Granocyte (lenograstim) / Roche - LARVOL DELTA

INFANTS AND YOUNG CHILDREN PERIPHERAL BLOOD STEM CELL COLLECTION FOR EX-VIVO HEMATOPOIETIC STEM CELL GENE THERAPY: FEASIBILITY AND EFFICACY IN 37 PATIENTS WEIGHING 7-15 KG (EBMT 2025) - "Mobilization stimulation included lenograstim (5 μg/kg) every 12 hours for at least three days, followed by plerixafor (0.24 mg/kg) 4-6 hours before collection, dose-adjusted on white blood cell count (WBC). PBSC collection is safe in infants and young children and high CD34+ target can be achieved (>30 x10⁶/kg), including in those weighting less than 10 kg. Preliminary activities for HSC-GT, such as mobilization and PBSC collection, can be safely initiated soon after diagnosis of inborn errors disorders, even in the first few months of life."

Gene therapy • Preclinical • Anesthesia • Cardiovascular • Gene Therapies • Hematological Disorders • Immunology • Infectious Disease • Metabolic Disorders • Pediatrics • Primary Immunodeficiency • Venous Thromboembolism • CD34

INFANTS AND YOUNG CHILDREN PERIPHERAL BLOOD STEM CELL COLLECTION FOR EX-VIVO HEMATOPOIETIC STEM CELL GENE THERAPY: FEASIBILITY AND EFFICACY IN 37 PATIENTS WEIGHING 7-15 KG (EBMT 2025) - "Mobilization stimulation included lenograstim (5 μg/kg) every 12 hours for at least three days, followed by plerixafor (0.24 mg/kg) 4-6 hours before collection, dose-adjusted on white blood cell count (WBC). PBSC collection is safe in infants and young children and high CD34+ target can be achieved (>30 x10⁶/kg), including in those weighting less than 10 kg. Preliminary activities for HSC-GT, such as mobilization and PBSC collection, can be safely initiated soon after diagnosis of inborn errors disorders, even in the first few months of life."

Gene therapy • Preclinical • Anesthesia • Cardiovascular • Gene Therapies • Hematological Disorders • Immunology • Infectious Disease • Metabolic Disorders • Pediatrics • Primary Immunodeficiency • Venous Thromboembolism • CD34

NESC: Neoadjuvant Treatment of Gastric Adenocarcinoma (clinicaltrials.gov) - P2 | N=34 | Completed | Sponsor: Recherche clinique | Unknown status ➔ Completed

Trial completion • Gastric Adenocarcinoma • Gastric Cancer • Oncology • Solid Tumor

Predicting apheresis yield and factors affecting peripheral blood stem cell harvesting using a machine learning model. (PubMed, J Int Med Res) - "We used machine learning methods to identify and validate Mono%, age, and CD34+ cell% as significant factors predictive of successful PBSC harvest on the first attempt, offering important insight to guide the clinical harvesting of PBSCs."

Journal • Machine learning • Retrospective data • CD34

A Randomized Comparison of CPX-351 and FLAG-Ida in Patients with High-Risk Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) and MDS-Related Gene Mutations: A Subgroup Analysis of the UK NCRI AML19 Trial (ASH 2024) - "FLAG-Ida consisted of fludarabine 30 mg/m2 and cytarabine 2 g/m2 on days 2-6 (reduced to 1 g/m2 in patients >60 years), lenograstim 263 µg on days 1-7, and idarubicin 8 mg/m2 on days 4-6; consolidation regimens were MACE-MiDAC...A more favorable toxicity profile may have resulted in higher number of patients in CPX-351 arm getting to transplant. Post-transplant OS was longer with CPX-351 compared with FLAG-Ida."

Clinical • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • Septic Shock • Thrombocytopenia • ASXL1 • BCOR • RUNX1 • SF3B1 • SRSF2 • STAG2 • TP53 • U2AF1 • ZRSR2

Transendocardial injection of expanded autologous CD34+ cells after myocardial infarction: Design of the EXCELLENT trial. (PubMed, ESC Heart Fail) - "Autologous CD34+ cell therapy is currently limited by technological constraints. This is the first trial to evaluate the feasibility and potential effect of CD34+ cells after automated expansion and transendocardial administration in patients with large AMI."

