^
    6d
    Mecapegfilgrastim Combined With Adebrelimab and Chemotherapy as Neoadjuvant Therapy in Resectable GC/GEJC (clinicaltrials.gov)
    P2, N=70, Not yet recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial
    |
    docetaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • Ariely (adebrelimab) • Pegylated rhG-CSF (mecapegfilgrastim)
    10d
    RP2-202: A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma (clinicaltrials.gov)
    P2/3, N=280, Recruiting, Replimune Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Checkpoint inhibition • Metastases
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • RP2
    2ms
    Dulastin: Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers (clinicaltrials.gov)
    P2, N=98, Recruiting, National Cancer Center, Korea | Not yet recruiting --> Recruiting
    Enrollment open
    |
    ondansetron
    2ms
    Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced Unresectable or Metastatic HCC (clinicaltrials.gov)
    P2, N=30, Recruiting, Replimune Inc. | Not yet recruiting --> Recruiting | N=60 --> 30 | Trial completion date: Jul 2027 --> Jul 2028 | Trial primary completion date: Apr 2027 --> Dec 2027
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Oncolytic virus • Metastases
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2
    2ms
    Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer (clinicaltrials.gov)
    P1, N=59, Completed, Spectrum Pharmaceuticals, Inc | Active, not recruiting --> Completed
    Trial completion
    |
    docetaxel • cyclophosphamide • Rolvedon (eflapegrastim-xnst)
    2ms
    Continuous Versus Bolus Administration of G-CSF in Children With Cancer (clinicaltrials.gov)
    P4, N=20, Active, not recruiting, Chang Gung Memorial Hospital | Recruiting --> Active, not recruiting | N=40 --> 20
    Enrollment closed • Enrollment change
    |
    Granocyte (lenograstim) • Neupogen (filgrastim)
    2ms
    Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov)
    P2, N=270, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    cytarabine • decitabine • Mylotarg (gemtuzumab ozogamicin) • idarubicin hydrochloride • fludarabine IV • Neupogen (filgrastim) • Starasid (cytarabine ocfosfate)
    2ms
    Study on the Efficacy and Safety of Pegfilgrastim in Primary Prevention of Chemotherapy-induced Neutropenia in Non-Hodgkin Lymphoma (ChiCTR2400087519)
    P=N/A, N=50, Not yet recruiting, Anqing Municipal Hospital; Anqing Municipal Hospital
    New trial
    |
    Neulasta (pegfilgrastim)
    2ms
    SMART: Non-interventional, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Stem Cell Donors (clinicaltrials.gov)
    P=N/A, N=245, Completed, Sandoz | Active, not recruiting --> Completed
    Trial completion
    3ms
    RP2-202: A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma (clinicaltrials.gov)
    P2/3, N=280, Not yet recruiting, Replimune Inc.
    New P2/3 trial • Combination therapy • Checkpoint inhibition • Metastases
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • RP2
    3ms
    BREASTIMMU02: Impact of Pegfilgrastim on Trastuzumab Anti-tumor Effect and ADCC in Operable HER2+ Breast Cancer Breast Cancer (clinicaltrials.gov)
    P2, N=90, Recruiting, Centre Leon Berard | Trial completion date: Apr 2024 --> Sep 2025 | Trial primary completion date: Apr 2024 --> Jan 2025
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    Herceptin (trastuzumab) • paclitaxel • Neulasta (pegfilgrastim)
    3ms
    Results of a phase I/IIa trial of SV-BR-1-GM inoculation with low-dose cyclophosphamide and interferon alpha (Bria-IMT) in metastatic breast cancer. (PubMed, Hum Vaccin Immunother)
    Eight of 10 patients significantly upregulated programmed cell death ligand 1 (PD-L1) on CTCs/CAMLs with treatment (p = .0012). These observations support the safety of the Bria-IMT regimen, demonstrate clinical regressions, imply a role for HLA matching, and identify a possible value for monitoring CAMLs in peripheral blood.
