or 30 mg/kg (ATLG-30, n=94; Grafalon®)... In MSD-PBSCT, ATLG 30 mg/kg was associated with a clinically meaningful reduction in moderate-to-severe chronic GVHD and improved GRFS, without adversely affecting relapse or non-relapse mortality. These findings support a quality-of-survival benefit of higher ATLG dosing in this setting and warrant prospective validation in multicentre studies."
Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • Transplantation
February 07, 2026
THE CLINICAL COURSE OF HAPLOHSCT + DINUTUXIMAB BETA IMMUNOTHERAPY IN POLISH CHILDREN WITH RELAPSING NEUROBLASTOMA
(EBMT 2026)
- "The procedure included FluMelTT ( Fludarabin 4 x 40 mg/m2 BSA, Thiotepa 10 mg/kg body weight, melphalan 2 x 70 mg/m2 BSA ) conditioning + ATG Grafalon in dose 30mg/kg with immunosuppresion – mycophenolate of mofetil depending of the T cell level in transplant (600-1200 mg/ kg body weight ) and G-CSF support from +4 day after HSCT...3 patients received 131I MIBG therapy 2-3 weeks before transplantation... HaploHSCT with dinutuximab beta therapy seems to be encouraging method of treatment for children with relapsing neuroblastoma, connecting chemotherapy and immunotherapy. This method seems to be well tolerated with no serious toxicities. Although due to posiible toxicities of the method, the patients should be carefully selected to this method of theatment."
Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Dental Disorders • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Neuroblastoma • Septic Shock • Solid Tumor • Stomatitis
February 07, 2026
SAFETY PROFILES OF TWO ANTI-THYMOCYTE GLOBULIN FORMULATIONS IN PEDIATRIC HEMATOPOIETIC CELL TRANSPLANTATION: IMPLICATIONS FOR NURSING CARE
(EBMT 2026)
- "Currently, two main ATG formulations are used in clinical practice: Thymoglobulin® (rabbit-derived anti-human thymocyte immunoglobulin) and Grafalon® (anti-human T lymphocyte immunoglobulin). Grafalon demonstrated a more favorable safety profile during the first 72 hours of ATG infusion compared to Thymoglobuline. Its higher incidence of capillary leak and ICU transfer underscores the need for adequate nursing staffing and training to ensure patient safety. These findings should be interpreted with caution as they are based on preliminary data from a single center; results will be complemented by data from additional centers and multivariate analyses to control for confounding factors."
Clinical • Cardiovascular • Graft versus Host Disease • Hypertension • Hypotension • Immunology • Pediatrics • Transplantation
February 07, 2026
REAL-WORLD SINGLE-CENTER EXPERIENCE OF ANTI-THYMOCYTE/ ANTI-T-LYMPHOCYTE GLOBULINS IN POST-TRANSPLANT CYCLOPHOSPHAMIDE CONDITIONINGS OF HAPLOIDENTICAL AND UNRELATED ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION: SAFETY, EFFICACY, AND ENDOTHELIAL INJURY PROFILE
(EBMT 2026)
- "Background: Different types of globulins, such as thymoglobulin (ATG) and Grafalon (ATLG), in combination with post-transplant cyclophosphamide (PTCY), have been incorporated into graft-versus-host disease (GvHD) prophylaxis regimens for haploidentical and unrelated allogeneic hematopoietic cell transplantation (allo-HCT) over the last few years... Endothelial injury markers and clinical outcomes were similar between ATLG/ ATG and PCTY, with an excellent survival and safety profile."
