Campath (alemtuzumab) / Bayer, Sanofi - LARVOL DELTA

Alemtuzumab Exposure and T Lymphocyte Depletion: A Population Pharmacokinetic-Pharmacodynamic Model of Alemtuzumab Induction Therapy for Kidney Transplantation. (PubMed, Clin Pharmacol Ther) - P2 | "A population pharmacokinetic-pharmacodynamic model adequately described T cell dynamics after alemtuzumab induction therapy in kidney transplant recipients. This model can be used to inform future dose-optimization studies of alemtuzumab in different clinical settings."

Journal • PK/PD data • Immunology • Infectious Disease • Transplant Rejection • Transplantation

APLASTIC ANAEMIA: 10 YEAR OUTCOMES IN A SOUTH AFRICAN TRANSPLANT CENTRE. (EHA 2025) - "Six haploidentical transplants, using a modified Baltimore regimen with post-transplant Cyclophosphamide, and one matched unrelated donor transplant, using a Busulfan, Melphalan, Fludarabine protocol with Alemtuzumab in the bag were performed. This retrospective study in adult patients with AA demonstrates the superior outcomes of allogeneic stem cell transplantation compared to immunosuppressive and supportive therapy. The transplant group's 1-year survival outcome align with international findings. Although patients under 14 years were excluded, the median treatment age at our centre is significantly lower than reported globally."

Anemia • Aplastic Anemia • Hematological Disorders • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Solid Tumor • Thymoma • Thymus Cancer • Transplantation

A COMPUTATIONAL ANALYSIS OF IMMUNE RECONSTITUTION DYNAMICS IN ADULTS WITH SICKLE CELL DISEASE UNDERGOING HLA-IDENTICAL HEMATOPOIETIC CELL TRANSPLANTATION (EHA 2025) - "SCD is characterized by altered B and T cell homeostasis, which is only partly restored after nonmyeloablative HSCT. Increased naive/transitional and reduced memory B cells likely result from irreversible vaso-occlusive hyposplenia. Increased expression of PD-1 after HSCT is probably due to T cell depleting conditioning with alemtuzumab."

Clinical • IO biomarker • Bone Marrow Transplantation • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Genetic Disorders • Hematological Disorders • Herpes Simplex • Herpes Zoster • Infectious Disease • Pneumococcal Infections • Sickle Cell Disease • Transplantation • Varicella Zoster • CD21 • CD27 • CD4 • CD8 • FOXP3 • PD-1

MAAT033 TO ENSURE OPTIMAL GUT MICROBIOTA TO IMPROVE SURVIVAL IN PATIENTS? RECEIVING ALLOGENEIC HCT: PHOEBUS TRIAL (EHA 2025) - "Exclusion criteria comprise non-myeloablative and conventional myeloablative conditioning regimen in vitro T-cell depletion alloHCT with cord blood cells use of alemtuzumab vedolizumab or abatacept for GvHD prophylaxis and history of chronic digestive disease.Study recruitment is currently ongoing in France Germany Spain Belgium The Netherlands and the UK. The PHOEBUS trial explores for the first time the potential of a full microbiota ecosystem therapy to enhance survival in alloHCT recipients. Recruitment is ongoing and preliminary safety assessments are favorable."

Clinical • Gut Microbiota • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Oncology

COMPARATIVE EFFICACY OF THERAPEUTIC APPROACHES IN RELAPSED/REFRACTORY PERIPHERAL T-CELL LYMPHOMA: A SYSTEMATIC REVIEW AND META-ANALYSIS (EHA 2025) - "This meta-analysis evaluates the efficacy of various therapies for RR-PTCL, including Epigenetic modifiers (HDIs, DNA methyltransferase inhibitors, EZH1/2 inhibitors), Small molecule inhibitors (targeting PI3K/AKT/mTOR, JAK/STAT, ALK, aurora kinase, farnesyl transferase), Combination therapies (various multi-class drug combinations), Pralatrexate-based regimens, monoclonal antibodies (e.g., Pembrolizumab, Alemtuzumab, Zanolimumab, etc.) and Others (Acimtamig, CAR T-cell therapy, etc.). This analysis suggests that combination therapies had the highest response rates, with SMI and pralatrexate-based therapies showing the longest OS. Other cytotoxic chemotherapy-based regimens had the lowest effectiveness, which suggests that combined targeted no-cytotoxic treatment regimens should be further studied in R/R PTCL. Outcomes continue to be poor, and clinical trials with novel treatment strategies should be prioritized"

