Dulastin (tripegfilgrastim) / Dong-A - LARVOL DELTA

Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: University of Washington

New P2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology

A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Children's Oncology Group | Active, not recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Embryonal Tumor • Germ Cell Tumors • Oncology • Solid Tumor • NF1

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) | Trial completion date: Dec 2027 ➔ Dec 2026 | Trial primary completion date: Dec 2027 ➔ Dec 2026

Trial completion date • Trial primary completion date • 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

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: Sep 2025 ➔ Dec 2025

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

A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: Children's Oncology Group | Recruiting ➔ Active, not recruiting

Enrollment closed • Brain Cancer • Embryonal Tumor • Germ Cell Tumors • Oncology • Solid Tumor • NF1

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=46 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jul 2025 ➔ Jul 2026 | Trial primary completion date: Jul 2025 ➔ Oct 2024

Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4

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

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

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

S0533: Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov) - P2 | N=29 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Feb 2025 ➔ Feb 2026

Trial completion date • Large Cell Carcinoma • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (clinicaltrials.gov) - P3 | N=244 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial primary completion date: Sep 2027 ➔ Dec 2027 | Trial completion date: Sep 2027 ➔ Dec 2027

Trial completion date • Trial primary completion date • 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

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

New P2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

Dulastin: Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers (clinicaltrials.gov) - P2 | N=98 | Recruiting | Sponsor: National Cancer Center, Korea | Not yet recruiting ➔ Recruiting

Enrollment open • Biliary Cancer • Cholangiocarcinoma • Febrile Neutropenia • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor

Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients (clinicaltrials.gov) - P3 | N=99 | Recruiting | Sponsor: The Affiliated People's Hospital of Ningbo University

New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology • CD34

Comparison of prophylactic effects for chemotherapy-induced neutropenia between same-day vs next-day administration of pegteograstim in chemotherapy regimen composed of day 1 intensive myelosuppressive agent: A randomized phase III trial (CONCISE, KCSG PC22-11). (ASCO 2024) - "Background: Administration of peg-GCSF 24 to 72 hours after chemotherapy is usually recommended...Patients with adjuvant/neoadjuvant or 1st palliative chemotherapy comprising intensively myleosuppressive agents on day 1 (mFOLFIRINOX, ECb, EP, FOLFIRI, and FOLFOX) are enrolled...This results in the need for a total of 160 patients, 80 in each arm. We are currently recruiting patients (since Nov 2022)."

Clinical • P3 data • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Neutropenia

Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (clinicaltrials.gov) - P3 | N=244 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2028 ➔ Sep 2027 | Trial primary completion date: Dec 2028 ➔ Sep 2027

Combination therapy • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

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=995 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2032 ➔ Apr 2025 | Trial primary completion date: Jun 2023 ➔ Mar 2024

Metastases • Trial completion date • Trial primary completion date • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Dulastin: Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers (clinicaltrials.gov) - P2 | N=98 | Not yet recruiting | Sponsor: National Cancer Center, Korea

New P2 trial • Biliary Cancer • Cholangiocarcinoma • Febrile Neutropenia • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor

Semimechanistic pharmacokinetic-pharmacodynamic model of tripegfilgrastim for pediatric patients after chemotherapy. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "Body weight affected the G-CSF receptor-mediated internalization of tripegfilgrastim, and the baseline ANC value impacted the production rate of G-CSF receptors. Simulations from the developed model suggested that 1.5, 2.5, 4, and 6 mg single subcutaneous tripegfilgrastim doses for the respective weight groups of 10-20, 21-30, 31-44, and more than 45 kg significantly reduced the duration of Grade 4 neutropenia similar to tripegfilgrastim weight-based treatment with 100 μg/kg."