Clinical • Post-transplantation • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Transplantation
February 07, 2026
T CELL-DEPLETED HAPLOIDENTICAL AND MATCHED UNRELATED DONOR HEMATOPOIETIC STEM CELL TRANSPLANTATION REPRESENT SAFE AND EFFICIENT THERAPEUTIC APPROACHES FOR PEDIATRIC PATIENTS WITH BONE MARROW FAILURE SYNDROMES
(EBMT 2026)
- "Five patients received a conditioning regimen based on fludarabine and cyclophosphamide (FC) and three fludarabine, thiotepa, treosulfan (FTT), along with ATG-Grafalon® or thymoglobulin. One SD patient received a MUD-PBSC, conditioned with fludarabine, thiotepa and melphalan (FTM). Immunosuppression (IST) consisted of tacrolimus (or cyclosporine) and mycophenolate mofetil (MMF) in all nine patients...One case of veno-occlusive disease (VOD) in a T-haplo-HSCT patient with FA resolved completely after treatment with defibrotide... This single-center, retrospective series supports feasibility and safety of T-haplo-HSCT in rare BMF syndromes and indicates favorable outcomes in T-haplo-HSCT with fast engraftment, low GVHD, and a reduced risk of severe toxicity compared to MUD-HSCT in children."
Clinical • Acute Graft versus Host Disease • Aplastic Anemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Dermatitis • Dermatology • Genetic Disorders • Graft versus Host Disease • Hematological Disorders • Hepatology • Immunology • Mucositis • Neutropenia • Pediatrics • Transplantation • CD34
February 07, 2026
TREOSULFAN-FLUDARABINE AS A REDUCED INTENSITY CONDITIONING ALTERNATIVE TO BUSULFAN-FLUDARABINE FOR ADULT ALLOGENEIC STEM CELL TRANSPLANTATION: SINGLE-CENTER, EARLY REAL-LIFE CLINICAL AND ECONOMICAL COMPARATIVE OUTCOMES
(EBMT 2026)
- " We retrospectively reviewed all allo-HCTs performed between 2021 and 2025 using FT10 or FB2 conditioning, both combined with anti-lymphocyte globulin ((ATG) Thymoglobulin 5 mg/kg or Grafalon 30 mg/kg), for adults with AML or MDS. Transplant practices were identical across the study period: peripheral blood stem cell grafts, ciclosporine + methotrexate for GVHD prophylaxis, letermovir prophylaxis, and unchanged center-level procedures and teams... Despite being used in a substantially higher-risk population, FT10 achieved early post-transplant outcomes comparable to FB2, with a lower burden of early unplanned healthcare costs. These findings support the feasibility and cost effectiveness of FT10 as a reduced-toxicity RIC option for AML/MDS."
Clinical • Acute Graft versus Host Disease • Graft versus Host Disease • Hepatology • Immunology • Transplantation
February 07, 2026
TREOSULFAN BASED MYELOABLATIVE CONDITIONING IN ADOLESCENT AND ADULT PATIENTS WITH HEMOGLOBINOPATHY
(EBMT 2026)
- "All patients received a conditioning regimen consisting of treosulfan (3 x 14 g/m²), thiotepa (2 x 5 mg/kg BW), fludarabine (4 x 40 mg/m²), and ATG-Grafalon®, with the only difference being in the timing of ATG (upfront 3 x 15 mg/kg BW in T-haplo-HSCT, 3 x 10 mg/kg BW in MSD-HSCT on days -3 to -1). Immunosuppression involved a combination of calcineurin inhibitors and mycophenolate mofetil...Three patients developed mild hepatic SOS, all responding well to defibrotide and fully recovering... Treosulfan-based conditioning proved to be safe, myeloablative, and highly immunosuppressive. It emerges as an excellent alternative to busulfan in this high-risk population, with no cases of conditioning-related graft failure, no significant mixed chimerism, and neither severe GVHD nor SOS."
Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Epstein-Barr Virus Infections • Gastroenterology • Genetic Disorders • Graft versus Host Disease • Hematological Disorders • Hepatology • Immunology • Infectious Disease • Sickle Cell Disease • CD14
February 07, 2026
ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR MYELOFIBROSIS: PATTERNS AND OUTCOME AFTER RELAPSE AND LONG-TERM FOLLOW UP
(EBMT 2026)
- "The conditioning regimen was fludarabine and reduced dose intravenous busulfan (FluBu, total 6.4-8 mg/kg, n=25); fludarabine, thiotepa, busulfan (TBF, n=61) or other regimens (n=16). GVHD prophylaxis included cyclosporine and methotrexate or mycophenolate and ATG (grafalon).With a median follow-up of 5.6 years (range, 0.1-22 years), 56 patients are alive and 46 have died, 30 of non-relapse causes and 16 of relapse... Allogeneic HSCT can allow long-term survival and possible cure in myelofibrosis. However, long-term survivors are at continuous risk for late relapse and late NRM. For those who are not cured, HSCT may reset the pattern of progression of the myeloproliferative process."
Acute Myelogenous Leukemia • Bone Marrow Transplantation • Cardiovascular • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Myelofibrosis • Polycythemia Vera • Transplantation
February 07, 2026
ABSOLUTE LYMPHOCYTE COUNT AT ANTI-T-LYMPHOCYTE GLOBULIN DOES NOT PREDICT GVHD INCIDENCE AND GVHD/RELAPSE FREE SURVIVAL AFTER MATCHED UNRELATED DONOR TRANSPLANTATION: A TWO-CENTER VALIDATION STUDY
(EBMT 2026)
- "In matched unrelated donor (MUD) transplantation, in vivo T-cell depletion with anti-thymocyte globulin (ATG; Thymoglobulin®) or anti-T-lymphocyte globulin (ATLG; Grafalon®) is widely used for GVHD prophylaxis, although optimal dosing strategies remain undefined... ALC on the first day of ATLG administration does not represent a consistent prognostic biomarker across centers when a fixed cumulative dose of 30 mg/kg is used. In the Bologna cohort, the association between higher ALC and lower relapse incidence is biologically plausible and compatible with a pharmacodynamic model in which higher recipient lymphocyte counts bind more ATLG, resulting in reduced effective immunosuppression and preserved graft-versus-leukemia activity. In contrast, the opposite association observed in the UKE cohort appears more likely influenced by center-specific factors and residual confounding."
Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Transplantation
February 07, 2026
IMLIFIDASE EFFICIENTLY ABROGATES THE EFFECT OF ATLG AND THYMOGLOBULIN ON T- AND NK-CELL VIABILITY AND FUNCTION
(EBMT 2026)
- "Background: ATLG (Grafalon) and Thymoglobulin are long-established agents in allogeneic hematopoietic stem cell transplantation (allo-HSCT), effectively preventing both graft rejection and graft-versus-host disease (GvHD)... Imlifidase markedly attenuates the impact of ATLG/Thymoglobulin on NK-cell function and abrogates ATLG-/Thymoglobulin-mediated cytotoxicity on T-/NK-cells. This effect of imlifidase is to be evaluated in a clinical study in the context of T-/B-cell-depleted allo-HSCT in order to determine whether pre-transplant application of imlifidase (e.g. on day-2) results in effective inactivation of ATLG/Thymoglobulin in vivo and thereby accelerates post-transplant immune reconstitution."
Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Transplant Rejection • IL2 • NCAM1
February 07, 2026
ADMINISTRATION OF GRAFALON® (ATLG) WITH A GRADUALLY INCREASING INFUSION RATE: IMPACT ON TOLERABILITY IN PEDIATRIC PATIENTS UNDERGOING HEMATOPOIETIC STEM CELL TRANSPLANTATION
(EBMT 2026)
- "The adoption of a progressively increasing infusion rate for Grafalon® administration proved effective in reducing the severity of infusion reactions, ensuring better tolerability and treatment continuity. This experience highlights that a standardized and shared nursing protocol for drug administration and monitoring represents a safe and reproducible strategy, with potential benefits for the quality of care in pediatric HSCT patients."