Retrospective data • Review • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • EZH2

INFECTIOUS COMPLICATIONS OF AGENTS USED IN T-CELL LYMPHOMAS: A DISPROPORTIONALITY ANALYSIS USING THE FAERS DATABASE (EHA 2025) - "The public dashboard of FAERS was queried for reports of infections due to herpes simplex virus (HSV), varicella zoster virus (VZV), cytomegalovirus (CMV), pneumocystis jiroveci (PJP) and cases of hepatitis B (HepB) reactivation and neutropenia associated with mogamulizumab, brentuximab vedotin, vorinostat, romidepsin, praletexate, methotrexate, peginterferon alpha-2a (PEG-IFN alfa-2a) and alemtuzumab when used for the indication of any T-cell lymphoma. Analysis of the FAERS database revealed variability in the reported infectious complications of commonly used agents for TCLs. Among all agents, alemtuzumab had the highest RORs for all infections while vorinostat had statistically significant RORs only for VZV-related infections and neutropenia. Romidepsin, which is a histone deacetylase inhibitor like vorinostat, had RORs that were unexpectedly higher than vorinostat and were comparable with other agents for CMV, HSV and PJP-related infections and neutropenia."

Cutaneous T-cell Lymphoma • Cytomegalovirus Infection • Hematological Disorders • Hematological Malignancies • Hepatitis B • Hepatology • Herpes Simplex • Herpes Zoster • Infectious Disease • Lymphoma • Neutropenia • Oncology • T Cell Non-Hodgkin Lymphoma • Varicella Zoster

CLADRIBINE AND VENETOCLAX FOR TREATMENT OF PATIENTS WITH RELAPSED AND REFRACTORY T-CELL PROLYMPHOCYTIC LEUKEMIA (EHA 2025) - "Second-line treatment with alemtuzumab, pentostatin, or bendamustine results in ORR of 30%-46%...Six pts (38%) received concomitant alemtuzumab and 7 (44%) received ruxolitinib... A backbone of Clad and VEN represents an active combination in pts with R/R T-PLL including those post-allogeneic SCT who otherwise have limited options. An ORR of 56% with a CRi rate of 25% in a heavily pre-treated population compares favorably to what has been reported among relapsed pts. Prospective analysis of this backbone and correlation of response with disease characteristics is warranted."

Clinical • Cardiovascular • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Prolymphocytic Leukemia • BCOR • IL2RG • JAK1 • JAK3 • STAT5B

THREE-MONTH WHOLE BLOOD CHIMERISM INDEPENDENTLY PREDICTS OVERALL SURVIVAL IN ALLOGENEIC STEM CELL TRANSPLANTS FOR HEMATOLOGICAL CANCERS: AN ANALYSIS ON BEHALF OF TWO UK CENTRES (EHA 2025) - "Conditioning regimens incorporated alemtuzumab (n=11 ) antithymocyte globulin (ATG) (n= 1) and post-transplant cyclophosphamide (PTCy) (n= 7). In this two-centre analysis of aSCT for lymphoid and myeloid malignancies full 3-mo BC independently predicted better OS and PFS while full 3-mo TC significantly reduced the CIR at the expense of increased aGVHD and the consequent PFS benefit was lost with longer follow-up. Our findings require further validation as they may inform prospective studies on immunosuppressant tapering or DLI prophylaxis early post-aSCT in high-risk hematological malignancies."

Clinical • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Indolent Lymphoma • Leukemia • Lymphoma • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

THERAPEUTIC OUTCOMES IN T-CELL PROLYMPHOCYTIC LEUKEMIA (T-PLL): A COLLABORATIVE MULTI-CENTER STUDY COHORT AND GENOMIC ANALYSIS (EHA 2025) - "Other active second-line treatments included: pentostatin (without alemtuzumab) (n=28; 43% ORR, 14% CR), ruxolitinib-based regimens (n=4; 25% ORR, 0% CR), venetoclax-based regimens (n=13; 39% ORR, 8% CR), bendamustine (n=19; 27% ORR, 11% CR), and nelarabine (n=4; 75% ORR, 50% CR).In subgroup analysis, TCL1A+ patients had worse OS and PFS when compared to TCL1A- patients (23 vs 42 months; p=0.01), and (14 vs 28 months; p=0.01), with HR 1.54 (1.10, 2.16) (p=0.01) for OS and HR 1.58 (1.13-2.20) (p=0.01) for PFS. In this large multi-center study of T-PLL, frontline treatment with a combination of alemtuzumab/pentostatin improved ORR and OS. Among patients who attained a CR, allograft improved OS & PFS. In relapsed T-PLL, retreatment with alemtuzumab had a high ORR, and we report significant activity of multiple novel/alternative agents with the largest reported numbers to date."

