Neupogen (filgrastim) / Kyowa Kirin, Amgen - LARVOL DELTA

First report of successful, lifesaving and timely graft rescue using an off-the-shelf cryopreserved, cadaveric marrow in myeloablative transplant with an unexpected unavailability of a living matched unrelated donor. (ASH 2025) - " A 34-year-old male with AML (NPM1, FLT3 TKD, KRAS, PTPN11, WT1, and RAD21 mutations) in first complete remission (CR1) began myeloablative fludarabine/busulfan conditioning in preparation for a 10/10 HLA-matched unrelated donor peripheral blood stem cell transplant...GVHD prophylaxis consisted of tacrolimus, mycophenolate mofetil, and post-transplant cyclophosphamide (PTCy, 50 mg/kg/d on Days +3 and +4). Patient received filgrastim post-transplant... This case report illustrates the feasibility and life-saving potential of using cryopreserved bone marrow from deceased donors in urgent allo-HCT scenarios. Day 0 was delayed by only 48 hours and the product was identified within 24 hours of request. Timely access to an off-the-shelf marrow product prevented catastrophic graft failure or debilitating opportunistic infections."

Acute Myelogenous Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Transplantation • CD33 • CD34 • FLT3 • KRAS • NPM1 • PTPN11 • RAD21 • WT1

Patients with multiple sclerosis above age 60 have neurological responses to autologous hematopoietic stem cell transplants similar to younger individuals: A single center experience (ASH 2025) - "Material and methods : We analyzed MS patients who prospectively received an aHSCT following the "Mexican method." The method, previously described and registered in ClinicalTrials.govNCT02674217, employs high-dose cyclophosphamide (200 mg/Kg), rituximab 1000 mg, dexamethasone, filgrastim, and MESNA. The overall PRR of persons with MS, given aHSCT with the "Mexican method," is 75.1%, and was similar among patients aged 60 years or less. The rate of early complications of the procedure was found to be similar. Accordingly, age above 60 years should not be considered as a reason to deny aHSCT to patients with MS."

Clinical • Bone Marrow Transplantation • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis • Transplantation

Dara-RVD in newly diagnosed multiple myeloma: Real-world clinical practice (ASH 2025) - "Depending on post-ASCT MRD status, patients received lenalidomide maintenance therapy, if MRD negativity was achieved...Antitumor treatment was administered alongside supportive therapy (sulfamethoxazole-trimethoprim, acyclovir), immunoglobulin infusions, osteomodifying agents...Seven patients underwent stem cell harvesting (etoposide 750 mg/m 2 )combined with short-acting filgrastim without routine plerixafor administration...Conclusion : In the context of limited access to CAR T-cell and bispecific therapies in Russia, early use of Dara-RVd with MRD-adaptive strategies shows high efficacy, including high-risk NDMM patients. This quadruplet-based approach may shift the treatment paradigm, though careful monitoring for complications like hypogammaglobulinemia is essential."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Musculoskeletal Pain • Pneumococcal Infections • Renal Disease • Respiratory Diseases • CD34 • CTCs

Adult acute myeloid leukaemia with DDX3X::MLLT10: A rare entity with significant unmet clinical needs (ASH 2025) - "She commenced salvage fludarabine, cytarabine, idarubicin and filgrastim (FLAG-Ida) therapy with BME on day 34 of treatment showing morphologic leukaemia-free state (MLFS)...She then commenced bridging venetoclax/azacitidine (Ven/Aza) therapy with a plan for allogeneic haematopoietic stem cell transplant...However, more data are required for further characterisation. These findings may inform future iterations of AML classification and prognostication (e.g., WHO) in adults."