Journal • Cardiovascular • Myocardial Infarction • CD34

Effect of Granulocyte Colony Stimulating Factor (GCSF) on Survival in Patients with Acute Myeloid Leukemia (AML) (ASH 2024) - "The population was further divided into two groups, based on the receipt of GCSF (filgrastim, pegfilgrastim, lenograstim, eflapegrastim) within 6 months of diagnosis. Overall survival was also shorter for patients who received GCSF. GCSF should be used very diligently in AML cases."

Acute Myelogenous Leukemia • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Septic Shock

Comparative Efficacy and Safety of Lenograstim Versus Filgrastim for Hematopoietic Stem Cell Mobilization in Autologous Hematopoietic Stem Cell Transplantation: A Systematic Review (APBMT 2024) - No abstract available

Clinical • Review • Bone Marrow Transplantation • Transplantation

Continuous Versus Bolus Administration of G-CSF in Children With Cancer (clinicaltrials.gov) - P4 | N=20 | Active, not recruiting | Sponsor: Chang Gung Memorial Hospital | Recruiting ➔ Active, not recruiting | N=40 ➔ 20

Enrollment change • Enrollment closed • Hematological Disorders • Hematological Malignancies • Neutropenia • Oncology • Pediatrics

Forty years of human G-CSF: A short history in time. (PubMed, Br J Haematol) - "In 1987, clinical trials began using recombinant G-CSF in cancer patients following chemotherapy to reduce the duration of neutropenia and in patients with congenital neutropenia (CN) to increase the number of neutrophils. It has changed the quality of life for many cancer patients and saved the lives of many patients with (CN)."

Journal • Review • Chemotherapy-Induced Neutropenia • Hematological Disorders • Neutropenia • Oncology

A case of large vessel vasculitis caused by Pegfilgrastim during neoadjuvant chemotherapy for breast cancer (JBCS 2024) - "Docetaxel was administered as preoperative chemotherapy, and pegfilgrastim was administered on day 4 of the first course...(Discussion) In recent years, there have been sporadic reports of large vasculitis due to G-CSF preparations, and in June 2018, 16 cases of pegfilgrastim, 2 cases of Filgrastim, and 2 cases of Lenograstim were reported in the past 3 years, and the Ministry of Health, Labor and Welfare instructed that large vasculitis be added as a serious side effect of G-CSF preparations. In some cases, drug-induced vasculitis improves naturally by simply stopping the drug, but there have also been reported cases in which aortic dissection developed despite steroid treatment. When fever of unknown cause occurs during chemotherapy, it is necessary to keep in mind the possibility of large vessel vasculitis caused by G-CSF preparations, and to proactively perform contrast CT scans, etc., in order to quickly make a definitive diagnosis"

Clinical • Breast Cancer • Fatigue • Febrile Neutropenia • Hematological Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Neutropenia • Oncology • Otorhinolaryngology • Pain • Rheumatology • Solid Tumor • Triple Negative Breast Cancer • Vasculitis

A RANDOMIZED COMPARISON OF CPX-351 AND FLAG-IDA IN HIGH-RISK MYELODYSPLASTIC SYNDROME (MDS): A SUBGROUP ANALYSIS OF UK NCRI AML19 (EHA 2024) - "FLAG-Idaconsisted of fludarabine 30 mg/m2 and cytarabine 2g/m2 on days 2–6 (reduced to 1 g/m2 in patients >60years), lenograstim 263 µg on days 1–7, and idarubicin 8 mg/m2 on days 4–6; consolidation regimens wereMACE-MiDAC... This exploratory analysis suggests a survival advantage with CPX-351 compared with FLAG-Ida in adult patientswith newly diagnosed high-risk MDS. Future studies with larger patient numbers are needed to confirm thesefindings."

Clinical • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

HIGHDOSE CHEMOTHERAPY AND TRANSPLANTATION OF 34+ SELECTED STEM CELLS FOR PROGRESSIVE SYSTEMIC SCLEROSIS WITH OR WITHOUT CARDIAC INVOLVEMENT OR ALVEOLITIS - MODIFICATION ACCORDING TO MANIFESTATION (AST MOMA) (EULAR 2024) - "Patients were eligible if they were between 18 -65 years old, had a limited (lc) or diffuse cutaneous (dc)SSc with a disease duration of ≤ 6 years and a progressive disease despite cyclophosphamide (CYC) pre-treatment...Mobilization was conducted with 2x1000mg/m 2 CYC + lenograstim...Patients with functional heart involvement received a conditioning regimen with thiotepa (2x5mg/kg), half dose of CYC (2x50mg/kg) and rATG (4x10mg/kg) before reinfusion of the CD34+ selected stem cells... The COVID pandemic led to a prolonged recruitment period with many screening failures or late drop outs. The primary endpoint was reached and the overall survival rate after 3 years was comparable to available data [2]. The TRM rate of 11.4% is higher than we expected, but probably attributed to a high-risk population, as >50% were male, >50% had functional cardiac involvement, and >90% were anti-Scl70 positive and >90% dcSSc patients."

