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Neulasta

DRUG10 trials

Sponsors

Eastern Cooperative Oncology Group, OHSU Knight Cancer Institute, Amgen, Sidney Kimmel Cancer Center at Thomas Jefferson University, Columbia University

Conditions

Anaplastic Large Cell LymphomaBrain and Central Nervous System TumorsBreast CancerBreast NeoplasmsChemotherapy-Induced Febrile NeutropeniaDrug/Agent Toxicity by Tissue/OrganEarly Stage Breast CancerHealthy

Phase 1

Brentuximab Vedotin and Bendamustine for the Treatment of Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (ALCL)
CompletedNCT01657331
Columbia UniversityAnaplastic Large Cell Lymphoma, Hodgkin Lymphoma
Start: 2012-07-31End: 2020-04-30Updated: 2020-07-17
Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects
CompletedNCT03251248
Fresenius Kabi SwissBioSim GmbHHealthy
Start: 2017-08-22End: 2018-10-17Updated: 2019-07-02

Phase 2

Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma
CompletedNCT00068393
Eastern Cooperative Oncology GroupMetastatic Renal Cell Carcinoma, Renal Cell Carcinoma With Sarcomatoid Features
Start: 2004-02-24End: 2011-05-31Updated: 2023-07-07
Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen
TerminatedNCT00074165
OHSU Knight Cancer InstituteBrain and Central Nervous System Tumors, Drug/Agent Toxicity by Tissue/Organ, Lymphoma +1
Start: 2003-01-31End: 2010-12-31Updated: 2023-07-06
ACCELERATE: Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Pegfilgrastim and Darbepoetin Alfa Support for the Treatment of Women With Breast Cancer
CompletedNCT00261313
AmgenBreast Cancer
Start: 2005-12-31End: 2007-12-31Updated: 2010-02-26
Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy
CompletedNCT01437488
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityUrothelial Carcinoma
Start: 2012-02-16End: 2017-03-30Updated: 2025-05-04
Dacarbazine and Carmustine in Metastatic Melanoma
TerminatedNCT01692691
Western Regional Medical CenterMelanoma Metastatic
Start: 2012-08-31End: 2014-10-31Updated: 2018-04-04
Avoiding Growth Factor During Paclitaxel Treatment in Breast Cancer
CompletedNCT02698891
Dana-Farber Cancer InstituteEarly Stage Breast Cancer
Start: 2016-04-07End: 2021-11-30Updated: 2022-05-06

Phase 3

Efficacy and Safety Study With MYL-1401H and Neulasta
CompletedNCT02467868
Mylan Inc.Breast Neoplasms, Chemotherapy-Induced Febrile Neutropenia
Start: 2015-03-31End: 2016-02-29Updated: 2022-02-14
Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
CompletedNCT03252431
EVIVE BiotechnologyBreast Cancer, Neutropenia
Start: 2018-04-12End: 2020-03-05Updated: 2023-07-03

Related Papers

Efbemalenograstim alfa, an Fc fusion protein, long-acting granulocyte-colony stimulating factor for reducing the risk of febrile neutropenia following chemotherapy: results of a phase III trial
Supportive Care in Cancer2023-12-168 citations
Pharmacokinetics and Pharmacodynamics of a Proposed Pegfilgrastim Biosimilar MSB11455 Versus the Reference Pegfilgrastim Neulasta in Healthy Subjects: A Randomized, Double-blind Trial
Clinical Therapeutics2020-07-115 citations
Pharmacokinetic/pharmacodynamic assessment of a proposed biosimilar MSB11455 versus the currently licensed pegfilgrastim: A randomized, double-blind trial.
Journal of Clinical Oncology2019-05-201 citations
Avoiding peg-filgrastim (Peg-F) prophylaxis during the paclitaxel (T) portion of the dose-dense (DD) doxorubicin-cyclophosphamide (AC)-T regimen: A prospective study.
Journal of Clinical Oncology2019-05-20
Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia.
2019-03-0115 citations
Prolonged Overall Survival (OS) in a Subset of Responders to the Combination of Brentuximab Vedotin (Bv) and Bendamustine (B) in Heavily Treated Patients with Relapsed or Refractory Hodgkin Lymphoma (HL): Results of an International Multi- Center Phase I/II Experience
Blood2018-11-291 citations
Brentuximab vedotin plus bendamustine in relapsed or refractory Hodgkin's lymphoma: an international, multicentre, single-arm, phase 1-2 trial.
2017-12-2181 citations
Abstract OT1-01-09: Feasibility and safety of avoiding granulocyte colony-stimulating factor prophylaxis during the paclitaxel portion of dose dense doxorubicin-cyclophosphamide and paclitaxel regimen
Cancer Research2017-02-15
The Combination of Brentuximab Vedotin (Bv) and Bendamustine (B) Demonstrates Marked Activity in Heavily Treated Patients with Relapsed or Refractory Hodgkin Lymphoma (HL) and Anaplastic Large T-Cell Lymphoma (ALCL): Results of an International Multi Center Phase I/II Experience
Blood2015-12-0313 citations
A phase II study of cabazitaxel in patients with urothelial carcinoma who have disease progression following platinum-based chemotherapy.
Journal of Clinical Oncology2014-05-206 citations