Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche - LARVOL DELTA

SWOG S1826: Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma (clinicaltrials.gov) - P3 | N=994 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Apr 2025 ➔ Mar 2026

Trial completion date • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Association Between Baseline Neutrophil Count and Febrile Neutropenia Following Docetaxel and Ramucirumab With Prophylactic Pegfilgrastim. (PubMed, Thorac Cancer) - "Our data showed the incidence rate of FN receiving DTX + RAM with prophylactic pegfilgrastim was 5.5%. Despite prophylactic pegfilgrastim, BNC was correlated with LNC and might be predictive of FN. We should be careful of BNC even if it meets the criteria for starting DTX + RAM treatment."

Journal • Retrospective data • Cardiovascular • Febrile Neutropenia • Hematological Disorders • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: University of Washington | Initiation date: Jun 2025 ➔ Sep 2025

Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (clinicaltrials.gov) - P3 | N=244 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

Large vessel vasculitis associated with atezolizumab. (PubMed, BMJ Case Rep) - "Existing literature has documented large vessel vasculitis in association with ipilimumab, pembrolizumab and nivolumab therapy. Although large vessel vasculitis was reported in one patient who had received both atezolizumab and pegfilgrastim, our patient represents the first instance of large vessel vasculitis associated with atezolizumab alone. Discontinuation of atezolizumab and tapered glucocorticoid therapy resulted in clinical and radiographic resolution."

Journal • Gastric Cancer • Hematological Disorders • Immunology • Myositis • Oncology • Rheumatology • Solid Tumor • Vasculitis

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1 | N=54 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4

Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Yeon Hee Park | Initiation date: Jan 2025 ➔ Jun 2025

Trial initiation date • Breast Cancer • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer

Case of Fatal Oxaliplatin-induced Pulmonary Toxicity (ATS 2025) - "Various chemotherapy agents are known to cause pulmonary toxicity such as bleomycin, busulfan, cyclophosphamide and actinomycin-D...CASE PRESENTATION: A 78-year-old woman with stage 3A serous cystadenoma ovarian cancer had previously undergone a total abdominal hysterectomy with bilateral salpingo-oophorectomy, followed by six cycles of carboplatin and paclitaxel, remaining recurrence-free...FOLFOXIRI/pegfilgrastim (folinic acid, 5-fluorouracil, oxaliplatin, irinotecan) was initiated, but due to oral blisters and ulcers, a 20% dose reduction was implemented in the second cycle...Treatment with intravenous immunoglobulin (IVIG), antibiotics, Rituximab, and ARDS protocol was ineffective, leading to ARDS, renal failure, and multi-organ failure...Few patients showed improvement with oxaliplatin discontinuation, while others responded to glucocorticoids, N-acetylcysteine (NAC), cyclophosphamide, and IVIG...We recommend monitoring patients with underlying pulmonary disease..."

Clinical • Acute Respiratory Distress Syndrome • Colorectal Cancer • Gynecology • Immunology • Interstitial Lung Disease • Oncology • Ovarian Cancer • Pain • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Pneumonia • Pulmonary Disease • Renal Disease • Respiratory Diseases • Solid Tumor

High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=17 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Apr 2025 ➔ Apr 2026 | Trial primary completion date: Apr 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Trends of the use of pegylated granulopoiesis growth factors in clinical practice - single oncology centre experience since 2005. (PubMed, Klin Onkol) - "In 2019, compared to 2005-2010, we show an increase in the use of PGCSF with a shift to palliative CHT protocols and generally less risky for the development of FN. The efficacy and safety of PGCSF were consistent with the conclusions of published studies. More detailed analyses of indications for Q2W protocols, generally low-risk or infrequent non-standard situations can bring other important insights and are topics for ideally multicenter cooperation."

Journal • Retrospective data • Allergy • Febrile Neutropenia • Gastrointestinal Cancer • Hematological Disorders • Immunology • Leukopenia • Musculoskeletal Diseases • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Solid Tumor • EGFR

Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies (clinicaltrials.gov) - P2 | N=48 | Completed | Sponsor: Washington University School of Medicine | Active, not recruiting ➔ Completed | Trial completion date: Jun 2025 ➔ Nov 2024

Trial completion • Trial completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Cost-Effectiveness of Pegfilgrastim Versus 5-day Filgrastim in Early Breast Cancer Patients Undergoing Neoadjuvant and Adjuvant Chemotherapy: A Trial-Based Economic Evaluation (ISPOR 2025) - "PEG was associated with fewer hospitalizations, comparable FN incidence, and similar QLAYs compared to 5-day FIL, suggesting it may be the preferred option for EBC patients. A cost-effectiveness analysis is ongoing."