Clinical • Bone Marrow Transplantation • Cardiovascular • Graft versus Host Disease • Immunology • Pediatrics • Transplant Rejection • Transplantation
February 07, 2026
COMPARATIVE OUTCOMES AFTER SEROTHERAPY WITH ATLG-GRAFALON OR ATG-THYMOGLOBULIN IN PEDIATRIC ALL PATIENTS GIVEN MUD ALLOGENEIC HSCT: FINDINGS FROM THE INTERNATIONAL PROSPECTIVE FORUM STUDY
(EBMT 2026)
- "The two main ATGs – ATLG-Grafalon® (Neovii) and ATG-Thymoglobulin® (Sanofi) – are polyclonal antibodies generated by immunizing rabbits with Jurkat T-cells or human thymocytes, respectively...Patients ≥4 years were conditioned with either total-body irradiation (TBI 12Gy and etoposide, cohort1) or chemo-conditioning with either busulfan or treosulfan combined with thiotepa and fludarabine (cohort2)... In patients ≥4y who received TBI-based conditioning – current standard of care – outcomes were excellent following either serotherapy. Differences emerged only for PBSC grafts, where Thymoglobulin was associated with higher NRM and lower OS and EFS. Among patients >4y conditioned with chemotherapy, outcomes did not differ by serotherapy."
Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Infectious Disease • Pediatrics
February 07, 2026
AUTOLOGOUS UMBILICAL CORD BLOOD TRANSPLANTATION WITHOUT CHEMOTHERAPY-BASED CONDITIONING IN A CHILD WITH SEVERE APLASTIC ANEMIA: A CASE REPORT
(EBMT 2026)
- " Immunoablation was initiated with four doses of equine antithymocyte globulin (Atgam, 40 mg/kg), after which a substantial number of residual T lymphocytes was observed (818/µL). To intensify the immunoablation, the patient subsequently received a 3-day course of antithymocyte globulin (Grafalon, 5 mg/kg), followed by a 2-day course of antithymocyte globulin (Thymoglobulin, 3.75 mg/kg), administered with methylprednisolone and cyclosporine A. Subsequently, the child underwent auto-UCBT containing 0.13 × 10⁶ CD34+ cells/kg and continued treatment with cyclosporine A and prednisone... Early neutrophil recovery may indicate better underlying stem cell reserve, due to auto-UCBT infusion, though this interpretation remains speculative. Auto-UCBT after immunosuppression-based protocol appears to be a promising curative option for pediatric SAA patients with stored autologous cord blood and without available matched sibling. A key prerequisite for autoUCBT in SAA is..."
Case report • Clinical • Anemia • Aplastic Anemia • Bone Marrow Transplantation • Hematological Disorders • Transplantation • CD34
February 07, 2026
ATG EXPOSURE AND IMMUNE RECONSTITUTION IN CHILDREN WITH HEMOGLOBINOPATHIES FOLLOWING HSCT: DIFFERENT PATTERNS FOR ATG-GRAFALON AND THYMOGLOBULINE
(EBMT 2026)
- "Rabbit ATG preparations differ markedly in antibody spectrum and pharmacokinetics (PK), resulting in non-interchangeable exposure–response profiles. Eighty-six pediatric patients (90 HSCTs; 4 re-transplantations; median age 11.13 years) underwent transplantation for hemoglobinopathies (2011–2025) using treosulfan/fludarabine/thiotepa conditioning...In the ATLG cohort, 46.3% also received post-transplant cyclophosphamide (ptCy), which was associated with reduced severe cGvHD without evidence of impaired IR... ATG exposure is a key determinant of IR in pediatric hemoglobinopathy HSCT. ATLG and ATG-T display distinct PK/PD profiles, underscoring the need for individualized, product-specific exposure–response assessment. Weight-based dosing results in substantial variability, particularly in older children."