Journal • PK/PD data • Chemotherapy-Induced Neutropenia • Hematological Disorders • Neutropenia • Oncology • Pediatrics • Solid Tumor • CSF3R

Comparison of prophylactic effects for chemotherapy induced neutropenia between same-day versus next-day administration of pegteograstim (Neurapeg®) in patients treated with chemotherapy regimen composed of day 1 intensive myleosuppressive agent: A randomized phase III clinical trial. (PubMed, Medicine (Baltimore)) - "Administration of pegylated granulocyte-colony-stimulating factor (peg-GCSF) 24 to 72 hours after chemotherapy is usually recommended...Patients with adjuvant/neoadjuvant or first-line palliative chemotherapy comprising intensively myelosuppressive agents on day 1 (mFOLFIRINOX, ECb, EP, FOLFIRI, and FOLFOX) are enrolled...In order to verify non-inferiority of 0.6 days, we estimated a significance level of 5%, power of 80%, and drop-out rate of 15%. This results in the need for a total of 160 patients, 80 in each group."

Journal • P3 data • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Neutropenia

A Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim (Dulastin®) after Single Administration in Pediatric Patients (ASH 2019) - P1; "Tripegfilgrastim (Dulastin®) is one of pegfilgrastim drugs, which was approved for adult CIN by Korea Ministry of Food and Drug Safety in 2014... Tripegfilgrastim have shown safety and tolerability in pediatric patients between 6 to 19 years old with solid tumors. The pharmacokinetics parameters, Cmax and AUC0-312h of HD group were increased by 45% compared with LD group, which translates into the better pharmacodynamics parameters of HD group without increasing toxicity. Our results suggests that Tripegfilgrastim 100 μg/kg once injection could be feasible to reduce CIN in pediatric patients."

Clinical • P1 data • PK/PD data

Exploratory biomarker analysis from neoadjuvant atezolizumab, pertuzumab, trastuzumab plus docetaxel (NEO-PATH) in HER2+ early breast cancer (ESMO-BC 2022) - P1/2 | "In patients with non-pCR, LRP1B (FDR=4.04e-04), ESR1 (FDR=1.07e-4) and RAD21 (FDR=2.05e-03) were highly expressed and ESR1, luminal and MYC related genesets showed higher expression (FDR<0.05).Conclusions Luminal subtype and MYC amplification were associated with non-pCR in patients with HER2-positive EBC who were treated with immunotherapy and anti-HER2 treatment combination. Further evaluation of the predictive role of these mutations are warranted."

Biomarker • Clinical • IO biomarker • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CDK12 • ER • HER-2 • LRP1B • MYC • RAD21

Predictive Parameters of Febrile Neutropenia and Clinical Significance of G-CSF Receptor Signaling Pathway in the Development of Neutropenia During R-CHOP Chemotherapy with Prophylactic Pegfilgrastim in Patients with Diffuse Large B-Cell Lymphoma. (PubMed, Cancer Res Treat) - "We investigated the predictive factors affecting CIN and FN incidence in patients with DLBCL receiving rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy with pegfilgrastim and conducted experiments to find reason for the occurrence of CIN even when pegfilgrastim was used...The rate of neutrophil apoptosis was also higher in neutrophils co-cultured with DLBCL cells and was further promoted by treatment with doxorubicin. Our findings suggest that high DLBCL burden may alter the BM environment and G-CSF receptor signaling pathway, even in chemotherapy-naïve state, which may increase CIN frequency during R-CHOP chemotherapy."

Clinical • Journal • Chemotherapy-Induced Neutropenia • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • CSF3 • CSF3R • CXCR4

Pegfilgrastim Prophylaxis is Effective in the Prevention of Febrile Neutropenia and Reduces Mortality in Patients Aged ≥75 Years with Diffuse Large B-Cell Lymphoma Treated with R-CHOP: A Prospective Cohort Study. (PubMed, Cancer Res Treat) - "Febrile neutropenia (FN) can cause suboptimal treatment and treatment-related mortality (TRM) in diffuse large B-cell lymphoma (DLBCL) patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP)...However, in patients aged ≥75 years, the 4-year OS and PFS rates were higher in this cohort than in the PROCESS cohort (OS: 49.6% vs. 33.7%, p=0.032; PFS: 44.2% vs. 30.3% p=0.047). Pegfilgrastim prophylaxis is effective in the prevention of FN and infection-related death in DLBCL patients receiving R-CHOP, and it also improves OS in patients aged ≥75 years."

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