    P1/2 data • Journal • Metastases
    |
    CSF2 (Colony stimulating factor 2)
    |
    cyclophosphamide • Bria-IMT (SV-BR-1-GM)
    4ms
    Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients (clinicaltrials.gov)
    P3, N=99, Recruiting, The Affiliated People's Hospital of Ningbo University
    New P3 trial
    |
    CD34 (CD34 molecule)
    |
    cytarabine • cyclophosphamide • etoposide IV • Neulasta (pegfilgrastim)
    4ms
    Etoposide + cytarabine + pegfilgrastim versus cyclophosphamide + G-CSF for stem cell mobilization in patients with poorly mobilized multiple myeloma and lymphoma (ChiCTR2400086421)
    P=N/A, N=87, Recruiting, The Affiliated People's Hospital of Ningbo University; The Affiliated People's Hospital of Ningbo University
    New trial
    |
    CD34 (CD34 molecule)
    |
    cytarabine • cyclophosphamide • etoposide IV • Neulasta (pegfilgrastim)
    5ms
    A case of triple negative breast cancer with cold agglutinin disease and difficulty in perioperative drug therapy (JBCS 2024)
    After that, because it was difficult to obtain intravenous drip infusion, a CV port was placed in the right subclavian vein, and docetaxel therapy was initiated...In the fourth course, perhaps because G-Lasta was administered, no FN was observed, but anemia with Hb of 5.0 was observed and a blood transfusion was required...In this case, the patient had triple-negative breast cancer with cold agglutinin disease, but during postoperative chemotherapy, she developed FN and severe anemia, making treatment difficult. It seems important to educate patients about infection control and to visit a hospital when they experience symptoms of anemia
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    BRACAnalysis CDx™
    |
    docetaxel • Neulasta (pegfilgrastim)
    6ms
    Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer (clinicaltrials.gov)
    P1, N=50, Active, not recruiting, Spectrum Pharmaceuticals, Inc | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    docetaxel • cyclophosphamide • Rolvedon (eflapegrastim-xnst)
    6ms
    RATHL: Fludeoxyglucose F 18-PET/CT Imaging in Assessing Response to Chemotherapy in Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Hodgkin Lymphoma (clinicaltrials.gov)
    P3, N=1202, Completed, University College, London | Active, not recruiting --> Completed | Trial completion date: May 2023 --> May 2024
    Trial completion • Trial completion date • FDG PET • Metastases
    |
    doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • dacarbazine • Matulane (procarbazine hydrochloride) • bleomycin • vinblastine • Neulasta (pegfilgrastim) • Neupogen (filgrastim) • prednisolone
    7ms
    Prophylactic Administration of Neulapeg (Pegteograstim) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Receiving the Modified FOLFIRINOX (clinicaltrials.gov)
    P2, N=78, Active, not recruiting, Yonsei University
    New P2 trial • Metastases
    |
    5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium
    8ms
    RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC (clinicaltrials.gov)
    P2, N=4, Active, not recruiting, Replimune Inc. | N=60 --> 4
    Enrollment change • Combination therapy • Oncolytic virus • Mismatch repair • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3
    8ms
    Timing of Administration of Pegfilgrastim and Prophylaxis for Febrile Neutropenia for Patients with Early Breast Cancer Receiving Chemotherapy (PubMed, Gan To Kagaku Ryoho)
    Regarding neoadjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer, taxanes and trastuzumab with the addition of pertuzumab have shown higher pathological complete response rates and elevated incidences of FN...The RDI of all regimens was 99.7%. Although there were some differences in chemotherapy regimens, an earlier timing of PEG prophylaxis(especially 24-48 hours from chemotherapy completion)has been shown to reduce the incidence of FN and increase the RDI.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR positive
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Neulasta (pegfilgrastim)
    9ms
    BRIA-ABC: Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. (clinicaltrials.gov)