Clinical • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Immunology • Transplant Rejection • CD4 • CD8
February 07, 2026
RELIABLE ENGRAFTMENT AND COMPARABLE OUTCOMES ACROSS DONOR SOURCES WITH BUSULFAN65–FLUDARABINE–THIOTEPA CONDITIONING IN PAEDIATRIC SICKLE CELL DISEASE
(EBMT 2026)
- " We report on 35 symptomatic SCD patients aged 1-17 years (median 6) transplanted between 2014 and 2025 on an institutional protocol (including an established psychosocial support framework) with a uniform conditioning: busulfan tAUC 65ng*h/ml, fludarabine 150mg/m² and thiotepa 10mg/kg (plus cyclophosphamide 29mg/kg in MMFD)...All patients received serotherapy depending on donor source and HLA match: alemtuzumab 0.4mg/kg for MMFD, 0.8mg/kg for (M)MUD and ATG Grafalon® 45mg/kg for MSD/MFD... These results, obtained in a relatively young and otherwise healthy pediatric cohort treated with a Bu65–Flu–TT conditioning regimen, demonstrate reliable engraftment and similarly favorable outcomes across MSD/MFD, (M)MUD, and MMFD donors. These findings may pave the way for broader consideration of very early HSCT from alternative donors in children with SCD."
Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Chronic Kidney Disease • Genetic Disorders • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Nephrology • Novel Coronavirus Disease • Pediatrics • Pulmonary Disease • Respiratory Diseases • Sickle Cell Disease
February 07, 2026
ASS-T CELL DEPLETED HAPLOIDENTICAL HSCT FOR PEDIATRIC AND ADULT PATIENTS WITH SICKLE CELL DISEASE: INTERIM ANALYSIS OF THE T-HAPLO-HSCT FOR SCD TRIAL (NCT04201210)
(EBMT 2026)
- P2 | "All patients underwent a standardized, myeloablative conditioning regimen, which included ATG (Grafalon; 45mg/kg for haplo-HSCT respectively 30mg/kg for MSD HSCT), treosulfan, fludarabine, and thiotepa (FTT), followed by post-transplant immunosuppression with tacrolimus and mycophenolate mofetil for 240 and 180 days, respectively for haplo-HSCT and MSD HSCT. aß-depleted haploidentical HSCT is currently being evaluated in a prospective stratified international trial (NCT04201210). The interim results of the ongoing trial show promising outcomes, comparable to MSD HSCT."
Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Genetic Disorders • Graft versus Host Disease • Hematological Disorders • Immunology • Pediatrics • Sickle Cell Disease
February 07, 2026
PROSPECTIVE MULTICENTRE ANALYSIS OF FLUDARABINE EXPOSURE IN CHILDREN RECEIVING FLUDARABINE-TREOSULFAN-THIOTEPA FOR NON-SCID INBORN ERRORS OF IMMUNITY: PRELIMINARY FINDINGS FROM HAPLO+4KIDS
(EBMT 2026)
- "Clinical Trial Registry: Haplo+4Kids – ISRCTN11859866 - https://www.isrctn.com/ISRCTN11859866 Background: Fludarabine (FLU) has largely replaced cyclophosphamide in paediatric reduced toxicity conditioning regimens as it provides potent lymphodepletion to prevent immune mediated graft rejection while offering a more favourable toxicity profile...Serotherapy was alemtuzumab for matched unrelated donor and ATG-Grafalon for TCRab-depleted mismatched family/unrelated donor... Preliminary data indicate considerable interpatient variability in fludarabine exposure in paediatric HSCT patients. Body surface area-based dosing may lead to overexposure, particularly for infant patients. MBD without measured PK data was inaccurate in estimating individual fludarabine exposure in our study cohort, underscoring the importance of real-time therapeutic drug monitoring to enable personalised dosing to achieve a targeted drug exposure to optimise engraftment whilst minimising the risk of..."