Clinical • Genomic analysis • Omic analysis • Hematological Malignancies • Leukemia • Oncology • Prolymphocytic Leukemia • CD4 • TCL1A

Donor-specific Mesenchymal Stem Cell Infusion in Human and Non-human Primate Kidney Transplantation. (PubMed, Am J Transplant) - P1 | "We report the results of two independent, concurrently performed studies evaluating the safety and efficacy of donor-derived mesenchymal stromal cell (MSC) infusions in inducing immune-tolerance in nonhuman primate (NHP) and human kidney transplant recipients treated with depletional induction and belatacept/sirolimus maintenance...In humans, six patients enrolled in ITN062ST underwent transplantation with alemtuzumab induction; four received 12 monthly donor-MSC infusions followed by immunosuppression withdrawal (ISW) if eligible...Trial Registration. ClinicalTrials.gov - NCT03504241."

Journal • Transplantation

Addition of Thiotepa to Alemtuzumab, Fludarabine, and Melphalan Reduced-Intensity Conditioning Reduces Secondary Graft Failure in Allogeneic HSCT for Inborn Errors of Immunity (CIS 2025) - "Addition of thiotepa to a RIC regimen containing fludarabine, alemtuzumab, and melphalan reduces secondary graft failure without increasing toxicity in children and young adults undergoing allogenic HSCT for IEI. Longer duration of follow-up is needed to assess durability of donor chimerism."

Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hepatology • Immunology • CD34 • XIAP

Peripheral T- and natural killer-cell lymphomas: ESMO–EHA Clinical Practice Guideline for diagnosis, treatment and follow-up (ESMO.org) - "r/r ALK-positive ALCL- BV is recommended in patients who did not receive first-line BV or those with late relapse after an initial response [III, A]; For patients refractory to BV, ALK inhibitors such as crizotinib (EMA and FDA approved in children and young adults), alectinib (not EMA or FDA approved), brigatinib (not EMA or FDA approved) or ceritinib (not EMA or FDA approved) should be considered [III, A]. ChT (e.g. ICE, DHAP or IVAC–MTX) is also an option [III, B]...r/r ENKTCL- If available, an anti-PD-1 antibody such as pembrolizumab (not EMA or FDA approved) or nivolumab (not EMA or FDA approved) can be considered as monotherapy or in combination with gemcitabine and/or L-asparaginase or crisantaspase [III, B]...r/r T-PLL- Alemtuzumab–pentostatin is recommended after a treatment-free period of ≥6 months in patients who still have CD52-postive tumour cells [III, A; not EMA or FDA approved]."

Clinical guideline • Anaplastic Large Cell Lymphoma • Extranodal Natural Killer/T-cell Lymphoma • Peripheral T-cell Lymphoma

Platelet Refractory Thrombocytopenia during Hematopoietic Cell Transplant from Alloantibody Formation to Platelet CD36 (ASPHO 2025) - "Objectives: To describe the detection and management of PTR secondary to CD36 alloantibodies in a patient undergoing HCT Design/ Case report A 15-year-old Nigerian male, with hemoglobin SS disease complicated by stroke on chronic transfusions for secondary prophylaxis received a matched sibling HCT conditioned with myeloablative busulfan, fludarabine, and alemtuzumab. Blood centers in geographical areas with a low frequency of CD36-negative population may not be able to support the demand for platelets in patients of African and Asian descent with CD36-negative platelets undergoing HCT or GT, putting them at risk for life-threatening bleeding. This case shows the importance of proactively identifying patients with CD36-negative platelets prior to initiating curative therapies, in order to develop a plan to support them during their platelet transfusion needs and prevent the development of alloimmunization."