    P3, N=404, Recruiting, BriaCell Therapeutics Corporation | Initiation date: Oct 2023 --> Feb 2024
    Trial initiation date • Metastases
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    carboplatin • capecitabine • cyclophosphamide • Halaven (eribulin mesylate) • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    9ms
    A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy (clinicaltrials.gov)
    P2, N=40, Recruiting, Spectrum Pharmaceuticals, Inc | Trial completion date: Oct 2025 --> Oct 2027 | Trial primary completion date: Jul 2025 --> Oct 2027
    Trial completion date • Trial primary completion date
    |
    docetaxel • doxorubicin hydrochloride • cyclophosphamide • Rolvedon (eflapegrastim-xnst)
    9ms
    Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer (clinicaltrials.gov)
    P1, N=50, Recruiting, Spectrum Pharmaceuticals, Inc | N=90 --> 50 | Trial completion date: Jun 2025 --> Jul 2024 | Trial primary completion date: Dec 2024 --> Jul 2024
    Enrollment change • Trial completion date • Trial primary completion date
    |
    docetaxel • cyclophosphamide • Rolvedon (eflapegrastim-xnst)
    9ms
    Etoposide combined with cytarabine and pegfilgrastim for poorly mobilizing patients with multiple myeloma and lymphoma: A prospective multicentre study. (PubMed, Br J Haematol)
    The duration of neutrophil and platelet engraftment was 11 days. In conclusion, these results suggest that the EAP mobilization regimen might be a promising option for poorly mobilizing patients with MM or lymphoma.
    Journal
    |
    CD34 (CD34 molecule)
    |
    cytarabine • etoposide IV • Neulasta (pegfilgrastim)
    9ms
    NEUTHREE: Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy (clinicaltrials.gov)
    P4, N=100, Recruiting, Eunseong Medical Foundation Good GANG-AN HOSPITAL | Not yet recruiting --> Recruiting | Trial completion date: Jan 2025 --> Jul 2025 | Initiation date: Aug 2023 --> Nov 2023 | Trial primary completion date: Jul 2024 --> Jan 2025
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    Neulasta (pegfilgrastim) • Rolvedon (eflapegrastim-xnst)
    9ms
    A Trial of HHPG-19K Injection and Auto-HHPG-19K Injection in Prevention of Chemotherapy-related Moderate to Severe Neutropenia of Patients With Nonmyeloid Malignancies (clinicaltrials.gov)
    P3, N=107, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
    New P3 trial
    |
    Pegylated rhG-CSF (mecapegfilgrastim)
    11ms
    Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov)
    P2, N=270, Recruiting, M.D. Anderson Cancer Center | N=200 --> 270
    Enrollment change
    |
    cytarabine • decitabine • Mylotarg (gemtuzumab ozogamicin) • idarubicin hydrochloride • fludarabine IV • Neupogen (filgrastim) • Starasid (cytarabine ocfosfate)
    11ms
    RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Replimune Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Oncolytic virus • Mismatch repair • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3
    12ms
    Mecapegfilgrastim for peripheral blood stem cell mobilization in patients with lymphoproliferative diseases (ChiCTR2300074548)
    P=N/A, N=40, Recruiting, Mianyang Central Hospital; Mianyang Central Hospital
    New trial
    |
    CD34 (CD34 molecule)
    12ms
    Continuous Versus Bolus Administration of G-CSF in Children With Cancer (clinicaltrials.gov)
    P4, N=40, Recruiting, Chang Gung Memorial Hospital
    New P4 trial
    |
    Granocyte (lenograstim) • Neupogen (filgrastim)
    almost1year
    Dulastin: Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers (clinicaltrials.gov)
    P2, N=98, Not yet recruiting, National Cancer Center, Korea
    New P2 trial
    |
    ondansetron
    1year
    EFFICACY AND SAFETY OF BIOSIMILAR PEGFILGRASTIM AFTER AUTOLOGOUS STEM CELL TRANSPLANT: A COMPARATIVE STUDY WITH BIOSIMILAR FILGRASTIM, LENOGRASTIM AND ORIGINATOR PEGFILGRASTIM (SIE 2023)
    Similar results were obtained performing two separate sub-analysis only for lymphoma or myeloma patients. From our data biosimilar Pegfilgrastim seems to be substantially equivalent in terms of efficacy to the originator one and superior than Lenograstim and biosimilar Filgrastim in terms of hematologic recovery, when used in this setting.