Clinical • Bone Marrow Transplantation • Infectious Disease • Transplant Rejection
February 07, 2026
ANTI-T-LYMPHOCYTE GLOBULIN (ATLG) VS. ANTI-THYMOCYTE GLOBULIN (ATG) IN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION: A PRELIMINARY COMPETING-RISK ANALYSIS
(EBMT 2026)
- "Background: Anti-T-lymphocyte globulin (ATLG, Grafalon®, formerly ATG-Fresenius S) and anti-thymocyte globulin (ATG, Thymoglobulin®, formerly ATG-Genzyme) are widely used as part of GvHD prophylaxis prior to allogeneic hematopoietic stem cell transplantation (AHSCT)... Preliminary 3-year data from this real-world cohort suggest that ATLG is associated with a significant reduction in severe acute GvHD within the first 100 days after AHSCT compared with ATG. The final results from the entire 5-year cohort will provide a more reliable assessment not only of the GvHD incidence, but also of long-term survival."
Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Transplantation
February 07, 2026
IMPACT OF RECIPIENT AGE AND CYCLOSPORIN A TARGET LEVEL ON MIXED CHIMERISM AFTER TREOSULFAN-BASED MATCHED FAMILY DONOR HAEMATOPOIETIC STEM CELL TRANSPLANTATION FOR SICKLE CELL DISEASE
(EBMT 2026)
- "All patients received reduced-toxicity protocols (RTPs), which were predominantly treosulfan-fludarabine-thiotepa-based (69.9%). Four-year OS and GSFS did not differ significantly between conditioning regimens (treosulfan-based: 97.1% and 82.8%; busulfan-based: 95.2% and 89.2%; melphalan-based: 100.0% and 77.8%)...This corresponded to a faster reduction (median day: Thymoglobulin® 73, ATG-Fresenius 124 (p<0.001)) and discontinuation (Thymoglobulin® 115, ATG-Fresenius 162 (p<0.001)) of calcineurin inhibitors in this subgroup... The results of our detailed, multicentre data analysis confirm excellent OS across all donor types, but significantly better GSFS after MFD HSCT for SCD. We identified risk factors (Thymoglobulin®, CSA≥150µg/l, age<6 years, reduced myeloablation) for the development of MC in treosulfan-based conditioning regimens. These data should assist in risk-adapted optimization of RTPs especially in the setting of MFD-HSCT."
Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Genetic Disorders • Graft versus Host Disease • Hematological Disorders • Immunology • Sickle Cell Disease • Transplantation
February 05, 2025
SAFETY AND EFFICACY OF FLUDARABINE PLUS MYELOABLATIVE DOSE OF TREOSULFAN (FT14) CONDITIONING REGIMEN FOR AML – INTERIM ANALYSIS FROM THE FT14 STUDY GROUP
(EBMT 2025)
- "While busulfan-based regimens such as fludarabine-busulfan (FB4) are widely regarded as the gold standard for reduced-toxicity myeloablative conditioning, they are associated with risks such as Veno-Occlusive Disease (VOD), pulmonary toxicity, and high Transplant-Related Mortality (TRM)...Graft sources included peripheral blood stem cells or bone marrow, with Graft-versus-Host Disease (GvHD) prophylaxis using ATG (Thymoglobulin or Grafalon), cyclosporine and short course methotrexate...On viral point of view, 6% experienced CMV reactivation despite letermovir prophylaxis, 11% had detectable EBV viraemia (with no case of post-transplant lymphoproliferative disease), 4% had SARS-CoV-2 and 2% HHV6 reactivation... FT14 is a safe and effective myeloablative conditioning regimen for AML, demonstrating excellent disease control with minimal toxicity. Its reduced transplant-related mortality(TRM) and GvHD rates make it particularly beneficial for patients at high risk of..."
Clinical • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hepatology • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases
January 17, 2026
Rapid in vivo loss of non-T-cell binding capacities of ATLG Grafalon® and ATG Thymoglobulin® explains selective effect on T-cell reconstitution after hematopoietic stem cell transplantation.
(PubMed, Biochim Biophys Acta Gen Subj)
- "This real-life specificity of ATG and ATLG explains their selective impact on T-cell reconstitution. These findings enhance our understanding of the mechanisms of action of ATG and ATLG and may contribute to optimization of these therapies."
Journal • Preclinical • Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Pediatrics • Transplantation
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