Clinical • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Cerebral Hemorrhage • Hematological Malignancies • Infectious Disease • Leukemia • Respiratory Diseases • Septic Shock • T Acute Lymphoblastic Leukemia • CEBPA • DDX3X • FLT3 • JAK2 • KMT2A • KRAS • MLLT10 • NPM1 • SH2B3 • SMARCA4

Real-world experience in the first-line treatment of Acute Myeloid Leukemia with ven-aza: Optimizing venetoclax exposure for better outcomes (ASH 2025) - "Introduction: First-line treatment of acute myeloid leukemia (AML) with venetoclax and azacytidine (VenAza) is both effective and safe, including in the elderly population...Patients treated with Ven-decitabine or with triplet combinations were excluded...Filgrastim was used solely on demand, exclusively in pts with a documented CR, and was used in support of one-fifth (19.4%) of cycles in CR that were delayed, and on-cycle in 7.4% of cycles in CR. Our series, including both elderly or unfit pts, and younger chemotherapy-eligible pts, was able to reach a median OS of almost two years, with a median of 4.9-week cycles with 28 days of Ven, with on-demand G-CSF support, showing how an effort to maximize Ven exposure can lead to optimal outcomes."

Clinical • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Febrile Neutropenia • Neutropenia

Clinical implications and prevalence of benign ethnic neutropenia (BEN) in lymphoma patients of middle eastern ethnicity (ASH 2025) - "In the HL group, none of the variables assessed like age, stage, BEN status, clinical parameters or chemotherapy regimen received correlated with EFS in univariate analysis.In the DLBCL grp, receipt of R-CEOP regimen (compared to R-CHOP) and high IPI scores were significantly associated with inferior OS and EFS while BEN was not significantly associated with OS (HR = 0.44; 95% CI: 0.058–3.36; p = 0.430) or EFS (HR = 0.56; 95% CI: 0.13–2.37; p = 0.427)...Treatment delays due to the apparent neutropenia are common, however, response to filgrastim is universal, and febrile neutropenia episodes are rarely seen...Since these patients are not at increased risk of infection larger studies can potentially identify unique neutrophil count thresholds for holding chemotherapy in these patients to avoid compromising therapy. This can have important implications for the management of oncology patients of these ethnicities."

Clinical • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Leukopenia • Lymphoma • Neutropenia

Safety and feasibility of outpatient myeloablative total marrow and lymphoid Irradiation–based allogeneic transplantation in adults with high-risk acute lymphoblastic leukemia (ASH 2025) - "The conditioning regimen wascyclophosphamide (Cy) 350 mg/m² and fludarabine25 mg/m² (day -6 to -4) followed by TMLI; 12 Gy in 6fractions of 2 Gy every 12 hours (day -3 to -1) delivered using a tomotherapy system...Graft-versus-host disease (GVHD) prophylaxisconsisted in tacrolimus or cyclosporin A started on day 0 followed by Cy 30 mg/kg for matched relatedand 40 mg/kg for haploidentical HSCT on day +3 and +4, and mycophenolate mofetil starting on day +5-30. Filgrastim (300 mcg/day) was started on day +5 until stable engraftment...Themedian prior therapy lines were 3 (range, 2-4), 50% blinatumomab-exposed...One-yearOS, RFS, CIR and NRM rates were 81.3%, 80%, 24% and 7.1% respectively. Conclusion TMLI-based conditioning in adolescents and young adults with ALL was feasible and safe, allowing for afull-outpatient conduct in 57% of patients, supporting further studies assessing its efficacy and the safetyof larger doses."

Clinical • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Anorexia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Cytomegalovirus Infection • Gastroenterology • Gastroesophageal Reflux Disease • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Mucositis • Neutropenia • Stomatitis • Transplantation

Clinical implications and prevalence of benign ethnic neutropenia (BEN) in lymphoma patients of middle eastern ethnicity (ASH 2025) - "In the DLBCL group, receipt of R-CEOP regimen (compared to R-CHOP) and high IPI scores were significantly associated with inferior OSand EFS, while BEN status had no impact on survival...Treatment delays due to theapparent neutropenia are common, however response to filgrastim is universal, and febrile neutropeniaepisodes are rarely seen. There was no adverse impact of BEN on the survival of lymphoma patients onchemotherapy.This study is of particular relevance in populations with a high prevalence of ethnic neutropenia. SinceBEN patients are not at increased risk of infection, larger studies can potentially identify uniqueneutrophil count thresholds for holding chemotherapy in these patients to avoid compromising therapy.This can have far-reaching implications for the management of oncology patients of these ethnicities."