Clinical • Cost effectiveness • HEOR • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

WHIM Syndrome Diagnosis in a Parent and Child (CIS 2025) - "Mavorixafor was started and pegfilgrastim discontinued with no sinopulmonary infections or hospitalizations since initiation. However, skin rashes worsened, and he developed an axillary abscess requiring trimethoprim-sulfamethoxazole and cephalexin therapy...PIDs with milder phenotypes are often not considered in adult patients until severe manifestations occur, as seen in Case 1. Diagnosis of PIDs should prompt early immune evaluation with consideration of genetic testing in family members."

Clinical • Dermatology • Immunology • Infectious Disease • Otorhinolaryngology • Pneumococcal Infections • Pneumonia • Primary Immunodeficiency • Respiratory Diseases • Tetanus • CD4 • CD8 • CXCR4

Granulocyte colony-stimulating factor-associated aortitis in a man with advanced prostate cancer. (PubMed, IJU Case Rep) - "We present a case of G-CSF-associated aortitis in a 70-year-old male with stage IVb castration-resistant prostate cancer (cT3bN0M1b) receiving docetaxel chemotherapy...Daily prednisone treatment (equivalent to 25 mg prednisolone) was initiated on the following day. Although the initial episode of aortitis resolved within 5 weeks, subsequent pegfilgrastim resulted in recurrence around the left subclavian artery, necessitating further steroid therapy. Persistent high fever following G-CSF administration may indicate drug-induced aortitis, highlighting the potential for aortitis recurrence with repeated G-CSF use."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Neutropenia • Oncology • Prostate Cancer • Solid Tumor

PEGFILGRASTIM VS. FILGRASTIM FOR FEBRILE NEUTROPENIA PREVENTION IN THE FIRST CYCLE OF POLATUZUMAB VEDOTIN-R-CHP (POLA-R-CHP): A NATIONWIDE COHORT STUDY IN NEWLY DIAGNOSED DIFFUSE LARGE B-CELL LYMPHOMA (EHA 2025) - "The phase 3 POLARIX trial demonstrated that pola-R-CHP improved progression-free survival compared to R-CHOP. Pegfilgrastim had a lower FN incidence and a shorter hospital stay compared to filgrastim in newly diagnosed DLBCL patients receiving the first cycle of pola-R-CHP."

B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology

ETOPOSIDE+CYTARABINE+PEGFILGRASTIM VS CYCLOPHOSPHAMIDE+GRANULOCYTE COLONY-STIMULATING FACTOR FOR STEM-CELL MOBILIZATION IN PATIENTS WITH MULTIPLE MYELOMA: A PHASE III TRIAL (EHA 2025) - P3 | "Using a stratified block randomization technique, adults with recently diagnosed MM were randomized in a 2:1 ratio to either the experimental (EAP) or control (CG) groups, based on their previous exposure to lenalidomide (>4 cycles vs. ≤4 cycles). Higher percentages of patients reached optimum and target thresholds after fewer apheresis sessions, indicating that EAP was more effective than CG in generating optimal HSC yields. It had tolerable toxicity and an acceptable safety profile. The low usage of plerixafor highlights EAP's independence and points to it as a potential first-line mobilization regimen for MM patients, especially those who are unable to take plerixafor."

P3 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia • CD34

Impact of single dose of pegfilgrastim on peripheral blood stem cell harvest in patients with multiple myeloma or malignant lymphoma. (PubMed, Sci Rep) - P2 | "The plerixafor administration rates in the MM cohort were 50.0% and 63.3% in the pegfilgrastim and filgrastim groups, respectively, and 91.7% in the ML cohort. There were no major differences in safety measures between the two groups. Although the sample size was small, particularly in the ML cohort, a single dose of pegfilgrastim demonstrated comparable efficacy and safety to daily doses of filgrastim, indicating its potential for clinical use while reducing patient burden.Trial Registration: jRCT2011210029, NCT05007652."

Clinical • Journal • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology • CD34

Is it appropriate to select patients for primary prophylactic use of pegfilgrastim based on the risk of febrile neutropenia? (PubMed, Support Care Cancer) - "These results indicate that the current approach to select patients for primary prophylactic use of pegfilgrastim by evaluating existing FN risk factors may not be appropriate for individual patient assessment."