Beta-Thalassemia • Cardiovascular • Gene Therapies • Genetic Disorders • Hematological Disorders • Infectious Disease • Malaria • Sickle Cell Disease • Thrombocytopenia • Transplantation • CD36 • SCARB1

Identification of non-virologic risk factors for lymphoma after the first year of kidney transplant in adults: A retrospective analysis. (PubMed, Cancer Epidemiol) - "Non-virologic risk factors including KTRs advanced age or male sex, prior cancer or KT, alemtuzumab induction, ECD transplant, and acute rejection are associated with PTL beyond the first post-KT year."

Journal • Retrospective data • Diabetic Nephropathy • Hematological Malignancies • Lymphoma • Nephrology • Oncology • Renal Disease • Transplant Rejection • Transplantation

Base Editing Hematopoietic Stem Cell Gene Therapy for CD40L-HyperIgM Syndrome: Single Patient Study (clinicaltrials.gov) - P1/2 | N=1 | Enrolling by invitation | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

New P1/2 trial • Gene Therapies • Immunology • Primary Immunodeficiency • CD40LG

Hematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic Anemia (clinicaltrials.gov) - P=N/A | N=61 | Completed | Sponsor: Masonic Cancer Center, University of Minnesota | Active, not recruiting ➔ Completed | Trial completion date: Jul 2026 ➔ Mar 2025

Trial completion • Trial completion date • Anemia • Aplastic Anemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Transplantation • DKC1 • TERT

Exacerbation of Orbitopathy After Total Thyroidectomy in Alemtuzumab-Induced Graves' Disease: A Case Report (ESPE-ESE 2025) - "Treatment with thiamazole and propranolol was initiated with partial symptom improvement...Due to only partial improvement, treatment with Tocilizumab has been proposed and is scheduled to begin soon... A patient with severe, difficult-to-control hyperthyroidism and moderate-to-severe inactive orbitopathy underwent total thyroidectomy. Despite this, orbitopathy exacerbation occurred post-surgery, requiring specific treatment. This case highlights a rare complication and raises the question of whether corticosteroid prophylaxis should be considered after surgery in high-risk patients."

Case report • Clinical • CNS Disorders • Dry Eye Disease • Endocrine Disorders • Grave’s Disease • Inflammation • Multiple Sclerosis • Ophthalmology • Pain • Thyroid Eye Disease

Growth Failure and Chondrodysplasia Following Early Hematopoietic Stem Cell Transplantation for Familial Lymphohistiocytosis: A Case Report (ESPE-ESE 2025) - "Initial treatment with corticosteroids, cyclosporine, and alemtuzumab failed to induce remission, resulting in an HSCT. (2020), who described a series of 7 children with similar growth failure and radiographic changes after HSCT for non-oncologic pediatric diseases, suggesting a new potential complication. This case highlights the importance of careful monitoring of growth and skeletal development in children undergoing HSCT for non-oncologic conditions, as they may be at risk for both endocrine and skeletal complications."

Case report • Clinical • Bone Marrow Transplantation • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Immunology • Orthopedics • Pediatrics • Rare Diseases • Transplantation • IGF1 • IGFBP3 • PRF1

Experience with T Cell–Depleted Allogeneic HSCT for Refractory sJIA Associated with Lung Disease (CIS 2025) - " We report our single-center retrospective analysis of 4 pediatric patients with sJIA-LD who underwent allogeneic HSCT with reduced intensity conditioning (RIC) with alemtuzumab (days 14-12), fludarabine (150 mg/2 over days -8 to -4), melphalan (140 mg/m 2 on day -3), and thiotepa (200 mg/m 2 on day -2) and received either a CD34+-selected (n = 3) or TCR-αβ– depleted (n = 1) peripheral blood stem cell product...One patient experienced secondary graft failure on day +43 requiring a second HSCT with a haploidentical parental donor and post-transplant cyclophosphamide (Table 1)... Our experience suggests that allogeneic HSCT with a T cell– depleted approach for patients with sJIA-LD offers durable engraftment with low risk of GVHD, pulmonary complications, and TRM."

Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Idiopathic Arthritis • Immunology • Inflammation • Pediatrics • Pneumonia • Pulmonary Disease • Respiratory Diseases • Rheumatology • CD34 • IL18

ORAL ABSTRACT Precision Alemtuzumab Dosing Results in Day 0 Target Range Achievement in 80% of IEI Patients and Minimizes Risks of GVHD, Clinically Significant Mixed Chimerism, and Secondary Graft Failure (CIS 2025) - "Sixteen patients received fludarabine, melphalan, and thiotepa, and 4 patients received busulfan and fludarabine in addition to alemtuzumab. Precision alemtuzumab dosing is feasible and results in target range achievement in 80% of patients compared with only approximately 25% of patients treated with standard-of-care alemtuzumab dosing regimens. Use as part of reduced toxicity conditioning approaches appears to result in low rates of acute GVHD, clinically significant mixed chimerism, and secondary graft failure at Day +100."

Clinical • Late-breaking abstract • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

Targeting EBV-infected T cells with alemtuzumab: a novel approach to systemic chronic active EBV disease. (PubMed, Int J Hematol) - "The conditioning regimen consisted of fludarabine (25 mg/m2, Days  - 7 to  - 3), melphalan (40 mg/m2, Days  - 3 to  - 2), and total body irradiation (TBI, 4 Gy, Day  - 1)...Cyclosporine was given from Day  - 1, and short-term methotrexate was given on Days 1, 3, and 6. The transplantation was successful, with no GVHD or severe infections. Earlier administration of alemtuzumab may not only reduce prolonged post-transplant immunosuppression but also speed up elimination of EBV-infected cells before transplantation for sCAEBV."

Journal • Bone Marrow Transplantation • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Infectious Disease • Transplantation • CD4 • CD52

CRISPR/Cas9 enables efficient knockout of CD52 without CD3/CD28 in expanded CMV-specific T cells (ASGCT 2025) - "Alemtuzumab, a lymphodepleting monoclonal antibody that targets the surface antigen CD52, is commonly used as a conditioning regimen to prevent the development of graft versus host disease (GVHD)...This demonstrates the feasibility of CD52 KO with peptide stimulated T cells in absence of CD3/CD28 and could facilitate production of "next generation" gene-edited VST product to restore antiviral immunity early post HSCT alongside prevention of GVHD. Disease Focus of Abstract:Immunodeficiency"

Bone Marrow Transplantation • Cytomegalovirus Infection • Graft versus Host Disease • Immunology • Infectious Disease • Oncology • CD52 • IL2 • IL4 • IL7

Alemtuzumab-Resistant Virus-Specific T (VST) Cells Developed for the Prevention of Viral Infections After Hematopoietic Stem Cell Transplantation Retain Antiviral Activity In-Vivo and In-Vitro (ASGCT 2025) - "Long term persistence and antiviral function of cells in-vivo, as well as multiviral CD52-KO VSTs are being investigated with the eventual intent to create a readily available CD52-KO VST that can fight infection while resisting T cell depletion after HSCT. Disease Focus of Abstract:Immunodeficiency"

IO biomarker • Preclinical • Virus specific T cells • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Transplantation • CD52 • IFNG • TNFA

Alemtuzumab-Induced Thyroid Eye Disease: Case Series (ENDO 2025) - "Both patients were treated with lubricant eye drops, selenium, and intravenous methylprednisolone, with one requiring Mycophenolate Mofetil (MMF) and Azathioprine as second-line agents before achieving remission. As the use of Alemtuzumab in managing MS increases, the incidence of Al-TED is likely to rise. Al-TED can develop several years after treatment, necessitating a high index of suspicion for timely diagnosis, particularly in cases of mild disease. The potential for significant morbidity in moderate to severe TED underscores the importance of early recognition and appropriate treatment.*."

Clinical • CNS Disorders • Endocrine Disorders • Grave’s Disease • Multiple Sclerosis • Ocular Inflammation • Ophthalmology • Thyroid Eye Disease • CD52

Inhibition of platelet activation and antibody-dependent cellular cytotoxicity by the tyrosine kinase inhibitor dasatinib in an ex vivo human whole blood system (AACR 2025) - "At the Cmax concentration, alemtuzumab (anti-CD52) results in antibody-dependent cellular cytotoxicity (ADCC) and release of large amounts of cytokines in the test system, mimicking clinical effects of the drug. Taken together, the data suggest that the ex vivo test system can be used to investigate the effect of different therapeutic agents on platelet activation and that dasatinib at concentrations that inhibit platelet activation may also inhibit ADCC. Combination therapies involving dasatinib and antibodies with predicted ADCC-dependent effects may thus require further investigation prior to clinical use."

Preclinical • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR • SELP