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma

FLAG/VEN as a frontline induction therapy for AML: A multi-centre experience of Anthracycline free approach from India (ASH 2025) - "RGCIRC/IRB-BHR/04/2023 dated 4th February 2023.Induction therapy: All patients received tumor lysis syndrome prophylaxis with intravenous hydrationand Tab Febuxostat...Fludarabine 30 mg/m2 IV once daily for 4 days, Cytarabine 1500 mg/m2 IV oncedaily for 4 days...Filgrastim (biosimilar) 5 mcg/kg s/c once daily from day −1 to ANC > 500 cells/ µL...Venetoclax was given as 50 mg for day 1 and2 followed by 100 mg once daily...CBF AML patientsin CR1 at day 28 in both arms received FLAG with Gemtuzumab Ozogamicin (GO) based consolidationtherapy for 4 cycles... Our results suggests that FLAG/VEN approach can decrease induction mortality rate whichis anywhere about 20-25 % in a lower middle-income country like India. FLAG/VEN achieves high CR ratesof 93% which is comparable to FLAG/IDA/VEN approach without added toxicity in the real-world scenario.This approach needs to be tested in a randomized controlled trial to establish it as a standard therapy forAML."

Clinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Febrile Neutropenia • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Pneumonia • Respiratory Diseases • Septic Shock • Tuberculosis • TP53

Complete donor chimerism following deceased-donor liver transplant in an adolescent with hepatitis-associated severe aplastic anemia (ASH 2025) - "Filgrastim was initiated on POD19, with her absoluteneutrophil count (ANC) rising from 60/µL to > 2,000/µL within 5 d, and discontinued on POD40...Romiplostim was held for periods of 2–4 mo (e.g., 20–24 mo pLT); however, theplt cts progressively dropped to the 140,000s and responded to intermittent low-dose administration (3mcg/kg)...Although this may reflectthe incidence of HA-SAA in children versus adults, other age-related factors may contribute, e.g., numberof donor-derived HSCs transferred and size of the recipient. Additional factors may include conditionswith extramedullary hematopoiesis or increased circulating CD34+ cells at time of liver donation."

Anemia • Aplastic Anemia • Dermatitis • Dermatology • Graft versus Host Disease • Hepatology • Immunology • Inflammation • Liver Failure • Thrombocytopenia • Transplantation • CD34

Selinexor, mezigdomide, and dexamethasone in patients with Relapsed/Refractory multiple myeloma who relapsed or are ineligible for T-cell–redirecting therapy: Stomp Phase 1 results (ASH 2025) - P1/2 | "Both selinexor (S), an oral exportin 1 (XPO1)inhibitor (approved in combination with dexamethasone (d) in penta-refractory MM and with dand bortezomib in RRMM after ≥1 prior therapy), and mezigdomide (M), a novel and potentcereblon E3 ubiquitin ligase modulator (under investigation in RRMM), have shown T-cellpreservation/stimulatory activity...Three pts (23.1%) had relapsed after TCRT (3cilta-cel; 2 talquetamab; 1 IGM-2644), and 4 after belantamab mafodotin, with 30.8% beingrefractory to B-cell maturation antigen–targeted therapy.As of July 8, 2025, no dose-limiting toxicities (DLTs) were encountered in cohorts 1 and 2... For the all-oral combination of SMd, TEAEs were consistent with AE profiles for S andM, and no new safety signals were detected; DLT of G4 neutropenia was reported butmanageable with filgrastim support and dose reduction. Across all dose levels, SMd showedefficacy in pts with heavily pre-treated RRMM in whom TCRT had failed or who otherwise..."