Clinical • Journal • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Comparing Filgrastim and Pegfilgrastim for Primary Prophylaxis of Febrile Neutropenia in Early Breast Cancer: A real-world study (ESMO-BC 2025) - "Background: Dose-dense doxorubicin and cyclophosphamide (ddAC), used in early breast cancer (EBC), has a 10-20% risk of febrile neutropenia (FN), a serious complication of chemotherapy (CT)...Paclitaxel after ddAC was used in 71%, pembrolizumab in 16% and carboplatin in 25%... While no significant difference in FN rates was observed, pegfilgrastim was linked to higher rates of neutropenia and more frequent treatment delays and dose reductions, resulting in reduced dose-density. Since dose-density is crucial for treatment efficacy and FN risk remains a key consideration, further research is warranted to validate these findings."

Clinical • Real-world • Real-world evidence • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

EMPEGFILGRASTIM SUPPORT FOR FULL-DOSE THERAPY OF 6-EACODD-14 PROGRAM FOR ADVANCED STAGES HODGKIN'S LYMPHOMA PATIENTS. (EHA 2025) - "Single dose administration of pegfilgrastim has been demonstrated to be not inferior to filgrastim in terms of efficacy and could enable the delivery of the full dose of BEACOPP chemotherapy every 14 days...Chemotherapy of 6 cycles modified EACODD-14 program (etoposide, doxorubicin, cyclophosphamide, vincristine, dacarbazine, dexamethasone) in the "LH-Russia-1" protocol was performed in 43 patients with newly diagnosed high-risk cHL - stages IIB bulky, III/IV... The results of the study show the advantage of using of new prolonged form of G-CSF empegfilgrastim in the EACODD-14 program on the 4th or 5th day of the cycle to support full-dose regimen comparing the using filgrastim on the 9th-13th days of the same cycle. The lower incidence of infectious complications associated with deep neutropenia and the lower frequency of erythrocyte transfusions when using empegfilgrastim also indicate its advantage compared to filgrastim."

Clinical • Metastases • Classical Hodgkin Lymphoma • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Leukopenia • Lymphoma • Neutropenia • Oncology

Eflapegrastim, a Long-Acting Granulocyte Colony–Stimulating Factor, Administered the Same Day as Chemotherapy in Patients With Early-Stage Breast Cancer: Results From a Multicenter, Open-Label Study (MBCC 2025) - P1, P3 | "Eflapegrastim—a novel, long-acting, recombinant human GCSF linked to human IgG4 Fc fragment—showed improved bone marrow residence vs pegfilgrastim that may allow for same-day dosing. Conclusion Eflapegrastim given on the same day as docetaxel and cyclophosphamide chemotherapy may reduce the time to ANC recovery and related complications in early-stage breast cancer. The AEs observed were consistent with those observed with other GCSF products."

Back Pain • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Solid Tumor

STEM CELL MOBILIZATION WITH PEGFILGRASTIM IN PEDIATRIC PATIENTS FOR AUTOLOGOUS INFUSION: SAFE AND EFFECTIVE (EBMT 2025) - "PEGfilgrastim for stem cell mobilization was successful in all cases in our cohort. Nevertheless a substantial number of patients needed additional Filgrastim and/or Plerixafor. Therefore the protocol has been adjusted by increasing the dose of PEGfilgrastim (up to max."

Clinical • Bone Marrow Transplantation • Pediatrics • CD34

Cardioprotective Effect of Pegfilgrastim on Chemotherapy-induced Cardiotoxicity in Preoperative Chemotherapy for Breast Cancer. (PubMed, Anticancer Res) - "Pegfilgrastim may reduce chemotherapy-induced cardiotoxicity in addition to preventing febrile neutropenia."

Journal • Retrospective data • Breast Cancer • Cardiovascular • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor

Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma (clinicaltrials.gov) - P1/2 | N=4 | Terminated | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jul 2025 ➔ Jul 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jul 2025 ➔ Jul 2024; Administratively Complete 75%< Participants

Trial completion date • Trial primary completion date • Trial termination • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • IL3RA

A Combined Therapy of Pegylated G-CSF with Ciprofloxacin Mitigates Damage Induced by Lethal Ionizing Radiation to the Bone Marrow, Spleen, and Ileum by Increasing AKT Activation but Decreasing IL-18, C3, and miR-34a. (PubMed, Radiat Res) - "Ciprofloxacin (CIP) was found to enhance pegylated G-CSF therapy (PEG, Neulasta®)-induced survival from 30% to 85% after ionizing radiation exposure. The results taken together suggest that PEG+CIP combined treatment was effective in mitigating the radiation-induced bone marrow, spleen, and ileum injury. The mitigative effect of this combined treatment was mediated by increases in G-CSF levels that suppress miR-34a, thereby probably leading to decreased gasdermin D-mediated pyroptosis."

IO biomarker • Journal • Cerebral Hemorrhage • Gastrointestinal Disorder • Hematological Disorders • BAX • BCL2 • CLDN2 • CSF3 • IL18 • MIR34A