Neulasta (pegfilgrastim)

P1, N=14, Terminated, Monopar Therapeutics | N=21 --> 14 | Trial completion date: Jun 2025 --> May 2024 | Recruiting --> Terminated | Trial primary completion date: Jun 2025 --> Oct 2023; lack of timely enrollment

P3, N=1202, Completed, University College, London | Active, not recruiting --> Completed | Trial completion date: May 2023 --> May 2024

P3, N=995, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2032 --> Apr 2025 | Trial primary completion date: Jun 2023 --> Mar 2024

P2/3, N=600, Recruiting, Sutro Biopharma, Inc. | Phase classification: P2 --> P2/3 | N=140 --> 600

P1, N=21, Active, not recruiting, St. Jude Children's Research Hospital

P2, N=29, Active, not recruiting, National Cancer Institute (NCI)

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.

P=N/A, N=100, Recruiting, Centre Georges Francois Leclerc | Trial completion date: Apr 2024 --> Oct 2025 | Trial primary completion date: Apr 2024 --> Sep 2025

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.

P1, N=21, Recruiting, Monopar Therapeutics | Phase classification: P1b --> P1 | Trial primary completion date: Jun 2023 --> Jun 2025

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

P1, N=65, Active, not recruiting, New Approaches to Neuroblastoma Therapy Consortium | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

P2, N=48, Active, not recruiting, Washington University School of Medicine | Trial completion date: Dec 2023 --> Jun 2024

P2, N=21, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025

P2, N=26, Recruiting, University of Wisconsin, Madison

P3, N=995, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2032

P3, N=995, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Jun 2023

P1/2, N=116, Recruiting, M.D. Anderson Cancer Center | Phase classification: P1b/2 --> P1/2

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.

P1, N=54, Recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2023 --> Jun 2025 | Trial primary completion date: Sep 2023 --> Jun 2025

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.

P2, N=17, Recruiting, University of Washington | Trial primary completion date: Oct 2023 --> Apr 2024

P1, N=18, Completed, Washington University School of Medicine | Active, not recruiting --> Completed

P2, N=21, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=60 --> 21

Part 1 is the dose-optimization stage, with ~50 subjects randomized 1:1 at 4.3 mg/kg Q3W or 5.2 mg/kg Q3W + prophylactic pegfilgrastim for 2 cycles followed by 4.3 mg/kg Q3W. Key exclusion criteria: primary platinum refractory disease and prior treatment with a FolRα ADC or ADC-containing tubulin inhibitor. Current Trial Status: Currently enrolling

P2, N=20, Recruiting, Australasian Gastro-Intestinal Trials Group

P=N/A, N=100, Recruiting, Centre Georges Francois Leclerc | Not yet recruiting --> Recruiting | Trial completion date: Apr 2023 --> Apr 2024 | Trial primary completion date: Apr 2023 --> Apr 2024

P1, N=46, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Sep 2024

In this secondary analysis of a phase III randomized trial of chemotherapy alone for DLBCL, initial bulk was not shown to be significantly associated with outcomes. Prospective data comparing consolidative RT versus no RT are necessary to determine optimal treatment paradigms.

Biosimilar filgrastim and pegfilgrastim as primary prophylaxis are cost-effective approaches to avoid FN events in patients with BC, NSCLC, or NHL at intermediate risk for FN in Austria, France, and Germany.

P2, N=26, Recruiting, University of Wisconsin, Madison | N=46 --> 26 | Trial completion date: Oct 2025 --> May 2026 | Trial primary completion date: Apr 2024 --> Dec 2024

Introduction: High dose melphalan with autologous hematopoietic stem cell transplantation (AHCT) for multiple myeloma is effective for disease control, but has a period of obligate neutropenia. The addition of plinabulin to pegfilgrastim did not add major toxicities after AHCT. Patients had elevated WBC on Day +2, low rates of NENF, and potentially less need for transfusion support. Plinabulin PK, quality of life data, and PROs will be presented.

P1/2, N=138, Active, not recruiting, Mayo Clinic | Trial completion date: Jul 2024 --> Nov 2024

Neoadjuvant dose-dense biweekly nanoparticle albumin-bound paclitaxel followed by dose-dense epirubicin and cyclophosphamide was effective, especially in patients with triple-negative disease, and feasible with pegfilgrastim support.

We aimed to investigate the effects of PP on FN-related hospitalization and death in patients with DLBCL receiving rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)...Among patients receiving their first R-CHOP cycle during 2014-2016, the HR for FN-related hospitalization was 0.90 (P = 0.014) in PP users compared with non-users. PP with a long-acting G-CSF lowered the FN-related hospitalization risk but did not benefit survival in patients with DLBCL receiving R-CHOP.

Objective: The combination of gemcitabine and docetaxel is commonly used in patients with recurrent bone or soft tissue sarcoma...Pegfilgrastim is used for all patients... N/A ......

For patients with relapsed/refractory lymphoma, pegfilgrastim administration after salvage therapy in an outpatient setting was feasible and safe for those who satisfied the outpatient management criteria.

P2, N=17, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025

P3, N=78, Completed, Children's Oncology Group | Active, not recruiting --> Completed

P1/2, N=138, Active, not recruiting, Mayo Clinic | Trial completion date: Jun 2023 --> Jul 2024

Part 1 consists of a dose-optimization stage and will randomize ∼50 subjects 1:1 to the treatment of luvelta at 4.3 mg/kg Q3W or luvelta 5.2 mg/kg Q3W + prophylactic pegfilgrastim for 2 cycles followed by 4.3 mg/kg Q3W. Key inclusion criteria are progressive PROC, up to 3 prior regimens, TPS of ≥25% for FolRα expression, and measurable disease. Key exclusion criteria are primary platinum refractory disease and prior treatment with a FolRα ADC or ADC containing a tubulin inhibitor.