Grafalon (rabbit anti-T-lymphocyte globulin) / Mundipharma, NeoPharm, Zydus Lifesciences - LARVOL DELTA

FORUM: Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia (clinicaltrials.gov) - P2/3 | N=1800 | Recruiting | Sponsor: St. Anna Kinderkrebsforschung | Trial primary completion date: Jun 2025 ➔ Jun 2030

Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation

Eplet mismatch does not predict outcomes in living related kidney transplantation as induction therapy overrides molecular risk (TTS 2026) - "Induction therapy included: • Thymoglobulin® • Grafalon® • Basiliximab • Steroid-onlyInduction regiemen, immunogenic eplet burden and graft function Patients were classified as stable or graft dysfunction... In this living-related transplant cohort, eplet mismatch did not perform as expected from existing models. Neither DR nor Class I mismatch alone reliably predicted graft outcomes. Instead, the data suggest a more layered biology."

Biomarker • Antibody-mediated Rejection • Transplantation

Successful Renal Transplantation in a Patient With Methylmalonic Acidemia and ESRD: A Case Report (TTS 2026) - "Induction therapy consisted of a single vial of Grafalon, followed by a standard triple-drug immunosuppressive regimen... This case demonstrates that renal transplantation, even in an ABO-incompatible setting, is feasible and effective in patients with MMA. With appropriate immunosuppression and metabolic dietary management, excellent short-term outcomes and improved metabolic stability can be achieved."

Case report • Clinical • Chronic Kidney Disease • CNS Disorders • Dystonia • Genetic Disorders • Hematological Disorders • Metabolic Disorders • Movement Disorders • Nephrology • Ophthalmology • Renal Disease • Transplantation

Catch up growth in children following renal transplantation: Observations from an emerging pediatric renal transplant center in south Asia (TTS 2026) - "The induction agent was Grafalon in 66% (12/18), while the remaining 33% (n = 6) received Basiliximab. Growth restoration in most patients was suboptimal. All growth parameters, such as weight, height, and body mass index, need to be monitored post-transplant. Interventions to promote growth should begin soon after diagnosis of CKD to improve the linear growth outcomes in children post-transplant."

Clinical • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Genetic Disorders • Glomerulonephritis • Lupus Nephritis • Nephrology • Pediatrics • Transplantation

ATLG induction at lower dose in kidney transplant-effective and cheaper (TTS 2026) - "Higher Grafalon induction dosing (3 mg/kg) was associated with significantly increased infection rates and mortality without additional benefit in rejection prevention. Lower-dose Grafalon (1 mg/kg) may provide a safer balance between immunosuppression and infection risk in high-risk kidney transplant recipients. RESULTS"

Infectious Disease • Nephrology • Respiratory Diseases • Septic Shock • Transplant Rejection • Transplantation

ALC guided precision ATLG induction dosing strategy: a tool in optimising outcomes in Kidney Transplant recipients (TTS 2026) - "Background: Fixed high-dose antithymocyte globulin (ATLG, Grafalon®️) is an effective induction strategy in intermediate-risk kidney-transplant recipients (KTR) but increases cost and may heighten infection risk... ALC-guided ATLG induction achieved a one-sixth reduction in drug exposure with low early rejection and acceptable infection rates. This pragmatic, bedside-driven strategy offers a cost-saving, patient-individualised alternative to fixed high-dose induction. Larger randomised trials with longer follow-up are warranted to establish non-inferiority and assess long-term graft outcomes."

Clinical • Infectious Disease • Nephrology • Transplant Rejection • Transplantation

Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients (TRAINING) (clinicaltrials.gov) - P4 | N=80 | Active, not recruiting | Sponsor: Fundación Canaria Instituto de Investigación Sanitaria de Canarias | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2024 ➔ Jun 2027 | Trial primary completion date: Jun 2024 ➔ Jun 2027

Enrollment closed • Trial completion date • Trial primary completion date • Transplant Rejection • Transplantation

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

GRAPPA: GvHD Prophylaxis in Unrelated Donor HCT: Randomized Trial Comparing PTCY Versus ATG (clinicaltrials.gov) - P3 | N=640 | Active, not recruiting | Sponsor: DKMS gemeinntzige GmbH | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Jun 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Myelodysplastic Syndrome • Transplantation • HLA-DRB1

Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov) - P3 | N=66 | Active, not recruiting | Sponsor: Children's Oncology Group | N=435 ➔ 66 | Trial completion date: Jun 2026 ➔ Jul 2027

Enrollment change • Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • ABL1 • BCR • CEBPA • FLT3 • HLA-B • HLA-C • HLA-DQB1 • HLA-DRB1 • KMT2A • NPM1

REAL-WORLD USE OF POST-TRANSPLANT CYCLOPHOSPHAMIDE FOR GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS AFTER ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION: A SURVEY FROM THE CTIWP OF EBMT (EHA 2026) - "One-third of centers (33%) combined PTCy with ATG, using Thymoglobulin and Grafalon at similar frequencies. Cyclosporine plus mycophenolate mofetil (58%) and tacrolimus plus mycophenolate mofetil (43%) were the predominant adjunct prophylaxis strategies...Summary/Conclusion This large international EBMT survey demonstrates widespread adoption of PTCy for GVHD prophylaxis across different donor types, but reveals substantial heterogeneity in dosing strategies, dose modification, supportive care, and combination approaches. These findings highlight the need for harmonized guidance and prospective studies to optimize and standardize PTCy-based GVHD prophylaxis across donor settings."

Clinical • Post-transplantation • Real-world • Real-world evidence • Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Obesity

MATCHED SIBLING DONOR TRANSPLANTATION FOR THALASSEMIA MAJOR: A LONG-TERM STUDY EVALUATING ATG FORMULATIONS AND THIOTEPA IN THE CONDITIONING REGIMEN (EHA 2026) - "Aims This study aimed to evaluate the long-term outcomes of MSD-HSCT using a busulfan-cyclophosphamide-fludarabine (BuCyFlu) based conditioning regimen in children with TM, and to analyze the effects of different anti-thymocyte globulin (ATG) formulations (Fresenius [ATG-F] vs. Thymoglobulin [ATG-T]) and the addition of thiotepa (TT)...GVHD prophylaxis consisted of ATG (ATG-F or ATG-T), cyclosporine A, and short-course methotrexate...Within this highly effective protocol, the choice of ATG formulation did not significantly affect outcomes. The addition of thiotepa modulated GVHD risk, reducing severe acute forms but increasing chronic GVHD, highlighting the need for nuanced conditioning strategy design based on specific risk profiles."

Acute Graft versus Host Disease • Beta-Thalassemia • Bone Marrow Transplantation • Cardiovascular • Chronic Graft versus Host Disease • Congestive Heart Failure • Genetic Disorders • Graft versus Host Disease • Heart Failure • Hematological Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Severe IgE-Mediated Anaphylactic Shock to Rabbit-Derived Anti-Thymocyte Globulin (Grafalon®) During Kidney Transplantation in a Patient with Rabbit Allergy (EAACI 2026) - "Although generally well tolerated, severe hypersensitivity reactions remain rare but potentially life-threatening complications. With the increasing use of biologics in transplantation and immunotherapy, awareness of rare but severe IgE-mediated reactions remains crucial, and preexisting sensitization should be considered in individualized risk-adapted induction strategies."

Clinical • Preclinical • Allergy • Immunology

OPTISAGE: Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 10/10 HLA Matched Unrelated Donor (clinicaltrials.gov) - P3 | N=324 | Recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris | Trial primary completion date: Feb 2027 ➔ Nov 2028 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial primary completion date • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • Transplantation

Effect of preexisting human leukocyte antigen donor-specific antibodies especially human leukocyte antigen-DQ on kidney transplant outcome. (PubMed, Front Nephrol) - "All recipients were followed for a minimum of 4 years post-transplant, and induction immunosuppression was administered using either anti-thymocyte globulin (ATG) or ATLG (Grafalon®)...DQ DSAs with lower MFI require vigilant monitoring due to the risk of post-transplant rebound. ATLG-based induction was associated with low rejection incidence and favorable short-term outcomes."

Journal • Antibody-mediated Rejection • Transplantation

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

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 • Genetic Disorders • Graft versus Host Disease • Hematological Disorders • Hepatology • Immunology • Mucositis • Neutropenia • Pediatrics • Transplantation • CD34

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

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

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

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

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

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

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

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