Bone Marrow Transplantation • Immunology • Inflammation • Novel Coronavirus Disease • Scleroderma • Systemic Sclerosis • Transplantation • CD34

Cost-effectiveness analysis of granulocyte colony-stimulating factors for the prophylaxis of chemotherapy-induced febrile neutropenia in patients with breast cancer in Taiwan. (PubMed, PLoS One) - "Our study suggests that primary prophylaxis with either short- or long-acting G-CSF could be considered cost-effective for FN prevention in breast cancer patients receiving high-risk regimens."

Cost effectiveness • HEOR • Journal • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Balancing Benefits and Risks: A Literature Review on Hypersensitivity Reactions to Human G-CSF (Granulocyte Colony-Stimulating Factor). (PubMed, Int J Mol Sci) - "Immediate ones were mostly caused by filgrastim (13 minimum), with at least 9 being grade 5 on the WAO anaphylaxis scale...Only five desensitization protocols have been found concerning the topic at hand in the analyzed data. We believe this study brings to light the research interest in this topic that could benefit from further exploration, and propose regular updating to include the most recently published evidence."

Journal • Review • Allergy • Hematological Disorders • Immunology • Neutropenia • Transplantation

Aortitis after switching short-acting granulocyte colony-stimulating factors in a lymphoma patient with HLA-B52. (PubMed, Int J Hematol) - "The aortitis was triggered by filgrastim and recurred after treatment with lenograstim. Our case suggests that switching from one short-acting G-CSF to another does not prevent recurrence of G-CSF-associated aortitis. Although the etiology of G-CSF-associated aortitis has not been fully elucidated, our case also suggests that some patients may be genetically predisposed to aortitis."

Journal • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Vasculitis

EMEG-ECDD: Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Centre Georges Francois Leclerc | Trial completion date: Apr 2024 ➔ Oct 2025 | Trial primary completion date: Apr 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

A MACROPHAGES-BASED IMMUNOTHERAPY OF SOLID TUMORS MICROENVIRONMENT: PRELIMINARY RESULTS OF THE TEM-GBM_01 STUDY (EBMT 2024) - P1/2 | "Autologous CD34+ HSPC are mobilized with lenograstim and plerixafor, collected by apheresis, purified and ex vivo modified with a lentiviral vector. Following a sub-myeloablative conditioning regimen (Thiotepa + BCNU or Thiotepa + Busulfan or Busulfan alone), up to 3 million Temferon cells/kg are administered following a fixed dose of non-manipulated CD34+ supporter cells As of 27th July 2023, 21 GBM patients in 7 cohorts received incremental doses of Temferon up to 3 million cells/kg and 5 patients were still alive with a median OS of 17 months and a median PFS of 8.3 months following initial surgery... These data corroborate the initial evidence on safety and tolerability of Temferon. They also suggest that Temferon has potential to counteract disease progression in patients affected by unmethylated MGMT GBM"

IO biomarker • Brain Cancer • CNS Tumor • Febrile Neutropenia • Glioblastoma • Glioma • Hematological Disorders • Infectious Disease • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • Transplantation • CD34 • IFNA1 • MGMT

LENOGRASTIM AND FILGRASTIM: REAL-LIFE COMPARISON IN MOBILIZATION OF ALLOGENEIC HEMATOPOIETIC STEM CELL DONORS (EBMT 2024) - "However, day 4 CD34+ cells were significantly higher in the filgrastim-treated group, both as absolute count (median: lenograstim 37/μl, filgrastim 50/μl, p 0.0069) and as percentage over WBC count (median: lenograstim 0.09%, filgrastim 0.11%, p 0.03).Donors were classified as poor mobilizer at day 4 if CD34+ were <20/μl and plerixafor was administered on-demand on day 5 to 10 donors, in an equal fraction in the two groups (lenograstim 9/526, filgrastim 1/62, p 0.94); these donors were excluded from day 5 counts analysis as only post-plerixafor counts were available.At day 5, there were no differences in WBC count (median: lenograstim 45200/μl, filgrastim 44800/μl, p 0.88) or platelet count (median: lenograstim 206000/μl, filgrastim 214000/μl, p 0.6). Lenograstim and filgrastim have comparable effects on WBC and platelet counts at day 4 and 5 of administration. Day 4 CD34+ cells counts are higher during filgrastim treatment, but this difference decreases at day 5,..."