    Clinical
    |
    CD34 (CD34 molecule)
    |
    Neulasta (pegfilgrastim)
    1year
    Loss of CD34 Cells and Effect of the Number of Viable Cryopreserved CD34 Cells in the Infused Blood Grafts on Hematologic Recovery, Progression-Free Survival and Overall Survival in NHL Patients After Autologous Stem Cell Transplantation. (PubMed, Clin Lymphoma Myeloma Leuk)
    G-CSF type used in mobilization and mobilization capacity were found to correlate with viable CD34 cell loss during processing and storage. Most importantly, low infused viable CD34 cell count did not seem to impact on PFS or OS.
    Journal
    |
    CD34 (CD34 molecule)
    |
    Neulasta (pegfilgrastim) • Lonquex (lipegfilgrastim biosimilar)
    1year
    Lapelga vs Gastrofil (clinicaltrials.gov)
    P3, N=74, Not yet recruiting, Lawson Health Research Institute
    New P3 trial
    |
    CD34 (CD34 molecule)
    1year
    CARDIOSTEM: Donation of Whole Blood by Healthy Volunteers After Mobilisation by Haematopoietic Growth Factor (Rhu-G-CSF = Granocyte) (clinicaltrials.gov)
    P1, N=40, Recruiting, CellProthera | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    Granocyte (lenograstim)
    1year
    BRIA-ABC: Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. (clinicaltrials.gov)
    P3, N=404, Recruiting, BriaCell Therapeutics Corporation | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    carboplatin • capecitabine • cyclophosphamide • Halaven (eribulin mesylate) • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    1year
    NEO-IMPACT: NEO-adjuvant Chemo-immunotherapy in Pancreatic Cancer (clinicaltrials.gov)
    P2, N=20, Recruiting, Australasian Gastro-Intestinal Trials Group
    New P2 trial
    |
    Imfinzi (durvalumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Neulasta (pegfilgrastim)
    1year
    Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov)
    P2, N=200, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    cytarabine • decitabine • Mylotarg (gemtuzumab ozogamicin) • idarubicin hydrochloride • fludarabine IV • Neupogen (filgrastim) • Starasid (cytarabine ocfosfate)
    1year
    BIOMARKER-BASED IDENTIFICATION OF HIGH-RISK GROUPS FOR PRIMARY HEPATOCELLULAR CARCINOMA IN CHRONIC HEPATITIS B PATIENTS UNDER THE NUCLEOS(T)IDE ANALOGUE TREATMENT (AASLD 2023)
    Stored sera were used to measure GDF15 using ELISA and HBcrAg using immunoassay for total antigen including complex by pretreatment (iTACT) technology... Male sex, high γ-GTP, high AFP, high GDF15 and fibrosis progression were high risk factors for the occurrence of primary HCC in CHB patients under NUC treatment.
    Clinical
    |
    GDF15 (Growth differentiation factor 15)
    |
    GDF15-L
    1year
    BRIA-ABC: Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. (clinicaltrials.gov)
    P3, N=404, Not yet recruiting, BriaCell Therapeutics Corporation
    New P3 trial • Metastases
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    carboplatin • capecitabine • cyclophosphamide • Halaven (eribulin mesylate) • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    1year
    Combination Study of SV-BR-1-GM With Retifanlimab (clinicaltrials.gov)
    P1/2, N=36, Enrolling by invitation, BriaCell Therapeutics Corporation | Recruiting --> Enrolling by invitation
    Enrollment status • Combination therapy • Metastases
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 negative • PGR positive • PGR negative
    |
    cyclophosphamide • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)