Clinical • IO biomarker • P1 data • Cardiovascular • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Leukopenia • Multiple Myeloma • Neutropenia • Targeted Protein Degradation • Thrombocytopenia • CCR7 • CRBN • TIGIT • XPO1

Clinical study on the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor injection (PEG-rhG-CSF) in autologous hematopoietic stem cell mobilization for lymphoma - Results of interim analysis (ASH 2025) - P2 | "In the control group, when the platelets and white blood cells began to rise after reaching thelowest point after chemotherapy, rhG-CSF (Filgrastim) at a dose of 10 μg/kg/d was given...In this study, patients with bone marrow involvement and massive splenomegalywere excluded, and the use of plerixafor for rescue was not allowed. 1... For lymphoma patients undergoing chemotherapy combined with PEG-rhG-CSF formobilizing peripheral blood stem cells, compared with the combination of rhG-CSF, the mobilizationsuccess rate is the same, while the peak of CD34+ is reached earlier, and the number of collections toreach the standard is significantly reduced, with 52.4% of patients only needing 1 collection. Among theadverse reactions, the degree and proportion of thrombocytopenia during the PEG-rhG-CSF process aremore severe, which requires clinical attention."

Hematological Disorders • Hematological Malignancies • Lymphoma • Thrombocytopenia • CD34

Interim analysis of efficacy and safety for ALLG MM25 (Viber-M): A phase I b/II study of venetoclax, iberdomide and dexamethasone for patients in first or second relapse of multiple myeloma with t(11; 14) (ASH 2025) - "Given the high attrition rates in patient numbers at each relapse,prioritising effective treatments early in the disease course is vital.In the era of lenalidomide (Len)-based induction and maintenance, there is need for a Len-free regimenat relapse. Iberdomide (Iber) is a potent oral cereblon E3 ligase modulator (CELMoD)...G3/4 TEAEs were reported in 11 patients (55%), with neutropenia being the most common(45%); 12 patients (60%) required filgrastim support...As of data cutoff, 44 of 50 patients have been enrolled. The planned interim analysis was conducted forthe first 20 patients (median age 65 years; range 41-83) following completion of three treatment cycles.Of these, 12 (60%) underwent planned dose escalation over three cycles, and 8 (40%) over two cycles. Themajority (75%) had one prior LOT."

Clinical • Febrile Neutropenia • Hematological Malignancies • Infectious Disease • Lymphoma • Multiple Myeloma • Neutropenia • Targeted Protein Degradation • Thrombocytopenia • CRBN

Preventive stRategy for IMMU132-relatED AEs in TNBC or Luminal Breast Cancer- PRIMED (clinicaltrials.gov) - P2 | N=50 | Completed | Sponsor: MedSIR | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

Clinical and Economic Impact of Preemptive UGT1A1*28 Genotyping in Metastatic Breast Cancer Patients Treated with Sacituzumab Govitecan: Real-World Experience (SABCS 2025) - "Both UGT1A11/28 patients required dose adjustments: one with a 25% reduction and filgrastim prophylaxis, and another with a 75% dose. This real-world series suggests that the UGT1A1*28 genotype is associated with a higher risk of severe toxicity, hospitalization, and dose modification in SG-treated patients. Although one UGT1A1*1/*1 patient also experienced severe toxicity, most serious events occurred in UGT1A1*28 carriers. Given the low cost of genotyping, implementing preemptive UGT1A1*28 testing prior to SG initiation may be a cost-effective strategy to anticipate and reduce serious adverse events."

Clinical • HEOR • Metastases • Real-world • Real-world evidence • Breast Cancer • Oncology • Solid Tumor • UGT1A1

Auto BMT for Non-M3 AML in 1st Remission in Pts </=60y of Age Using Busulfan/FTBI & VP16 as a Prep R (clinicaltrials.gov) - P2 | N=60 | Completed | Sponsor: City of Hope Medical Center | Active, not recruiting ➔ Completed

Trial completion • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Essential Thrombocythemia • Hematological Malignancies • Leukemia • Oncology • Transplantation

CD45RA-depleted CD19-CAR T Cell Consolidation After TCR??+ T Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: St. Jude Children's Research Hospital

New P1 trial • Hematological Malignancies • Lymphoma • Oncology • Pediatrics • Transplantation

HSCT: Mozobil for Autologous Hematopoietic Stem Cell Transplantation (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Thomas Jefferson University | Not yet recruiting ➔ Recruiting

Enrollment open • Bone Marrow Transplantation • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Cyp7b1-inhibiting azoles as novel enhancers of hematopoietic stem and progenitor cell mobilization. (PubMed, bioRxiv) - "While granulocyte colony-stimulating factor (G-CSF, filgrastim) remains the standard mobilization agent, many patients respond inadequately, and it can trigger life-threatening vaso-occlusive crises in SCD. Importantly, intravenous administration of voriconazole, a clinically approved systemic antifungal with Cyp7b1-binding activity, similarly augmented AMD3100-induced HSPC mobilization in wild-type and SCD mice without altering steady-state hematopoiesis. These findings establish Cyp7b1-inhibiting azoles as novel and clinically relevant enhancers of HSPC mobilization, particularly for SCD patients who cannot safely receive G-CSF but require robust HSPC yields for gene therapy."

Journal • Gene Therapies • Genetic Disorders • Hematological Disorders • Sickle Cell Disease • Transplantation

hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM) (clinicaltrials.gov) - P2 | N=16 | Recruiting | Sponsor: Leland Metheny | Suspended ➔ Recruiting

Enrollment open • Brain Cancer • Glioblastoma • Gliosarcoma • Oncology • Sarcoma • Solid Tumor • IDH1

Prolonged myopathy and musculoskeletal symptoms following filgrastim in a 43-Year-Old female stem cell donor: a case-based review. (PubMed, Rheumatol Int) - "A single dose of intramuscular betamethasone led to gradual recovery of muscular function. This case underscores the importance of recognizing potential long-term iatrogenic effects of G-CSF, even in healthy donors, and highlights the need for individualized follow-up and management."

Journal • Review • Musculoskeletal Diseases • Musculoskeletal Pain • Myositis • Orthopedics • Pain

Successful engraftment in myeloablative transplant with cadaveric marrow after sudden unavailability of living donor. (PubMed, Blood Adv) - "After sudden unavailability of a living unrelated donor due to adverse event related to neupogen, in a patient who had initiated myeloablative conditioning, we successfully engrafted a deceased donor marrow product infused within 72 hours of request."

Journal • Transplantation

Granulocyte colony-stimulating factor for recurrent implantation failure: the results of a 5-years cohort study. (PubMed, Sci Rep) - P | "Endometrial thickness increased by 1.15 ± 1.5 cm in the study group; data for this variable in the control group were poorly documented. IU G-CSF administration in idiopathic RIF patients before undergoing fresh ET improved implantation rates, while it did not alter clinical or chemical pregnancy or first-trimester abortion rates.Trial registration: This study was registered with the identifier NCT04998279 on 26/7/2021 in the National Library of Medicine registry (clinicaltrials.gov)."

Journal • Gynecology • Infertility • Obstetrics • Sexual Disorders

Persistent BCR::ABL1 p190 Minimal Residual Disease and Declining Donor Chimerism Following Haploidentical Bone Marrow Transplant in Pediatric Acute Myeloid Leukemia With Dual High-Risk Fusions. (PubMed, Cureus) - "Post-transplant recovery was marked by poor initial engraftment, requiring platelet transfusions and biweekly filgrastim...Despite hematologic recovery, qPCR consistently revealed persistent BCR::ABL1 p190 expression, indicating residual disease. This case underscores the challenge of eradicating leukemic stem cells (LSCs) in high-risk AML and supports the integration of next-generation flow cytometry for enhanced MRD and LSC assessment post-transplant."

Journal • Minimal residual disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Cardiovascular • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Pediatrics • Septic Shock • Transplantation • ABL1 • CD34 • MECOM • RUNX1

Less May be More: The Impact of Post-Remission Intensive (IC) Consolidation Cycles on Outcomes in Newly Diagnosed Acute Myeloid Leukemia Receiving IC + Venetoclax (ASH 2024) - "The addition of venetoclax (VEN) to IC regimens such as cladribine, idarubicin, and cytarabine (CLIA) and fludarabine, cytarabine, idarubicin, and filgrastim (FLAG-IDA) has shown excellent outcomes in clinical trials. MVA identified the use of maintenance therapy, but not number of IC consolidation cycles, as a predictor of improved OS and RFS. Prospective trials are needed to confirm whether fewer cycles IC + VEN coupled with lower intensity maintenance can yield comparable outcomes to multiple consolidations while mitigating toxicity for pts not receiving SCT."

Clinical • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Leukemia • Neutropenia • Oncology