Clinical • CD34

NON-CRYOPRESERVED PERIPHERAL BLOOD STEM CELL AUTOLOGOUS TRANSPLANTATION FOR MULTIPLE MYELOMA AS A SAFE ALTERNATIVE IN COUNTRIES WITH LOW RESOURCES: A NINE-YEARS OF BICENTRIC EXPERIENCE (EBMT 2024) - " We conducted a retrospective bicentric study with all newly diagnosed MM patients who underwent PBSCT without cryopreservation in the clinical hematology department of the Mohammed V military hospital and at the Al Madina Clinic,between January 1,2015 and December 15, 2023.In our context,AHSCT is not proposed to patients >70years old,those with a cardiac ejection fraction less than 50%,or to patients with liver failure,progressive viral hepatitis.Incomplete files were removed from the study.PBSC were mobilized with lenograstim alone or in association with plerixafor depending on the number of CD34+ cells circulating in peripheral blood counted on the fourth day after the start of mobilization.The stem cells collected were stored for 24-48hours in a blood bank refrigerator at a temperature of 4°C.After standard conditioning with high-dose Melphalan,peripheral blood stem cells were reinjected 24h after conditioning. Non-cryopreserved autologous grafts are..."

Bone Marrow Transplantation • Cardiovascular • Dermatology • Febrile Neutropenia • Gastrointestinal Disorder • Hematological Malignancies • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Liver Failure • Mucositis • Multiple Myeloma • Nephrology • Neutropenia • Novel Coronavirus Disease • Oncology • Pancreatitis • Respiratory Diseases • Thrombocytopenia • Transplantation • CD34

Genetic Engineering of Hematopoietic Progenitor Stem Cells for Targeted IFN-α Immunotherapy Reprogramming the Solid Tumor Microenvironment: A First-in-Man Study in Glioblastoma Multiforme (NCT03866109) (ASH 2023) - P1/2 | "Autologous CD34+ HSPC are mobilized with lenograstim and plerixafor, collected by apheresis, purified and ex vivo modified with a lentiviral vector. So far, up to 3 million Temferon cells/kg have been co-administered with a fixed dose of non-manipulated CD34+ supporter cells following a sub-myeloablative conditioning regimen (Thiotepa + BCNU or Busulfan or Busulfan alone)... These data show that Temferon is safe and biologically active at the tumor site and favors anti-tumor immunity. The results provide initial evidence of Temferon's potential to modulate the TME of GBM patients and to counteract disease progression and improve the survival of uMGMT GBM patients."

Biomarker • IO biomarker • Tumor microenvironment • Brain Cancer • CNS Tumor • Gene Therapies • Glioblastoma • Oncology • Solid Tumor • CD34 • CD8 • IFNA1 • MGMT • PTPRC

Continuous Versus Bolus Administration of G-CSF in Children With Cancer (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: Chang Gung Memorial Hospital

New P4 trial • Hematological Disorders • Hematological Malignancies • Neutropenia • Oncology • Pediatrics

CARDIOSTEM: Donation of Whole Blood by Healthy Volunteers After Mobilisation by Haematopoietic Growth Factor (Rhu-G-CSF = Granocyte) (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: CellProthera | Trial completion date: Jan 2024 ➔ Jan 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • CD34

NESC Multicenter Phase II Trial in the Preoperative Treatment of Gastric Adenocarcinoma with Chemotherapy (Docetaxel-Cisplatin-5FU + Lenograstim) Followed by Chemoradiation (CRT) Based 5FU and Oxaliplatin and Surgery. (PubMed, Cancer Res Treat) - P2 | "Among resected patients, those whose histological response was TRG1-2 had a significantly better OS and progression-free survival (PFS) rates than those with a TRG 3-4-5 response (p=0.019 and p=0.016 respectively). Promising results from trials involving preoperative chemoradiation followed by surgery in gastric cancer need to be further evaluated in a Phase III trial."

Journal • P2 data • Surgery • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

EMEG-ECDD: Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Centre Georges Francois Leclerc | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2023 ➔ Apr 2024 | Trial primary completion date: Apr 2023 ➔ Apr 2024

Enrollment open • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor